RE-DEEM Dose Finding Study for Dabigatran Etexilate in Patients With Acute Coronary Syndrome
- Registration Number
- NCT00621855
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1878
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dabigatran etexilate 50mg dabigatran etexilate twice daily dosing, placebo placebo matched placebo dabigatran etexilate 150mg dabigatran etexilate twice daily dosing, patients with moderate renal impairment allocated 110mg bid Dabigatran etexilate 75mg dabigatran etexilate twice daily dosing, patients with moderate renal impairment allocated 50mg bid Dabigatran etexilate 110mg dabigatran etexilate twice daily dosing, patients with moderate renal impairment allocated 75mg bid
- Primary Outcome Measures
Name Time Method Number of Participants Displaying the Composite of Major and Clinically Relevant Minor Bleeding Events During Total Observation Time 6 month treatment period + 2 week post treatment follow up 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).
- Secondary Outcome Measures
Name Time Method Number of Participants With Any Reduction of D-dimer Concentration at 1 week and 4 weeks 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 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
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 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.
Change From Baseline in log10 D-dimer After 1 and 4 Weeks Baseline and at 1 week 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.
Number of Participants With Bleeding Events During Total Observation Time 6 month treatment period + 2 week post treatment follow up 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).Laboratory Analyses 6 month treatment period + 2 week post treatment follow up Number of patients with possible clinically significant abnormalities. Clinically significant abnormalities refers to the increase or decrease from baseline.
Trial Locations
- Locations (167)
1160.67.11020 Boehringer Ingelheim Investigational Site
🇨🇦Sudbury, Ontario, Canada
1160.67.11018 Boehringer Ingelheim Investigational Site
🇨🇦London, Ontario, Canada
1160.67.32003 Boehringer Ingelheim Investigational Site
🇧🇪Hasselt, Belgium
1160.67.11010 Boehringer Ingelheim Investigational Site
🇨🇦Sudbury, Ontario, Canada
1160.67.11012 Boehringer Ingelheim Investigational Site
🇨🇦Cambridge, Ontario, Canada
1160.67.42008 Boehringer Ingelheim Investigational Site
🇨🇿Ostrava, Czech Republic
1160.67.49004 Boehringer Ingelheim Investigational Site
🇩🇪Rostock, Germany
1160.67.42007 Boehringer Ingelheim Investigational Site
🇨🇿Hradec Kralove, Czech Republic
1160.67.42002 Boehringer Ingelheim Investigational Site
🇨🇿Zlin, Czech Republic
1160.67.82003 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1160.67.91004 Boehringer Ingelheim Investigational Site
🇮🇳Amedabad, India
1160.67.46005 Boehringer Ingelheim Investigational Site
🇸🇪Motala, Sweden
1160.67.44001 Boehringer Ingelheim Investigational Site
🇬🇧Middlesbrough, United Kingdom
1160.67.34006 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1160.67.31009 Boehringer Ingelheim Investigational Site
🇳🇱Ede, Netherlands
1160.67.46004 Boehringer Ingelheim Investigational Site
🇸🇪Göteborg, Sweden
1160.67.46006 Boehringer Ingelheim Investigational Site
🇸🇪Göteborg, Sweden
1160.67.46002 Boehringer Ingelheim Investigational Site
🇸🇪Stockholm, Sweden
1160.67.82004 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1160.67.34005 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1160.67.40006 Boehringer Ingelheim Investigational Site
