A Phase 3 Clinical Outcomes Study to Compare the Incidence of Major Adverse Cardiovascular Events in Subjects Presenting With Acute Coronary Syndrome Treated With Losmapimod Compared to Placebo (LATITUDE-TIMI 60)

Acute Coronary Syndrome Clinical Trial

— LATITUDE  

Official title:

A Clinical Outcomes Study to Compare the Incidence of Major Adverse Cardiovascular Events in Subjects Presenting With Acute Coronary Syndrome Treated With Losmapimod Compared to Placebo (PM1116197) LosmApimod To Inhibit p38 MAP Kinase as a TherapeUtic Target and moDify Outcomes After an Acute Coronary syndromE (LATITUDE)-TIMI 60.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02145468
• Other study ID #: 116197
• Status: Completed
• Phase: Phase 3
• First received: May 15, 2014
• Last updated: March 30, 2017
• Start date: June 3, 2014
• Est. completion date: December 14, 2015

Study information

• Verified date: March 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Losmapimod is a new anti-inflammatory medication which potentially may benefit patients with Acute Coronary Syndrome, (ACS), a condition which includes heart attack. There is a growing understanding that the inflammatory response to ACS is integral to the subsequent evolution of plaque instability. Losmapimod inhibits p38 mitogen activated protein kinase (MAPK), an enzyme which may play a central role in inflammation in the setting of heart attack. Inhibition of p38 MAPK may stabilize atherosclerotic plaques, reduce the risk of subsequent plaque rupture, indirectly improve vascular function and prevent subsequent thrombosis, and thus reduce infarct size and the risk of subsequent cardiac events. This study will test whether losmapimod can safely reduce the risk of a subsequent cardiovascular event (such as death, heart attack, or near heart attack requiring urgent treatment ) when started immediately after ACS (specifically, heart attack). Patients who present with heart attack and qualify for the study will be randomly assigned to receive 3 months treatment with either losmapimod twice daily or placebo, which will be administered in addition to the usual standard of care therapies for heart attack. Following the in-hospital period, subjects will return for outpatient visits at 4 and 12 weeks, as well as a follow up visit at 24 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3503
• Est. completion date: December 14, 2015
• Est. primary completion date: December 14, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

• Signed written informed consent

• Men or women at least 35 years old. Women must be post-menopausal or using a highly effective method for avoidance of pregnancy

• Hospitalization for NSTEMI or STEMI (Universal Definition Type 1 MI)

• With the following timing of symptoms: NSTEMI: Presence of ischemic symptoms (>=5 minutes) at rest within 24 hours prior to randomization (may include qualifying episode). STEMI: Onset of qualifying ischemic symptoms within 12 hours of randomization.

• At least one of the following

• Age >=60 years at randomization.

• Myocardial infarction prior to the qualifying ACS event

• CABG prior to qualifying ACS event.

• NSTEMI with new ischemic ST-segment depression >= 0.1 mV in >= 2 contiguous leads.

• Diabetes mellitus requiring pharmacotherapy.

• Coexistent clinically diagnosed arterial disease

Exclusion Criteria:

• Unable to be randomized prior to coronary revascularization or fibrinolysis for the qualifying MI.

• Current severe heart failure or shock

• Ongoing clinical instability

• History of chronic liver disease

• Known severe renal impairment

• Any condition, other than vascular disease, with life expectancy <1 year that might prevent the subject from completing the study.

• Known active tuberculosis, HIV, active opportunistic or life threatening infections.

• Vaccination with a live attenuated vaccine within 6 weeks of randomization.

• Concomitant use of cytotoxic chemotherapy for cancer or known ongoing or anticipated use of chronic severe immunosuppressive agents

• Positive pregnancy test or is known to be pregnant or lactating

• Known alcohol or drug abuse within the past 6 months

• Any current mental condition, which may affect study compliance or prevent understanding of the aims, investigational procedures or possible consequences of the study.

• Participation in a study of an investigational medication within the past 30 days.

