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)
1160.67.10002 Boehringer Ingelheim Investigational Site
🇺🇸Clearwater, Florida, United States
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, Belgium
1160.67.59007 Boehringer Ingelheim Investigational Site
🇧🇬Bourgas, Bulgaria
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