🇷🇴Baia Mare, Romania
1160.67.46003 Boehringer Ingelheim Investigational Site
🇸🇪Vaesteraas, Sweden
1160.67.34001 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1160.67.38004 Boehringer Ingelheim Investigational Site
🇺🇦Kharkov, Ukraine
1160.67.44003 Boehringer Ingelheim Investigational Site
🇬🇧Brighton, United Kingdom
1160.67.34004 Boehringer Ingelheim Investigational Site
🇪🇸Tarragona, Spain
1160.67.38002 Boehringer Ingelheim Investigational Site
🇺🇦Ivano-Frankovsk, Ukraine
1160.67.46007 Boehringer Ingelheim Investigational Site
🇸🇪Malmö, Sweden
1160.67.39006 Boehringer Ingelheim Investigational Site
🇮🇹Ascoli Piceno, Italy
1160.67.39004 Boehringer Ingelheim Investigational Site
🇮🇹Torino, Italy
1160.67.45001 Boehringer Ingelheim Investigational Site
🇩🇰Aarhus C, Denmark
1160.67.45002 Boehringer Ingelheim Investigational Site
🇩🇰Odense, Denmark
1160.67.59002 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
1160.67.59010 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
1160.67.46001 Boehringer Ingelheim Investigational Site
🇸🇪Uppsala, Sweden
1160.67.10002 Boehringer Ingelheim Investigational Site
🇺🇸Clearwater, Florida, United States
1160.67.11017 Boehringer Ingelheim Investigational Site
🇨🇦Mississauga, Ontario, Canada
1160.67.82005 Boehringer Ingelheim Investigational Site
🇰🇷Kwang-Ju, Korea, Republic of
1160.67.34003 Boehringer Ingelheim Investigational Site
🇪🇸Sabadell (Barcelona), Spain
1160.67.32006 Boehringer Ingelheim Investigational Site
🇧🇪Gilly, Belgium
1160.67.59008 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
1160.67.11008 Boehringer Ingelheim Investigational Site
🇨🇦Hamilton, Ontario, Canada
1160.67.11009 Boehringer Ingelheim Investigational Site
🇨🇦Calgary, Alberta, Canada
1160.67.11004 Boehringer Ingelheim Investigational Site
🇨🇦Montreal, Quebec, Canada
1160.67.11014 Boehringer Ingelheim Investigational Site
🇨🇦Quebec, Canada
1160.67.42005 Boehringer Ingelheim Investigational Site
🇨🇿Litomerice, Czech Republic
1160.67.45003 Boehringer Ingelheim Investigational Site
🇩🇰Hvidovre, Denmark
1160.67.42001 Boehringer Ingelheim Investigational Site
🇨🇿Prague, Czech Republic
1160.67.45004 Boehringer Ingelheim Investigational Site
🇩🇰Roskilde, Denmark
1160.67.3305A Boehringer Ingelheim Investigational Site
🇫🇷Brest Cedex, France
1160.67.58004 Boehringer Ingelheim Investigational Site
🇫🇮Jyväskylä, Finland
1160.67.3303A Boehringer Ingelheim Investigational Site
🇫🇷Dijon Cedex, France
1160.67.3303B Boehringer Ingelheim Investigational Site
🇫🇷Dijon Cedex, France
1160.67.3301A Boehringer Ingelheim Investigational Site
🇫🇷Paris, France
1160.67.58003 Boehringer Ingelheim Investigational Site
🇫🇮Kuopio, Finland
1160.67.3305B Boehringer Ingelheim Investigational Site
🇫🇷Brest Cedex, France
1160.67.3303D Boehringer Ingelheim Investigational Site
🇫🇷Dijon Cedex, France
1160.67.95003 Boehringer Ingelheim Investigational Site
🇬🇪Tbilisi, Georgia
1160.67.3303C Boehringer Ingelheim Investigational Site
🇫🇷Dijon Cedex, France
1160.67.95001 Boehringer Ingelheim Investigational Site
🇬🇪Tbilisi, Georgia
1160.67.95002 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, Georgia
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
1160.67.91002 Boehringer Ingelheim Investigational Site
🇮🇳Mumbai, India
1160.67.91003 Boehringer Ingelheim Investigational Site
🇮🇳Pune, India
1160.67.53001 Boehringer Ingelheim Investigational Site
