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NCT00621855 Clinical Trial

RE-DEEM Dose Finding Study for Dabigatran Etexilate in Patients With Acute Coronary Syndrome

Coronary Disease Clinical Trial

Official title:
RandomizEd Dabigatran Etexilate Dose Finding Study in Patients With Acute Coronary Syndromes Post Index Event With Additional Risk Factors for Cardiovascular Complications Also Receiving Aspirin and Clopidogrel: Multi-centre, Prospective, Placebo Controlled, Cohort Dose Escalation Study (RE-DEEM)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00621855
Other study ID # 1160.67
Secondary ID RE-DEEM2007-0043
Status Completed
Phase Phase 2
First received February 13, 2008
Last updated February 10, 2014
Start date March 2008

Study information
Verified date February 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicines and Health Products, FAMHPBulgaria: Bulgarian Drug Agency, BG-1504 SofiaCanada: Health Canada, Therapeutic Products DirectorateCzech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10Denmark: The Danish Medicines AgencyFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Georgia: State Regulation Agency of Medical Activity, GE-0160 TbilisiGermany: BfArM-Federal Authorities for Drugs and Medical DevicesGreat Britain: MHRAHungary: National Institute of Pharmacy, H-1051 BudapestIndia: Drug Control General of IndiaIreland: Irish Medicines BoardItaly: Comitato Etico Unico per la Provincia di Parma - Azienda Ospedaliera di ParmaKorea, Republic of: KOREA Food and Drug Administration (KFDA)Netherlands: Central Committee on Research Involving Human Subjects (CCMO)Norway: Norwegian Medicines AgencyPoland: Urzad Rejestracji Produktow Leczniczych, Wyrobow, Medycznych i Produktow Biobojczych, PL-00725 WarsawRomania: National Medicines Agency, BucharestRussia: Ministry of Healthcare and Social Development of Russian Federation, MoscowSpain: Agencia Española de Medicamentos y Productos SantariosSweden: Medical Products AgencyUkraine: Ministry of Health Care of Ukraine (MoH of Ukraine)United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this trial is to evaluate the safety and indicators of efficacy of up to 4 doses of orally administered dabigatran etexilate, administered twice daily, compared to placebo when given in addition to dual antiplatelet treatment in patients with an index event (MI) at high risk for new ischaemic cardiovascular events.

Recruitment information / eligibility
Status Completed
Enrollment 1878
Est. completion date
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion criteria Patients with acute coronary syndromes with at least one additional risk factor for cardiovascular complications.

Exclusion criteria

1. Long term treatment with any other oral anticoagulant

2. Severe/disabling stroke within last 6 months

3. Conditions associated with increased bleeding risk

4. Anaemia or thrombocytopenia

5. Severe renal impairment

6. Liver disease

7. Positive pregnancy test

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• placebo
matched placebo
• dabigatran etexilate
capsules, twice daily, 26 weeks treatment
• dabigatran etexilate
capsules, twice daily, 26 weeks treatment
• dabigatran etexilate
capsules, twice daily, 26 weeks treatment
• dabigatran etexilate
capsules, twice daily, 26 weeks treatment