• Anticipated inability to comply with any study procedures, including participation in study visits according to the visit schedule through 24 weeks.

• Use of another investigational product within 30 days or 5 half-lives (whichever is longer) or according to local regulations, or currently participating in a study of an investigational device. Subjects must be randomized only one time in this investigational study

• Any other reason the investigator deems the subject to be unsuitable for the study

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• Losmapimod 7.5 mg twice daily
Subjects will receive Losmapimod 7.5 mg as film-coated, round, plain faced tablets.
• Placebo twice daily
Subjects will receive placebo as film-coated, round, plain faced tablets.
• Standard therapy
Subjects will receive standard therapy consistent with the appropriate guidelines from professional societies. The standard therapy includes nitrates, morphine sulfate, beta adrenergic blockers, renin-angiotensin aldosterone inhibitors, other anti-ischemic therapies, and analgesic therapy.

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Ciudad Autonoma de Buenos Aires
Argentina	GSK Investigational Site	Corrientes
Argentina	GSK Investigational Site	Quilmes	Buenos Aires
Argentina	GSK Investigational Site	Rosario	Santa Fe
Argentina	GSK Investigational Site	Santa Fe
Argentina	GSK Investigational Site	Venado Tuerto	Santa Fe
Australia	GSK Investigational Site	Bedford Park	South Australia
Australia	GSK Investigational Site	Brisbane	Queensland
Australia	GSK Investigational Site	Cairns	Queensland
Australia	GSK Investigational Site	Epping	Victoria
Australia	GSK Investigational Site	Geelong	Victoria
Australia	GSK Investigational Site	Herston	Queensland
Australia	GSK Investigational Site	Hobart	Tasmania
Australia	GSK Investigational Site	Murdoch	Western Australia
Australia	GSK Investigational Site	Nambour	Queensland
Australia	GSK Investigational Site	Nedlands	Western Australia
Belgium	GSK Investigational Site	Aalst
Belgium	GSK Investigational Site	Bonheiden
Belgium	GSK Investigational Site	Brasschaat
Belgium	GSK Investigational Site	Brugge
Belgium	GSK Investigational Site	Genk
Belgium	GSK Investigational Site	Gent
Belgium	GSK Investigational Site	Leuven
Belgium	GSK Investigational Site	Liège
Belgium	GSK Investigational Site	Mechelen
Belgium	GSK Investigational Site	Yvoir
Bulgaria	GSK Investigational Site	Blagoevgrad
Bulgaria	GSK Investigational Site	Dimitrovgrad
Bulgaria	GSK Investigational Site	Pazardjik
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Sofia
Canada	GSK Investigational Site	Kitchener	Ontario
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Scarborough	Ontario
Canada	GSK Investigational Site	Sherbrooke	Quebec
Canada	GSK Investigational Site	Sudbury	Ontario
Canada	GSK Investigational Site	Surrey	British Columbia
Canada	GSK Investigational Site	Thunder Bay	Ontario
Canada	GSK Investigational Site	Vancouver	British Columbia
Canada	GSK Investigational Site	Victoria	British Columbia
Chile	GSK Investigational Site	Concepción	Región Del Biobio
Chile	GSK Investigational Site	Santiago	Región Metro De Santiago
Chile	GSK Investigational Site	Santiago
Chile	GSK Investigational Site	Temuco	Región De La Araucania
Czech Republic	GSK Investigational Site	Brno
Czech Republic	GSK Investigational Site	Ceske Budejovice
Czech Republic	GSK Investigational Site	Hradec Kralove
Czech Republic	GSK Investigational Site	Liberec
Czech Republic	GSK Investigational Site	Ostrava.
Czech Republic	GSK Investigational Site	Pardubice
Czech Republic	GSK Investigational Site	Praha 10
Czech Republic	GSK Investigational Site	Praha 2
Czech Republic	GSK Investigational Site	Praha 6
Czech Republic	GSK Investigational Site	Usti nad Labem
Czech Republic	GSK Investigational Site	Zlin
Denmark	GSK Investigational Site	Hellerup
Denmark	GSK Investigational Site	Hvidovre
Denmark	GSK Investigational Site	København NV
Denmark	GSK Investigational Site	København S
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tartu
France	GSK Investigational Site	Besançon Cedex