🇮🇪Dublin, Ireland
1160.67.39005 Boehringer Ingelheim Investigational Site
🇮🇹Milano, Italy
1160.67.39003 Boehringer Ingelheim Investigational Site
🇮🇹Milano, Italy
1160.67.82008 Boehringer Ingelheim Investigational Site
🇰🇷Daegu, Korea, Republic of
1160.67.82010 Boehringer Ingelheim Investigational Site
🇰🇷Busan, Korea, Republic of
1160.67.39001 Boehringer Ingelheim Investigational Site
🇮🇹Parma, Italy
1160.67.39002 Boehringer Ingelheim Investigational Site
🇮🇹S. Maria Capua Vetere (CE), Italy
1160.67.82009 Boehringer Ingelheim Investigational Site
🇰🇷Daegu, Korea, Republic of
1160.67.82007 Boehringer Ingelheim Investigational Site
🇰🇷Incheon, 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
1160.67.82001 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1160.67.82011 Boehringer Ingelheim Investigational Site
🇰🇷Pusan, Korea, Republic of
1160.67.82002 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1160.67.70010 Boehringer Ingelheim Investigational Site
🇷🇺Saratov, Russian Federation
1160.67.34002 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1160.67.44002 Boehringer Ingelheim Investigational Site
🇬🇧Exeter, United Kingdom
1160.67.82012 Boehringer Ingelheim Investigational Site
🇰🇷Jeonju, Korea, Republic of
1160.67.32008 Boehringer Ingelheim Investigational Site
🇧🇪Bouge/Namur, Belgium
1160.67.32002 Boehringer Ingelheim Investigational Site
🇧🇪Genk, Belgium
1160.67.59009 Boehringer Ingelheim Investigational Site
🇧🇬Dimitrovgrad, Bulgaria
1160.67.59012 Boehringer Ingelheim Investigational Site
🇧🇬Pleven, Bulgaria
1160.67.32005 Boehringer Ingelheim Investigational Site
🇧🇪Edegem, Belgium
1160.67.59007 Boehringer Ingelheim Investigational Site
🇧🇬Bourgas, Bulgaria
1160.67.59006 Boehringer Ingelheim Investigational Site
🇧🇬Rousse, Bulgaria
1160.67.59004 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
1160.67.58002 Boehringer Ingelheim Investigational Site
🇫🇮Pori, Finland
1160.67.32011 Boehringer Ingelheim Investigational Site
🇧🇪Brasschaat, Belgium
1160.67.59001 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
1160.67.59005 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
1160.67.11016 Boehringer Ingelheim Investigational Site
🇨🇦Montreal, Quebec, Canada
1160.67.31007 Boehringer Ingelheim Investigational Site
🇳🇱Den Haag, Netherlands
1160.67.47005 Boehringer Ingelheim Investigational Site
🇳🇴Drammen, Norway
1160.67.47003 Boehringer Ingelheim Investigational Site
🇳🇴Haugesund, Norway
1160.67.48003 Boehringer Ingelheim Investigational Site
🇵🇱Bydgoszcz, Poland
1160.67.48006 Boehringer Ingelheim Investigational Site
🇵🇱Bydgoszcz, Poland
1160.67.36003 Boehringer Ingelheim Investigational Site
🇭🇺Budapest, Hungary
1160.67.70002 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1160.67.70007 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1160.67.32001 Boehringer Ingelheim Investigational Site
🇧🇪Leuven, Belgium
1160.67.32004 Boehringer Ingelheim Investigational Site
🇧🇪Tienen, Belgium
1160.67.59003 Boehringer Ingelheim Investigational Site
🇧🇬Pleven, Bulgaria
1160.67.36008 Boehringer Ingelheim Investigational Site
🇭🇺Miskolc, Hungary
1160.67.91001 Boehringer Ingelheim Investigational Site
🇮🇳Chennai, India
1160.67.91006 Boehringer Ingelheim Investigational Site
🇮🇳Pune, India
1160.67.31002 Boehringer Ingelheim Investigational Site
🇳🇱Groningen, Netherlands
1160.67.47002 Boehringer Ingelheim Investigational Site
🇳🇴Hamar, Norway
1160.67.47001 Boehringer Ingelheim Investigational Site
🇳🇴Oslo, Norway