Locations
Country Name City State
Belgium 1160.67.32008 Boehringer Ingelheim Investigational Site Bouge/Namur
Belgium 1160.67.32011 Boehringer Ingelheim Investigational Site Brasschaat
Belgium 1160.67.32005 Boehringer Ingelheim Investigational Site Edegem
Belgium 1160.67.32002 Boehringer Ingelheim Investigational Site Genk
Belgium 1160.67.32006 Boehringer Ingelheim Investigational Site Gilly
Belgium 1160.67.32003 Boehringer Ingelheim Investigational Site Hasselt
Belgium 1160.67.32001 Boehringer Ingelheim Investigational Site Leuven
Belgium 1160.67.32004 Boehringer Ingelheim Investigational Site Tienen
Bulgaria 1160.67.59007 Boehringer Ingelheim Investigational Site Bourgas
Bulgaria 1160.67.59009 Boehringer Ingelheim Investigational Site Dimitrovgrad
Bulgaria 1160.67.59003 Boehringer Ingelheim Investigational Site Pleven
Bulgaria 1160.67.59012 Boehringer Ingelheim Investigational Site Pleven
Bulgaria 1160.67.59006 Boehringer Ingelheim Investigational Site Rousse
Bulgaria 1160.67.59001 Boehringer Ingelheim Investigational Site Sofia
Bulgaria 1160.67.59002 Boehringer Ingelheim Investigational Site Sofia
Bulgaria 1160.67.59004 Boehringer Ingelheim Investigational Site Sofia
Bulgaria 1160.67.59005 Boehringer Ingelheim Investigational Site Sofia
Bulgaria 1160.67.59008 Boehringer Ingelheim Investigational Site Sofia
Bulgaria 1160.67.59010 Boehringer Ingelheim Investigational Site Sofia
Canada 1160.67.11009 Boehringer Ingelheim Investigational Site Calgary Alberta
Canada 1160.67.11012 Boehringer Ingelheim Investigational Site Cambridge Ontario
Canada 1160.67.11008 Boehringer Ingelheim Investigational Site Hamilton Ontario
Canada 1160.67.11018 Boehringer Ingelheim Investigational Site London Ontario
Canada 1160.67.11017 Boehringer Ingelheim Investigational Site Mississauga Ontario
Canada 1160.67.11004 Boehringer Ingelheim Investigational Site Montreal Quebec
Canada 1160.67.11016 Boehringer Ingelheim Investigational Site Montreal Quebec
Canada 1160.67.11014 Boehringer Ingelheim Investigational Site Quebec
Canada 1160.67.11010 Boehringer Ingelheim Investigational Site Sudbury Ontario
Canada 1160.67.11020 Boehringer Ingelheim Investigational Site Sudbury Ontario
Canada 1160.67.11006 Boehringer Ingelheim Investigational Site Terrebonne Quebec
Canada 1160.67.11003 Boehringer Ingelheim Investigational Site Vancouver British Columbia
Czech Republic 1160.67.42007 Boehringer Ingelheim Investigational Site Hradec Kralove
Czech Republic 1160.67.42005 Boehringer Ingelheim Investigational Site Litomerice
Czech Republic 1160.67.42008 Boehringer Ingelheim Investigational Site Ostrava
Czech Republic 1160.67.42001 Boehringer Ingelheim Investigational Site Prague
Czech Republic 1160.67.42003 Boehringer Ingelheim Investigational Site Teplice
Czech Republic 1160.67.42002 Boehringer Ingelheim Investigational Site Zlin
Denmark 1160.67.45001 Boehringer Ingelheim Investigational Site Aarhus C
Denmark 1160.67.45003 Boehringer Ingelheim Investigational Site Hvidovre
Denmark 1160.67.45002 Boehringer Ingelheim Investigational Site Odense
Denmark 1160.67.45004 Boehringer Ingelheim Investigational Site Roskilde
Finland 1160.67.58001 Boehringer Ingelheim Investigational Site HUS
Finland 1160.67.58004 Boehringer Ingelheim Investigational Site Jyväskylä
Finland 1160.67.58003 Boehringer Ingelheim Investigational Site Kuopio
Finland 1160.67.58002 Boehringer Ingelheim Investigational Site Pori
France 1160.67.3305A Boehringer Ingelheim Investigational Site Brest Cedex
France 1160.67.3305B Boehringer Ingelheim Investigational Site Brest Cedex
France 1160.67.3303A Boehringer Ingelheim Investigational Site Dijon Cedex
France 1160.67.3303B Boehringer Ingelheim Investigational Site Dijon Cedex
France 1160.67.3303C Boehringer Ingelheim Investigational Site Dijon Cedex
France 1160.67.3303D Boehringer Ingelheim Investigational Site Dijon Cedex
France 1160.67.3301A Boehringer Ingelheim Investigational Site Paris
Georgia 1160.67.95001 Boehringer Ingelheim Investigational Site Tbilisi
Georgia 1160.67.95002 Boehringer Ingelheim Investigational Site Tbilisi
Georgia 1160.67.95003 Boehringer Ingelheim Investigational Site Tbilisi