France	GSK Investigational Site	Dijon
France	GSK Investigational Site	Montauban cedex
France	GSK Investigational Site	Nantes cedex 1
France	GSK Investigational Site	Paris Cedex 18
France	GSK Investigational Site	Pau
France	GSK Investigational Site	Strasbourg cedex
France	GSK Investigational Site	Toulouse cedex 09
France	GSK Investigational Site	Tourcoing cedex
France	GSK Investigational Site	Valenciennes Cedex
Germany	GSK Investigational Site	Aachen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Bad Krozingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Bad Nauheim	Hessen
Germany	GSK Investigational Site	Bernau	Brandenburg
Germany	GSK Investigational Site	Bielefeld	Nordrhein-Westfalen
Germany	GSK Investigational Site	Bonn	Nordrhein-Westfalen
Germany	GSK Investigational Site	Dortmund	Nordrhein-Westfalen
Germany	GSK Investigational Site	Esslingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Frankfurt	Hessen
Germany	GSK Investigational Site	Freiburg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Giessen	Hessen
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hannover	Niedersachsen
Germany	GSK Investigational Site	Kassel	Hessen
Germany	GSK Investigational Site	Langen	Hessen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Leverkusen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Mannheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Moenchengladbach	Nordrhein-Westfalen
Germany	GSK Investigational Site	Stuttgart	Baden-Wuerttemberg
Germany	GSK Investigational Site	Wuppertal	Nordrhein-Westfalen
Greece	GSK Investigational Site	Alexandroupolis
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Chalkida
Greece	GSK Investigational Site	N. Efkarpia, Thessaloniki
Greece	GSK Investigational Site	Thessaloniki
Hong Kong	GSK Investigational Site	Chai Wan
Hong Kong	GSK Investigational Site	Kowloon
Hong Kong	GSK Investigational Site	Shatin, New Territories
Hungary	GSK Investigational Site	Balatonfüred
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Szolnok
Hungary	GSK Investigational Site	Zalaegerszeg
Israel	GSK Investigational Site	Ashkelon
Israel	GSK Investigational Site	Haddera
Israel	GSK Investigational Site	Kfar Saba
Israel	GSK Investigational Site	Nahariya
Israel	GSK Investigational Site	Tel Aviv
Italy	GSK Investigational Site	Bergamo	Lombardia
Italy	GSK Investigational Site	Cremona	Lombardia
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Parma	Emilia-Romagna
Italy	GSK Investigational Site	Perugia	Umbria
Italy	GSK Investigational Site	Udine	Friuli-Venezia-Giulia
Korea, Republic of	GSK Investigational Site	Daejeon
Korea, Republic of	GSK Investigational Site	Ganwon-do
Korea, Republic of	GSK Investigational Site	Gwangju
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Mexico	GSK Investigational Site	Guadalajara	Jalisco
Mexico	GSK Investigational Site	Queretaro
Mexico	GSK Investigational Site	San Luis Potosi
Netherlands	GSK Investigational Site	Alkmaar
Netherlands	GSK Investigational Site	Amersfoort
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Delft
Netherlands	GSK Investigational Site	Deventer
Netherlands	GSK Investigational Site	Helmond
Netherlands	GSK Investigational Site	Nieuwegein
Netherlands	GSK Investigational Site	Nijmegen
Netherlands	GSK Investigational Site	Rotterdam
Netherlands	GSK Investigational Site	Schiedam
Netherlands	GSK Investigational Site	Sittard-geleen
Netherlands	GSK Investigational Site	Tilburg
Netherlands	GSK Investigational Site	Venlo
Netherlands	GSK Investigational Site	Zwolle
New Zealand	GSK Investigational Site	Christchurch
New Zealand	GSK Investigational Site	Grafton, Auckland
New Zealand	GSK Investigational Site	Hamilton
New Zealand	GSK Investigational Site	New Plymouth
New Zealand	GSK Investigational Site	Otahuhu, Auckland
New Zealand	GSK Investigational Site	Wellington South
Norway	GSK Investigational Site	Lillehammer
Norway	GSK Investigational Site	Oslo
Norway	GSK Investigational Site	Skien
Norway	GSK Investigational Site	Stavanger
Norway	GSK Investigational Site	Tromsø
Philippines	GSK Investigational Site	Manila
Philippines	GSK Investigational Site	Pasig City
