A Comparison of Ticagrelor (AZD6140) and Clopidogrel in Patients With Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

— PLATO  

Official title:

A Randomised, Double-blind, Parallel Group, Phase 3, Efficacy and Safety Study of Ticagrelor Compared With Clopidogrel for Prevention of Vascular Events in Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS) [PLATO- a Study of PLATelet Inhibition and Patient Outcomes]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00391872
• Other study ID #: D5130C05262
• Secondary ID: PLATO
• Status: Completed
• Phase: Phase 3
• First received: October 23, 2006
• Last updated: February 10, 2012
• Start date: October 2006
• Est. completion date: March 2009

Study information

• Verified date: February 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Ticagrelor is a new, reversible binding, anti-platelet medication. Anti-platelet medications work to prevent the formation of blood clots. Ticagrelor is being developed as a treatment for patients with acute coronary syndrome (ACS). ACS is a term that is used to describe both heart attacks in progress or the imminent threat of a heart attack. ACS is usually caused by the formation of a blood clot in an artery that partially or totally blocks the blood supply to a portion of the heart muscle. Ticagrelor will be compared with clopidogrel to determine which drug, when either is used in conjunction with aspirin, is better at reducing deaths from vascular causes, future heart attacks and/or strokes in patients with ACS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18624
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female 18 years or older who has been hospitalised for chest pain and potential ACS

• Females of child-bearing potential must have a negative pregnancy test at enrollment and be willing to use 2 methods of reliable contraception

Exclusion Criteria:

• Persons with moderate or severe liver disease

• Persons who have already been treated with an invasive (angioplasty) procedure for the current episode of ACS

• Persons who are being treated with blood clotting agents that cannot be stopped

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• Ticagrelor
Ticagrelor (AZD6140) 90 mg twice daily dose (BD)
• Clopidogrel
Clopidogrel 75 mg once daily dose (ODD)