Georgia 1160.67.95004 Boehringer Ingelheim Investigational Site Tbilisi
Georgia 1160.67.95005 Boehringer Ingelheim Investigational Site Tbilisi
Georgia 1160.67.95006 Boehringer Ingelheim Investigational Site Tbilisi
Germany 1160.67.49001 Boehringer Ingelheim Investigational Site Berlin
Germany 1160.67.49007 Boehringer Ingelheim Investigational Site Berlin
Germany 1160.67.49017 Boehringer Ingelheim Investigational Site Dresden
Germany 1160.67.49006 Boehringer Ingelheim Investigational Site Hannover
Germany 1160.67.49019 Boehringer Ingelheim Investigational Site Homburg/Saar
Germany 1160.67.49008 Boehringer Ingelheim Investigational Site Ludwigshafen am Rhein
Germany 1160.67.49015 Boehringer Ingelheim Investigational Site Neuss
Germany 1160.67.49004 Boehringer Ingelheim Investigational Site Rostock
Hungary 1160.67.36001 Boehringer Ingelheim Investigational Site Budapest
Hungary 1160.67.36003 Boehringer Ingelheim Investigational Site Budapest
Hungary 1160.67.36004 Boehringer Ingelheim Investigational Site Budapest
Hungary 1160.67.36002 Boehringer Ingelheim Investigational Site Debrecen
Hungary 1160.67.36007 Boehringer Ingelheim Investigational Site Kecskemet
Hungary 1160.67.36006 Boehringer Ingelheim Investigational Site Komarom
Hungary 1160.67.36008 Boehringer Ingelheim Investigational Site Miskolc
Hungary 1160.67.36009 Boehringer Ingelheim Investigational Site Mosonmagyarovar
Hungary 1160.67.36005 Boehringer Ingelheim Investigational Site Zalaegerszeg
India 1160.67.91004 Boehringer Ingelheim Investigational Site Amedabad
India 1160.67.91001 Boehringer Ingelheim Investigational Site Chennai
India 1160.67.91005 Boehringer Ingelheim Investigational Site Hyderabad
India 1160.67.91007 Boehringer Ingelheim Investigational Site Lucknow
India 1160.67.91002 Boehringer Ingelheim Investigational Site Mumbai
India 1160.67.91003 Boehringer Ingelheim Investigational Site Pune
India 1160.67.91006 Boehringer Ingelheim Investigational Site Pune
Ireland 1160.67.53001 Boehringer Ingelheim Investigational Site Dublin
Ireland 1160.67.53002 Boehringer Ingelheim Investigational Site Dublin
Italy 1160.67.39006 Boehringer Ingelheim Investigational Site Ascoli Piceno
Italy 1160.67.39003 Boehringer Ingelheim Investigational Site Milano
Italy 1160.67.39005 Boehringer Ingelheim Investigational Site Milano
Italy 1160.67.39001 Boehringer Ingelheim Investigational Site Parma
Italy 1160.67.39002 Boehringer Ingelheim Investigational Site S. Maria Capua Vetere (CE)
Italy 1160.67.39004 Boehringer Ingelheim Investigational Site Torino
Korea, Republic of 1160.67.82010 Boehringer Ingelheim Investigational Site Busan
Korea, Republic of 1160.67.82008 Boehringer Ingelheim Investigational Site Daegu
Korea, Republic of 1160.67.82009 Boehringer Ingelheim Investigational Site Daegu
Korea, Republic of 1160.67.82013 Boehringer Ingelheim Investigational Site Daejeon
Korea, Republic of 1160.67.82006 Boehringer Ingelheim Investigational Site Daejoen
Korea, Republic of 1160.67.82007 Boehringer Ingelheim Investigational Site Incheon
Korea, Republic of 1160.67.82012 Boehringer Ingelheim Investigational Site Jeonju
Korea, Republic of 1160.67.82005 Boehringer Ingelheim Investigational Site Kwang-Ju
Korea, Republic of 1160.67.82011 Boehringer Ingelheim Investigational Site Pusan
Korea, Republic of 1160.67.82001 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 1160.67.82002 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 1160.67.82003 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 1160.67.82004 Boehringer Ingelheim Investigational Site Seoul
Netherlands 1160.67.31001 Boehringer Ingelheim Investigational Site Amsterdam
Netherlands 1160.67.31003 Boehringer Ingelheim Investigational Site Den Bosch
Netherlands 1160.67.31007 Boehringer Ingelheim Investigational Site Den Haag
Netherlands 1160.67.31009 Boehringer Ingelheim Investigational Site Ede
Netherlands 1160.67.31002 Boehringer Ingelheim Investigational Site Groningen
Netherlands 1160.67.31006 Boehringer Ingelheim Investigational Site Helmond
Netherlands 1160.67.31011 Boehringer Ingelheim Investigational Site Hoogeveen
Netherlands 1160.67.31005 Boehringer Ingelheim Investigational Site Rotterdam