Philippines	GSK Investigational Site	Quezon City
Philippines	GSK Investigational Site	San Juan
Poland	GSK Investigational Site	Bydgoszcz
Poland	GSK Investigational Site	Gdansk
Poland	GSK Investigational Site	Gdynia
Poland	GSK Investigational Site	Inowroclaw
Poland	GSK Investigational Site	Krakow
Poland	GSK Investigational Site	Lubin
Poland	GSK Investigational Site	Lublin
Poland	GSK Investigational Site	Olsztyn
Poland	GSK Investigational Site	Torun
Poland	GSK Investigational Site	Walbrzych
Poland	GSK Investigational Site	Warszawa
Poland	GSK Investigational Site	Wroclaw
Romania	GSK Investigational Site	Bucharest
Romania	GSK Investigational Site	Bucharest
Romania	GSK Investigational Site	Craiova
Russian Federation	GSK Investigational Site	Barnaul
Russian Federation	GSK Investigational Site	Gatchina
Russian Federation	GSK Investigational Site	Irkutsk
Russian Federation	GSK Investigational Site	Kemerovo
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Novosibirsk
Russian Federation	GSK Investigational Site	Perm
Russian Federation	GSK Investigational Site	Ryazan
Russian Federation	GSK Investigational Site	Ryazan
Russian Federation	GSK Investigational Site	Samara
Russian Federation	GSK Investigational Site	Saratov
Russian Federation	GSK Investigational Site	Saratov
Russian Federation	GSK Investigational Site	St-Petersburg
Russian Federation	GSK Investigational Site	St. Petersburg
Russian Federation	GSK Investigational Site	St. Petersburg
Russian Federation	GSK Investigational Site	Tomsk
Russian Federation	GSK Investigational Site	Tyumen
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Kosice
Slovakia	GSK Investigational Site	Martin
Slovakia	GSK Investigational Site	Nitra
South Africa	GSK Investigational Site	Bellville
South Africa	GSK Investigational Site	Cape Town
South Africa	GSK Investigational Site	Kuils River
South Africa	GSK Investigational Site	Parktown West
South Africa	GSK Investigational Site	Pinelands
South Africa	GSK Investigational Site	Somerset West
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Galdakano
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Majadahonda (Madrid)
Spain	GSK Investigational Site	Malaga
Spain	GSK Investigational Site	Marid
Spain	GSK Investigational Site	Santiago De Compostela
Spain	GSK Investigational Site	Sevilla
Sweden	GSK Investigational Site	Göteborg
Sweden	GSK Investigational Site	Göteborg
Sweden	GSK Investigational Site	Helsingborg
Sweden	GSK Investigational Site	Jönköping
Sweden	GSK Investigational Site	Örebro
Sweden	GSK Investigational Site	Östersund
Sweden	GSK Investigational Site	Stockholm
Sweden	GSK Investigational Site	Västerås
Taiwan	GSK Investigational Site	Changhua
Taiwan	GSK Investigational Site	Hualien
Taiwan	GSK Investigational Site	Kaohsiung
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Taipei City
Thailand	GSK Investigational Site	Bangkok
Thailand	GSK Investigational Site	Bangkok
Thailand	GSK Investigational Site	Bangkok
Thailand	GSK Investigational Site	Chiangmai
Ukraine	GSK Investigational Site	Cherkassy
Ukraine	GSK Investigational Site	Ivano-Frankivsk
Ukraine	GSK Investigational Site	Kharkiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Lviv
Ukraine	GSK Investigational Site	Uzhhorod
Ukraine	GSK Investigational Site	Zaporizhzhya
United Kingdom	GSK Investigational Site	Basingstoke
United Kingdom	GSK Investigational Site	Bournemouth
United Kingdom	GSK Investigational Site	Dundee
United Kingdom	GSK Investigational Site	Edinburgh
United Kingdom	GSK Investigational Site	Newcastle-upon-Tyne
United Kingdom	GSK Investigational Site	York
United States	GSK Investigational Site	Abington	Pennsylvania
United States	GSK Investigational Site	Albany	New York
United States	GSK Investigational Site	Alexandria	Louisiana
United States	GSK Investigational Site	Anderson	South Carolina
United States	GSK Investigational Site	Auburn	Maine
United States	GSK Investigational Site	Augusta	Georgia
United States	GSK Investigational Site	Aurora	Illinois
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Bakersfield	California
United States	GSK Investigational Site	Baton Rouge	Louisiana
