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RE-DEEM Dose Finding Study for Dabigatran Etexilate in Patients With Acute Coronary Syndrome
This study is ongoing, but not recruiting participants.
First Received: February 13, 2008   Last Updated: August 20, 2009   History of Changes
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00621855
  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 b.i.d, 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: Dabigatran etexilate
Drug: Placebo
 Phase II

Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety Study
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:

MedlinePlus related topics: Coronary Artery Disease
Drug Information available for: Dabigatran Dabigatran etexilate
U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • The composite of major and clinically relevant minor bleeding events during six months of treatment [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Indicators of efficacy and composite of cardiovascular death or all cause death with: non fatal MI and non haemorrhagic stroke during six months of treatment. [ Time Frame: 1 week, 4 weeks (biomarkers), 6 months ]

Estimated Enrollment: 1878
Study Start Date: March 2008
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
  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 e.g. major surgery (including CABG) in last month or during course of study
  4. History of bleeding
  5. Haemorrhagic disorders
  6. Anaemia or thrombocytopenia
  7. Severe renal impairment
  8. Liver disease
  9. 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 Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 1160.67, RE-DEEM EUDRACT2007-004301-99
Study First Received: February 13, 2008
Last Updated: August 20, 2009
ClinicalTrials.gov Identifier: NCT00621855     History of Changes
Health Authority: Belgium: Federal Agency for Medicines and Health Products;   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: National Agency for Medicines;   France: Afssaps - French Health Products Safety Agency;   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

Study placed in the following topic categories:
Arterial Occlusive Diseases
Coronary Disease
Signs and Symptoms
Heart Diseases
Aspirin
Clopidogrel
 Myocardial Ischemia
Acute Coronary Syndrome
Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Acute Coronary Syndrome
 Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on September 04, 2009



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