Netherlands 1160.67.31008 Boehringer Ingelheim Investigational Site Spijkenisse
Netherlands 1160.67.31004 Boehringer Ingelheim Investigational Site Tilburg
Norway 1160.67.47005 Boehringer Ingelheim Investigational Site Drammen
Norway 1160.67.47002 Boehringer Ingelheim Investigational Site Hamar
Norway 1160.67.47003 Boehringer Ingelheim Investigational Site Haugesund
Norway 1160.67.47004 Boehringer Ingelheim Investigational Site Hønefoss
Norway 1160.67.47001 Boehringer Ingelheim Investigational Site Oslo
Poland 1160.67.48003 Boehringer Ingelheim Investigational Site Bydgoszcz
Poland 1160.67.48006 Boehringer Ingelheim Investigational Site Bydgoszcz
Poland 1160.67.48004 Boehringer Ingelheim Investigational Site Gdynia
Poland 1160.67.48005 Boehringer Ingelheim Investigational Site Inowroclaw
Poland 1160.67.48002 Boehringer Ingelheim Investigational Site Sopot
Poland 1160.67.48001 Boehringer Ingelheim Investigational Site Warsaw
Romania 1160.67.40006 Boehringer Ingelheim Investigational Site Baia Mare
Romania 1160.67.40005 Boehringer Ingelheim Investigational Site Braila
Romania 1160.67.40001 Boehringer Ingelheim Investigational Site Bucharest
Romania 1160.67.40003 Boehringer Ingelheim Investigational Site Bucharest
Romania 1160.67.40004 Boehringer Ingelheim Investigational Site Bucharest
Romania 1160.67.40002 Boehringer Ingelheim Investigational Site Oradea
Romania 1160.67.40007 Boehringer Ingelheim Investigational Site Tg. Mures
Russian Federation 1160.67.70001 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1160.67.70002 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1160.67.70003 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1160.67.70004 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1160.67.70005 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1160.67.70006 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1160.67.70007 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1160.67.70010 Boehringer Ingelheim Investigational Site Saratov
Russian Federation 1160.67.70011 Boehringer Ingelheim Investigational Site Saratov
Russian Federation 1160.67.70008 Boehringer Ingelheim Investigational Site St. Petersburg
Russian Federation 1160.67.70009 Boehringer Ingelheim Investigational Site St. Petersburg
Spain 1160.67.34001 Boehringer Ingelheim Investigational Site Barcelona
Spain 1160.67.34002 Boehringer Ingelheim Investigational Site Barcelona
Spain 1160.67.34005 Boehringer Ingelheim Investigational Site Madrid
Spain 1160.67.34006 Boehringer Ingelheim Investigational Site Madrid
Spain 1160.67.34003 Boehringer Ingelheim Investigational Site Sabadell (Barcelona)
Spain 1160.67.34004 Boehringer Ingelheim Investigational Site Tarragona
Sweden 1160.67.46004 Boehringer Ingelheim Investigational Site Göteborg
Sweden 1160.67.46006 Boehringer Ingelheim Investigational Site Göteborg
Sweden 1160.67.46007 Boehringer Ingelheim Investigational Site Malmö
Sweden 1160.67.46005 Boehringer Ingelheim Investigational Site Motala
Sweden 1160.67.46002 Boehringer Ingelheim Investigational Site Stockholm
Sweden 1160.67.46001 Boehringer Ingelheim Investigational Site Uppsala
Sweden 1160.67.46003 Boehringer Ingelheim Investigational Site Vaesteraas
Ukraine 1160.67.38002 Boehringer Ingelheim Investigational Site Ivano-Frankovsk
Ukraine 1160.67.38004 Boehringer Ingelheim Investigational Site Kharkov
Ukraine 1160.67.38007 Boehringer Ingelheim Investigational Site Kharkov
Ukraine 1160.67.38001 Boehringer Ingelheim Investigational Site Kiev
Ukraine 1160.67.38003 Boehringer Ingelheim Investigational Site Kiev
Ukraine 1160.67.38005 Boehringer Ingelheim Investigational Site Kiev
Ukraine 1160.67.38008 Boehringer Ingelheim Investigational Site Nikolayev
Ukraine 1160.67.38006 Boehringer Ingelheim Investigational Site Odessa
United Kingdom 1160.67.44003 Boehringer Ingelheim Investigational Site Brighton
United Kingdom 1160.67.44002 Boehringer Ingelheim Investigational Site Exeter
United Kingdom 1160.67.44001 Boehringer Ingelheim Investigational Site Middlesbrough
United States 1160.67.10002 Boehringer Ingelheim Investigational Site Clearwater Florida