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Canton	Ohio
United States	GSK Investigational Site	Chambersburg	Pennsylvania
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Chattanooga	Tennessee
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Coeur D Alene	Idaho
United States	GSK Investigational Site	Columbus	Ohio
United States	GSK Investigational Site	Cottonwood	Arizona
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Danville	Pennsylvania
United States	GSK Investigational Site	Daytona Beach	Florida
United States	GSK Investigational Site	Dearborn	Michigan
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Doylestown	Pennsylvania
United States	GSK Investigational Site	Duluth	Minnesota
United States	GSK Investigational Site	Elmhurst	Illinois
United States	GSK Investigational Site	Flemington	New Jersey
United States	GSK Investigational Site	Grand Blanc	Michigan
United States	GSK Investigational Site	Greensboro	North Carolina
United States	GSK Investigational Site	Huntington Beach	California
United States	GSK Investigational Site	Huntsville	Alabama
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Iowa City	Iowa
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Jacksonville Beach	Florida
United States	GSK Investigational Site	Jonesboro	Arkansas
United States	GSK Investigational Site	kansas City	Missouri
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Littleton	Colorado
United States	GSK Investigational Site	Long Beach	California
United States	GSK Investigational Site	Manitiowoc	Wisconsin
United States	GSK Investigational Site	Mansfield	Ohio
United States	GSK Investigational Site	Marquette	Michigan
United States	GSK Investigational Site	Minneapolis	Minnesota
United States	GSK Investigational Site	Mission Viejo	California
United States	GSK Investigational Site	Monterey	California
United States	GSK Investigational Site	Morgantown	West Virginia
United States	GSK Investigational Site	Muncie	Indiana
United States	GSK Investigational Site	Nashville	Tennessee
United States	GSK Investigational Site	Nashville	Tennessee
United States	GSK Investigational Site	Ocala	Florida
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Orange	California
United States	GSK Investigational Site	Pensacola	Florida
United States	GSK Investigational Site	Poughkeepsie	New York
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Rapid City	South Dakota
United States	GSK Investigational Site	Ridgewood	New Jersey
United States	GSK Investigational Site	Roanoke	Virginia
United States	GSK Investigational Site	Rochester	Michigan
United States	GSK Investigational Site	Rome	Georgia
United States	GSK Investigational Site	Round Rock	Texas
United States	GSK Investigational Site	Saint Paul	Minnesota
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	Slidell	Louisiana
United States	GSK Investigational Site	Springfield	Missouri
United States	GSK Investigational Site	St Louis	Missouri
United States	GSK Investigational Site	St. Louis	Missouri
United States	GSK Investigational Site	Stony Brook	New York
United States	GSK Investigational Site	Tacoma	Washington
United States	GSK Investigational Site	Tallahassee	Florida
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Teaneck	New Jersey
United States	GSK Investigational Site	Torrance	California
United States	GSK Investigational Site	Troy	Michigan
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Tuscon	Arizona
United States	GSK Investigational Site	Vero Beach	Florida
United States	GSK Investigational Site	Victoria	Texas
United States	GSK Investigational Site	Voorhees	New Jersey
United States	GSK Investigational Site	Wausau	Wisconsin
United States	GSK Investigational Site	West Des Moines	Iowa
United States	GSK Investigational Site	Wilkes-Barre	Pennsylvania
United States	GSK Investigational Site	York	Pennsylvania
United States	GSK Investigational Site	Ypsilanti	Michigan
United States	GSK Investigational Site	Zachary	Louisiana
United States	GSK Investigational Site	Zanesville	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
GlaxoSmithKline	The TIMI Study Group

