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

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ClinicalTrials.gov Identifier: NCT00621855
Recruitment Status : Completed
First Posted : February 22, 2008
Results First Posted : February 11, 2011
Last Update Posted : March 12, 2014
Sponsor:
Collaborator:
Uppsala University
Information provided by:
Boehringer Ingelheim

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Disease Drug: placebo Drug: dabigatran etexilate Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1878 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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)
Study Start Date : March 2008
Actual Primary Completion Date : October 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Dabigatran etexilate 50mg
twice daily dosing,
 Drug: dabigatran etexilate
capsules, twice daily, 26 weeks treatment
Experimental: Dabigatran etexilate 75mg
twice daily dosing, patients with moderate renal impairment allocated 50mg bid
 Drug: dabigatran etexilate
capsules, twice daily, 26 weeks treatment
Experimental: Dabigatran etexilate 110mg
twice daily dosing, patients with moderate renal impairment allocated 75mg bid
 Drug: dabigatran etexilate
capsules, twice daily, 26 weeks treatment
Experimental: dabigatran etexilate 150mg
twice daily dosing, patients with moderate renal impairment allocated 110mg bid
 Drug: dabigatran etexilate
capsules, twice daily, 26 weeks treatment
Placebo Comparator: placebo
matched placebo
 Drug: placebo
matched placebo


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants Displaying the Composite of Major and Clinically Relevant Minor Bleeding Events During Total Observation Time [ Time Frame: 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 :
  1. 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 ]
    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

  2. 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 ]
    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.

  3. Number of Participants With Any Reduction of D-dimer Concentration [ Time Frame: at 1 week and 4 weeks ]
  4. Change From Baseline in log10 D-dimer After 1 and 4 Weeks [ Time Frame: 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.

  5. Number of Participants With Bleeding Events During Total Observation Time [ Time Frame: 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).


  6. Laboratory Analyses [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00621855


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Uppsala University
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00621855    
Other Study ID Numbers: 1160.67
RE-DEEM ( Other Identifier: OTHER )
2007-004301-99 ( EudraCT Number: EudraCT )
First Posted: February 22, 2008    Key Record Dates
Results First Posted: February 11, 2011
Last Update Posted: March 12, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Dabigatran
 Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants