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

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:

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Dabigatran Dabigatran etexilate Dabigatran etexilate mesylate

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

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

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
Number of Participants With Any Reduction of D-dimer Concentration [ Time Frame: at 1 week and 4 weeks ] [ Designated as safety issue: No ]

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621855

Show 167 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Uppsala University

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

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:	May 18, 2012
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: 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 May 21, 2013