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Bulgaria,  Canada,  Chile,  Czech Republic,  Denmark,  Estonia,  France,  Germany,  Greece,  Hong Kong,  Hungary,  Israel,  Italy,  Korea, Republic of,  Mexico,  Netherlands,  New Zealand,  Norway,  Philippines,  Poland,  Romania,  Russian Federation,  Slovakia,  South Africa,  Spain,  Sweden,  Taiwan,  Thailand,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with first occurrence of Major Adverse Cardiovascular Events (MACE) through Week 12	The primary efficacy endpoint is the composite measure of adjudicated MACE that includes the time to first occurrence of cardiovascular (CV) death (death due to a cardiovascular cause), MI (Myocardial Infarction) or SRI-UR (Severe Recurrent Ischemia requiring Urgent coronary artery Revascularization)	Through 12 weeks
Secondary	Number of participants with first occurrence of MACE through Week 24	Number of participants with first occurrence of MACE through Week 24 including CV death, MI or SRI-UR are presented. Death for which the CEC or investigator were unable to establish cause were analyzed as CV deaths.	Upto Week 24
Secondary	Number of participants with first occurrence of the composite of CV death or MI through to Week 12 and Week 24	Week 12 results are considered the principal secondary endpoint. Number of participants with first occurrence of the composite of CV death or MI through to Week 12 and Week 24 are summarized.	Week 12, Week 24
Secondary	Number of participants with first occurrence of the composite of CV death, MI or hospitalization for heart failure (HF) through to Week 12 and Week 24.	Number of participants with first occurrence of the composite of CV death, MI or hospitalization for HF through to Week 12 and Week 24 are presented.	Through 12 weeks with additional analyses through 4 and 24 weeks
Secondary	Number of participants with first occurrence of the expanded composite of arterial CV events defined as CV death, MI, SRI-UR or stroke through to Week 12 and Week 24	Number of participants with first occurrence of the expanded composite of arterial CV events defined as CV death, MI, SRI-UR or stroke through to Week 12 and Week 24 are presented.	Week 12, Week 24
Secondary	Number of participants with first occurrence of the composite of coronary events defined as CHD death, MI, SRI-UR or any unplanned coronary artery revascularization through to Week 12 and Week 24	Number of participants with first occurrence of the composite of coronary events defined as coronary heart disease (CHD) death, MI, SRI-UR or any unplanned coronary artery revascularization through to Week 12 and Week 24 are presented.	Week 12, Week 24
Secondary	Number of participants with first occurrence of the composite of CV death or hospitalization for HF through to Week 12 and Week 24	Number of participants with first occurrence of the composite of CV death or hospitalization for HF through to Week 12 and Week 24 are presented.	Week 12, Week 24
Secondary	Number of participants with first occurrence of the composite of CV death, MI or stroke through to Week 12 and Week 24	Number of participants with first occurrence of the composite of CV death, MI or stroke through to Week 12 and Week 24 are presented.	Week 12, Week 24
Secondary	Number of participants with first occurrence of the expanded composite of CV death, MI, SRI-UR, stroke or hospitalization for HF through to Week 12 and Week 24	Number of participants with first occurrence of the expanded composite of CV death, MI, SRI-UR, stroke or hospitalization for HF through to Week 12 and Week 24 are presented.	Week 12, Week 24
Secondary	Number of participants with first occurrence of the composite of CHD death, MI or SRI-UR through to Week 12 and Week 24	Number of participants with first occurrence of the composite of CHD death, MI or SRI-UR through to Week 12 and Week 24 are presented.	Week 12, Week 24
Secondary	Number of participants with first occurrence of the composite of CHD death or MI through to Week 12 and Week 24	Number of participants with first occurrence of the composite of CHD death or MI through to Week 12 and Week 24 are presented.	Week 12, Week 24