1160.67.48004 Boehringer Ingelheim Investigational Site
🇵🇱Gdynia, Poland
1160.67.40001 Boehringer Ingelheim Investigational Site
🇷🇴Bucharest, Romania
1160.67.70011 Boehringer Ingelheim Investigational Site
🇷🇺Saratov, Russian Federation
1160.67.38007 Boehringer Ingelheim Investigational Site
🇺🇦Kharkov, Ukraine
1160.67.38003 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
1160.67.11003 Boehringer Ingelheim Investigational Site
🇨🇦Vancouver, British Columbia, Canada
1160.67.70006 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1160.67.36006 Boehringer Ingelheim Investigational Site
🇭🇺Komarom, Hungary
1160.67.91005 Boehringer Ingelheim Investigational Site
🇮🇳Hyderabad, India
1160.67.53002 Boehringer Ingelheim Investigational Site
🇮🇪Dublin, Ireland
1160.67.31001 Boehringer Ingelheim Investigational Site
🇳🇱Amsterdam, Netherlands
1160.67.31005 Boehringer Ingelheim Investigational Site
🇳🇱Rotterdam, Netherlands
1160.67.48005 Boehringer Ingelheim Investigational Site
🇵🇱Inowroclaw, Poland
1160.67.48001 Boehringer Ingelheim Investigational Site
🇵🇱Warsaw, Poland
1160.67.40004 Boehringer Ingelheim Investigational Site
🇷🇴Bucharest, Romania
1160.67.40007 Boehringer Ingelheim Investigational Site
🇷🇴Tg. Mures, Romania
1160.67.70005 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1160.67.42003 Boehringer Ingelheim Investigational Site
🇨🇿Teplice, Czech Republic
1160.67.58001 Boehringer Ingelheim Investigational Site
🇫🇮HUS, Finland
1160.67.36005 Boehringer Ingelheim Investigational Site
🇭🇺Zalaegerszeg, Hungary
1160.67.91007 Boehringer Ingelheim Investigational Site
🇮🇳Lucknow, India
1160.67.31003 Boehringer Ingelheim Investigational Site
🇳🇱Den Bosch, Netherlands
1160.67.31008 Boehringer Ingelheim Investigational Site
🇳🇱Spijkenisse, Netherlands
1160.67.47004 Boehringer Ingelheim Investigational Site
🇳🇴Hønefoss, Norway
1160.67.40005 Boehringer Ingelheim Investigational Site
🇷🇴Braila, Romania
1160.67.38008 Boehringer Ingelheim Investigational Site
🇺🇦Nikolayev, Ukraine
1160.67.38006 Boehringer Ingelheim Investigational Site
🇺🇦Odessa, Ukraine
1160.67.11006 Boehringer Ingelheim Investigational Site
🇨🇦Terrebonne, Quebec, Canada
1160.67.70001 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1160.67.70003 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1160.67.36002 Boehringer Ingelheim Investigational Site
🇭🇺Debrecen, Hungary
1160.67.36007 Boehringer Ingelheim Investigational Site
🇭🇺Kecskemet, Hungary
1160.67.36009 Boehringer Ingelheim Investigational Site
🇭🇺Mosonmagyarovar, Hungary
1160.67.31006 Boehringer Ingelheim Investigational Site
🇳🇱Helmond, Netherlands
1160.67.31011 Boehringer Ingelheim Investigational Site
🇳🇱Hoogeveen, Netherlands
1160.67.31004 Boehringer Ingelheim Investigational Site
🇳🇱Tilburg, Netherlands
1160.67.48002 Boehringer Ingelheim Investigational Site
🇵🇱Sopot, Poland
1160.67.40003 Boehringer Ingelheim Investigational Site
🇷🇴Bucharest, Romania
1160.67.40002 Boehringer Ingelheim Investigational Site
🇷🇴Oradea, Romania
1160.67.70008 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1160.67.38001 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
1160.67.36001 Boehringer Ingelheim Investigational Site
🇭🇺Budapest, Hungary
1160.67.36004 Boehringer Ingelheim Investigational Site
🇭🇺Budapest, Hungary
1160.67.70004 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1160.67.70009 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1160.67.38005 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine