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Completed

NCT Number: NCT00621855

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

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.

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Key information

Conditions

Coronary Disease Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

1160.67.32008 Boehringer Ingelheim Investigational Site, Bouge/Namur, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with acute coronary syndromes with at least one additional risk factor for cardiovascular complications.

Exclusion criteria

  • Long term treatment with any other oral anticoagulant
  • Severe/disabling stroke within last 6 months
  • Conditions associated with increased bleeding risk
  • Anaemia or thrombocytopenia
  • Severe renal impairment
  • Liver disease
  • Positive pregnancy test

Treatment and study plan

Placebo

Drug

matched placebo

Dabigatran Etexilate

Drug

capsules, twice daily, 26 weeks treatment

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Collaborators

  • Uppsala University

Registry information

Official study 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)

Important dates

Study start
2008
Primary completion
2009
First posted
Feb 22, 2008
Registry last updated
Mar 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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