Secondary	Number of participants with first occurrence of the composite of all-cause death, MI or SRI-UR through to Week 12 and Week 24	Number of participants with first occurrence of the composite of all-cause death, MI or SRI-UR through to Week 12 and Week 24 are presented.	Week 12, Week 24
Secondary	Number of participants with first occurrence of the composite of all-cause death or MI through to Week 12 and Week 24	Number of participants with first occurrence of the composite of all-cause death or MI through to Week 12 and Week 24 are presented.	Week 12, Week 24
Secondary	Number of participants with first occurrence of the composite of CV death, type I (spontaneous) MI or SRI-UR through to Week 12 and Week 24	Number of participants with first occurrence of the composite of CV death, type I (spontaneous) MI or SRI-UR through to Week 12 and Week 24 are presented.	Week 12, Week 24
Secondary	Number of participants with first occurrence of the composite of CV death or type I (spontaneous) MI through to Week 12 and Week 24	Number of participants with first occurrence of the composite of CV death or type I (spontaneous) MI through to Week 12 and Week 24 are presented.	Week 12, Week 24
Secondary	Number of participants with first occurrence of definite or probable stent thrombosis through to Week 12 and Week 24	Number of participants with first occurrence of definite or probable stent thrombosis through to Week 12 and Week 24 are presented. Participants receiving stent prior to randomization or during the study prior to Week 12 were included.	Week 12, Week 24
Secondary	Number of participants re-hospitalized within 30 days of discharge	Participants who had a death or re-hospitalization within 30 days of discharge, plus participants who were never discharged from the initial hospitalization were included.	Within up to 30 days of post discharge
Secondary	Number of participants with all-cause mortality through to Week 12 and Week 24	Number of participants with all-cause mortality through to Week 12 and Week 24 are presented.	Week 12, Week 24
Secondary	Number of participants with CV death events through to Week 12 and Week 24	Number of participants with CV death events through to Week 12 and Week 24 are presented.	Week 12, Week 24
Secondary	Number of participants with CHD death events through to Week 12 and Week 24	Number of participants with CHD death events through to Week 12 and Week 24 are presented.	Week 12, Week 24
Secondary	Number of participants with first occurrence of myocardial infarction (fatal and non-fatal) events through to Week 12 and Week 24	Number of participants with first occurrence of myocardial infarction (fatal and non-fatal) events through to Week 12 and Week 24 are presented.	Week 12, Week 24
Secondary	Number of participants with first occurrence of type I (spontaneous) MI events through to Week 12 and Week 24	Number of participants with first occurrence of type I (spontaneous) MI events through to Week 12 and Week 24 are presented.	Week 12, Week 24
Secondary	Number of participants with first occurrence of SRI-UR events through to Week 12 and Week 24	Number of participants with first occurrence of SRI-UR events through to Week 12 and Week 24 are presented.	Week 12, Week 24
Secondary	Number of participants with first occurrence of stroke (fatal and non-fatal) events through to Week 12 and Week 24	Number of participants with first occurrence of stroke (fatal and non-fatal) events through to Week 12 and Week 24 are presented.	Week 12, Week 24
Secondary	Number of participants with first occurrence of hospitalization for HF through to Week 12 and Week 24	Number of participants with first occurrence of hospitalization for HF through to Week 12 and Week 24 are presented.	Week 12, Week 24
Secondary	Number of participants with first occurrence of any unplanned coronary revascularization through to Week 12 and Week 24	Number of participants with first occurrence of any unplanned coronary revascularization through to Week 12 and Week 24 are presented.	Week 12, Week 24

External Links

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