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

This study has been completed.
Sponsor:
Collaborator:
Uppsala University
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00621855
First received: February 13, 2008
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Coronary Disease
Drug: placebo
Drug: dabigatran etexilate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

    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:
  • 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 month treatment period + 2 week post treatment follow up ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Any Reduction of D-dimer Concentration [ Time Frame: at 1 week and 4 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in log10 D-dimer After 1 and 4 Weeks [ Time Frame: Baseline and at 1 week and 4 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 month treatment period + 2 week post treatment follow up ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 6 month treatment period + 2 week post treatment follow up ] [ Designated as safety issue: No ]
    Number of patients with possible clinically significant abnormalities. Clinically significant abnormalities refers to the increase or decrease from baseline.


Enrollment: 1878
Study Start Date: March 2008
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00621855

  Show 167 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Uppsala University
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00621855     History of Changes
Other Study ID Numbers: 1160.67, RE-DEEM, 2007-004301-99
Study First Received: February 13, 2008
Results First Received: November 18, 2010
Last Updated: February 10, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Bulgaria: Bulgarian Drug Agency, BG-1504 Sofia
Canada: Health Canada, Therapeutic Products Directorate
Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10
Denmark: The Danish Medicines Agency
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Georgia: State Regulation Agency of Medical Activity, GE-0160 Tbilisi
Germany: BfArM-Federal Authorities for Drugs and Medical Devices
Great Britain: MHRA
Hungary: National Institute of Pharmacy, H-1051 Budapest
India: Drug Control General of India
Ireland: Irish Medicines Board
Italy: Comitato Etico Unico per la Provincia di Parma - Azienda Ospedaliera di Parma
Korea, Republic of: KOREA Food and Drug Administration (KFDA)
Netherlands: Central Committee on Research Involving Human Subjects (CCMO)
Norway: Norwegian Medicines Agency
Poland: Urzad Rejestracji Produktow Leczniczych, Wyrobow, Medycznych i Produktow Biobojczych, PL-00725 Warsaw
Romania: National Medicines Agency, Bucharest
Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow
Spain: Agencia Española de Medicamentos y Productos Santarios
Sweden: Medical Products Agency
Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)
United States: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014