Locations

Country	Name	City	State
Argentina	Research Site	Adrogue	Buenos Aires
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Capital Federal	Buenos Aires
Argentina	Research Site	Ciudad Autonoma de Bs. As.	Buenos Aires
Argentina	Research Site	Cordoba
Argentina	Research Site	Corrientes
Argentina	Research Site	Moron	Pcia. de Buenos Aires
Argentina	Research Site	Quilmes	Buenos Aires
Argentina	Research Site	Rosario	Santa Fe
Argentina	Research Site	Salta
Argentina	Research Site	San Miguel de Tucuman
Argentina	Research Site	Santa Fe
Argentina	Research Site	Tucuman	Tucuman - Argentina
Australia	Research Site	Bedford Park	South Australia
Australia	Research Site	Bruce	Australian Capital Territory
Australia	Research Site	Chermside	Queensland
Australia	Research Site	Dandenong	Victoria
Australia	Research Site	Geelong	Victoria
Australia	Research Site	Herston	Queensland
Australia	Research Site	Melbourne	Victoria
Australia	Research Site	Perth	Western Australia
Australia	Research Site	Woolloongabba	Queensland
Austria	Research Site	Feldkirch
Austria	Research Site	Freistadt
Austria	Research Site	Graz
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United States	Research Site	Lubbock	Texas
United States	Research Site	Melbourne	Florida
United States	Research Site	Memphis	Tennessee
United States	Research Site	Miami Beach	Florida
United States	Research Site	Minneapolis	Minnesota
United States	Research Site	Mobile	Alabama
United States	Research Site	Morgantown	West Virginia
United States	Research Site	Muncie	Indiana
United States	Research Site	New Hartford	New York
United States	Research Site	New York	New York
United States	Research Site	Newark	Delaware
United States	Research Site	Newark	New Jersey
United States	Research Site	Norfolk	Virginia
United States	Research Site	Oakland	New Jersey
United States	Research Site	Ocala	Florida
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Olathe	Kansas
United States	Research Site	Omaha	Nebraska
United States	Research Site	Orlando	Florida
United States	Research Site	Ormond Beach	Florida
United States	Research Site	Papillion	Nebraska
United States	Research Site	Park Ridge	Illinois
United States	Research Site	Paterson	New Jersey
United States	Research Site	Pensacola	Florida
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Pontiac	Michigan
United States	Research Site	Providence	Rhode Island
United States	Research Site	Raleigh	North Carolina
United States	Research Site	Rapid City	South Dakota
United States	Research Site	Rochester	New York
United States	Research Site	Rock Island	Illinois
United States	Research Site	Rockford	Illinois
United States	Research Site	Roseville	California
United States	Research Site	Royal Oak	Michigan
United States	Research Site	Sacramento	California
United States	Research Site	Saginaw	Michigan
United States	Research Site	Salisbury	Maryland
United States	Research Site	San Antonio	Texas
United States	Research Site	San Diego	California
United States	Research Site	San Marcos	Texas
United States	Research Site	Sarasota	Florida
United States	Research Site	Sayre	Pennsylvania
United States	Research Site	Sellersville	Pennsylvania
United States	Research Site	Shreveport	Louisiana
United States	Research Site	Springfield	Massachusetts
United States	Research Site	St Louis	Missouri
United States	Research Site	St Paul	Minnesota
United States	Research Site	St Petersburg	Florida
United States	Research Site	Syracuse	New York
United States	Research Site	Tacoma	Washington
United States	Research Site	Torrance	California
United States	Research Site	Troy	Michigan
United States	Research Site	Tucson	Arizona
United States	Research Site	Tulsa	Oklahoma
United States	Research Site	Tupelo	Mississippi
United States	Research Site	Tyler	Texas
United States	Research Site	Valparaiso	Indiana
United States	Research Site	Victoria	Texas
United States	Research Site	Wakefield	Rhode Island
United States	Research Site	Washington	District of Columbia
United States	Research Site	West Des Moines	Iowa
United States	Research Site	Williamsville	New York
United States	Research Site	Winchester	Virginia
United States	Research Site	Winston-salem	North Carolina
United States	Research Site	Wormleysburg	Pennsylvania
United States	Research Site	York	Pennsylvania
United States	Research Site	Ypsilanti	Michigan
United States	Research Site	Zanesville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  China,  Czech Republic,  Denmark,  Finland,  France,  Georgia,  Germany,  Greece,  Hong Kong,  Hungary,  India,  Indonesia,  Israel,  Italy,  Korea, Republic of,  Malaysia,  Mexico,  Netherlands,  Norway,  Philippines,  Poland,  Portugal,  Puerto Rico,  Romania,  Russian Federation,  Singapore,  Slovakia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke	Participants with death from vascular causes, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. Intention To Treat (ITT) analysis of whole population. Events were adjudicated by an endpoint committee.	Randomization up to 12 months	No
Primary	Participants With Any Major Bleeding Event	Participants with major (fatal/life-threatening or other) bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.	First dosing up to 12 months	Yes
Secondary	Participants With Any Event From the Composite of Death From Vascular Causes, MI, and Stroke for the Subgroup of Patients With Intent for Invasive Management at Randomization	Participants with death from vascular causes, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT analysis of intent for invasive management population. Events were adjudicated by an endpoint committee.	Randomization up to 12 months	No
Secondary	Participants With Any Event From the Composite of All-cause Mortality, MI, and Stroke	Participants with death from any cause, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal of consent or date of scheduled withdrawal from therapy. ITT analysis of whole population. Events were adjudicated by an endpoint committee.	Randomization up to 12 months	No
Secondary	Participants With Any Event From the Composite of Death From Vascular Causes, MI (Including Silent), Stroke, Recurrent Ischemia, Transient Ischemic Attack (TIA) and Other Arterial Thrombotic Events.	Participants with death from vascular causes, MI, stroke, recurrent ischemia, or other thrombotic events. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT analysis of whole population. Events were adjudicated.	Randomization up to 12 months	No
Secondary	Participants With MI Event	Participants with MI event. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.	Randomization up to 12 months	No
Secondary	Participants With Death From Vascular Causes	Participants with death from vascular causes. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.	Randomization up to 12 months	No
Secondary	Participants With Stroke	Participants with stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.	Randomization up to 12 months	No
Secondary	Participants With Death From Any Cause	Participants with death from any cause. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.	Randomization up to 12 months	No
Secondary	Participants With Non-CABG (Coronary Artery Bypass Graft) Related Major Bleeding	Participants with non CABG related major (fatal/life-threatening or other) bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.	First dosing up to 12 months	Yes
Secondary	Participants With Major or Minor Bleeding	Participants with major (fatal/life-threatening or other) or minor bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.	First dosing up to 12 months	Yes
Secondary	Participants With Non-procedural Major Bleeding	Participants with non-procedural major bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.	First dosing up to 12 months	Yes
Secondary	Participants With Coronary Artery Bypass Graft (CABG) Major Bleeding	Participants with a major CABG-related bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. All CABG surgeries were submitted for adjudication by an endpoint committee as potential bleeds.	First dosing up to 12 months	Yes
Secondary	Participants With Coronary Artery Bypass Graft (CABG) Major Fatal/Life-threatening Bleeding	Number of participants with a major fatal/life-threatening CABG-related bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. All CABG surgeries were submitted for adjudication by an endpoint committee as potential bleeds.	First dosing up to 12 months	Yes
Secondary	Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24-hour ECG Recorders for 1 Week Following Randomization	Number of participants who were observed to have at least 1 ventricular pause of at least 3 seconds. Population is all patients who were observed over 2 week-long periods. Pauses were flagged algorithmically and confirmed by Thrombolysis in Myocardial Infarction (TIMI) group cardiologists.	1-week period following randomization	Yes
Secondary	Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24 Hour ECG Recorders for 1 Week at 1 Month Following Randomization	Number of participants who were observed to have at least 1 ventricular pause of at least 3 seconds. Population is all patients who were observed over 2 week-long periods. Pauses were flagged algorithmically and confirmed by TIMI cardiologists.	1-week period following randomization	Yes