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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,878
matched placebo
capsules, twice daily, 26 weeks treatment
capsules, twice daily, 26 weeks treatment
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).
Time frame: 6 month treatment period + 2 week post treatment follow up
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
Time frame: 6 month treatment period + 2 week post treatment follow up
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.
Time frame: 6 month treatment period + 2 week post treatment follow up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
capsules, twice daily, 26 weeks treatment
capsules, twice daily, 26 weeks treatment
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
Burgas, Bulgaria
...and 157 more locations
Number of Participants With Any Reduction of D-dimer Concentration
Time frame: at 1 week and 4 weeks
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.
Time frame: Baseline and at 1 week and 4 weeks
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).
Time frame: 6 month treatment period + 2 week post treatment follow up
Laboratory Analyses
Number of patients with possible clinically significant abnormalities. Clinically significant abnormalities refers to the increase or decrease from baseline.
Time frame: 6 month treatment period + 2 week post treatment follow up