Sponsors (2)
Lead Sponsor Collaborator
Boehringer Ingelheim Uppsala University

Countries where clinical trial is conducted

United States,  Belgium,  Bulgaria,  Canada,  Czech Republic,  Denmark,  Finland,  France,  Georgia,  Germany,  Hungary,  India,  Ireland,  Italy,  Korea, Republic of,  Netherlands,  Norway,  Poland,  Romania,  Russian Federation,  Spain,  Sweden,  Ukraine,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants Displaying the Composite of Major and Clinically Relevant Minor Bleeding Events During Total Observation Time International Society Thrombosis and Haemostasis (ISTH) definition of a major bleed, and clinically relevant minor bleed.
A bleeding event was considered as major if it was fatal, was a symptomatic bleeding in a critical area or organ (intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome), or caused a fall in haemoglobin level of =2 g/dL (=1.24 mmol/L), or led to transfusion of =2 units of whole blood or red cells.
All non major bleeding events were classified as minor bleeds; minor bleeds were subdivided in clinically relevant minor bleeds and not clinically relevant minor bleeds. A CRBE was defined as an acute or subacute clinically overt bleed that did not meet the criteria of a major bleed but either lead to hospital admission and/or a physician guided medical or surgical treatment and/or a change in antithrombotic therapy (including interruption or discontinuation of study drug).		 6 month treatment period + 2 week post treatment follow up Yes
Secondary Composite of Cardiovascular Death (CVD) With Non Fatal Myocardial Infarction (MI) and Non Haemorrhagic Stroke and All Cause Death (ACD), Non Fatal MI, Severe Recurrent Ischaemia (SRI) and Non Haemorrhagic Stroke During Six Months Treatment Number of Participants with Composite of Cardiovascular death (CVD) with non fatal myocardial infarction (MI) and non haemorrhagic stroke and All cause death (ACD), non fatal MI, severe recurrent ischaemia (SRI) and non haemorrhagic stroke during six months treatment 6 month treatment period + 2 week post treatment follow up No
Secondary Individual Occurrence of Death (Cardiovascular and All-cause), Non-fatal MI, Severe Recurrent Ischaemia and Non-haemorrhagic Stroke During Six Months of Treatment Number of Participants with individual occurrence of death (cardiovascular and all-cause), non-fatal MI, severe recurrent ischaemia and non-haemorrhagic stroke during six months of treatment. 6 month treatment period + 2 week post treatment follow up No
Secondary Number of Participants With Any Reduction of D-dimer Concentration at 1 week and 4 weeks No
Secondary Change From Baseline in log10 D-dimer After 1 and 4 Weeks Change from baseline in log10 D-dimer concentration after 1 and 4 weeks of dabigatran etexilate treatment compared to placebo. The standard deviation is the geometric standard deviation. Baseline and at 1 week and 4 weeks No
Secondary Number of Participants With Bleeding Events During Total Observation Time International Society Thrombosis and Haemostasis (ISTH) definition of a major bleed, and clinically relevant minor bleed.
A bleeding event was considered as major if it was fatal, was a symptomatic bleeding in a critical area or organ (intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome), or caused a fall in haemoglobin level of =2 g/dL (=1.24 mmol/L), or led to transfusion of =2 units of whole blood or red cells.
All non major bleeding events were classified as minor bleeds; minor bleeds were subdivided in clinically relevant minor bleeds (CRBE) and not clinically relevant minor bleeds. A CRBE was defined as an acute or subacute clinically overt bleed that did not meet the criteria of a major bleed but either lead to hospital admission and/or a physician guided medical or surgical treatment and/or a change in antithrombotic therapy (including interruption or discontinuation of study drug).		 6 month treatment period + 2 week post treatment follow up Yes
Secondary Laboratory Analyses Number of patients with possible clinically significant abnormalities. Clinically significant abnormalities refers to the increase or decrease from baseline. 6 month treatment period + 2 week post treatment follow up No
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