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

NCT00621855 | Completed Phase 2 Results

• 3 other identifiers: 1160.67RE-DEEM2007-004301-99
• Study Type: interventional
• Target: 1,878
• Locations: 24 countries
• Sites: 167

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.

Conditions

Coronary Disease

Outcome Measures

Primary Outcomes (1)

• Number of Participants Displaying the Composite of Major and Clinically Relevant Minor Bleeding Events During Total Observation Time

  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).

  6 month treatment period + 2 week post treatment follow up

Secondary Outcomes (6)

• 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

  6 month treatment period + 2 week post treatment follow up

• Individual Occurrence of Death (Cardiovascular and All-cause), Non-fatal MI, Severe Recurrent Ischaemia and Non-haemorrhagic Stroke During Six Months of Treatment

  6 month treatment period + 2 week post treatment follow up

• Number of Participants With Any Reduction of D-dimer Concentration

  at 1 week and 4 weeks

• Change From Baseline in log10 D-dimer After 1 and 4 Weeks

  Baseline and at 1 week and 4 weeks

• Number of Participants With Bleeding Events During Total Observation Time

  6 month treatment period + 2 week post treatment follow up

Study Arms (5)

Dabigatran etexilate 50mg

EXPERIMENTAL

twice daily dosing,

Drug: dabigatran etexilate

Dabigatran etexilate 75mg

EXPERIMENTAL

twice daily dosing, patients with moderate renal impairment allocated 50mg bid

Drug: dabigatran etexilate

Dabigatran etexilate 110mg

EXPERIMENTAL

twice daily dosing, patients with moderate renal impairment allocated 75mg bid

Drug: dabigatran etexilate

dabigatran etexilate 150mg

EXPERIMENTAL

twice daily dosing, patients with moderate renal impairment allocated 110mg bid

Drug: dabigatran etexilate

placebo

PLACEBO COMPARATOR

matched placebo

Drug: placebo

Interventions

placebo DRUG

matched placebo

placebo

dabigatran etexilate DRUG

capsules, twice daily, 26 weeks treatment

Dabigatran etexilate 50mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead
• Uppsala University: collaborator

Study Sites (167)

1160.67.10002 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Location

1160.67.32008 Boehringer Ingelheim Investigational Site

Bouge/Namur, Belgium

Location

1160.67.32011 Boehringer Ingelheim Investigational Site

Brasschaat, Belgium

Location

1160.67.32005 Boehringer Ingelheim Investigational Site

Edegem, Belgium

Location

1160.67.32002 Boehringer Ingelheim Investigational Site

Genk, Belgium

Location

1160.67.32006 Boehringer Ingelheim Investigational Site

Gilly, Belgium

Location

1160.67.32003 Boehringer Ingelheim Investigational Site

Hasselt, Belgium

Location

1160.67.32001 Boehringer Ingelheim Investigational Site

Leuven, Belgium

Location

1160.67.32004 Boehringer Ingelheim Investigational Site

Tienen, Belgium

Location

1160.67.59007 Boehringer Ingelheim Investigational Site

Burgas, Bulgaria

Location

1160.67.59009 Boehringer Ingelheim Investigational Site

Dimitrovgrad, Bulgaria

Location

1160.67.59003 Boehringer Ingelheim Investigational Site

Pleven, Bulgaria

Location

1160.67.59012 Boehringer Ingelheim Investigational Site

Pleven, Bulgaria

Location

1160.67.59006 Boehringer Ingelheim Investigational Site

Rousse, Bulgaria

Location

1160.67.59001 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1160.67.59002 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1160.67.59004 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1160.67.59005 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1160.67.59008 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1160.67.59010 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1160.67.11009 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Location

1160.67.11003 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Location

1160.67.11012 Boehringer Ingelheim Investigational Site

Cambridge, Ontario, Canada

Location

1160.67.11010 Boehringer Ingelheim Investigational Site

Greater Sudbury, Ontario, Canada

Location

1160.67.11020 Boehringer Ingelheim Investigational Site

Greater Sudbury, Ontario, Canada

Location

1160.67.11008 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Location

1160.67.11018 Boehringer Ingelheim Investigational Site

London, Ontario, Canada

Location

1160.67.11017 Boehringer Ingelheim Investigational Site

Mississauga, Ontario, Canada

Location

1160.67.11004 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1160.67.11016 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1160.67.11014 Boehringer Ingelheim Investigational Site

Québec, Quebec, Canada

Location

1160.67.11006 Boehringer Ingelheim Investigational Site

Terrebonne, Quebec, Canada

Location

1160.67.42007 Boehringer Ingelheim Investigational Site

Hradec Králové, Czechia

Location

1160.67.42005 Boehringer Ingelheim Investigational Site

Litoměřice, Czechia

Location

1160.67.42008 Boehringer Ingelheim Investigational Site

Ostrava, Czechia

Location

1160.67.42001 Boehringer Ingelheim Investigational Site

Prague, Czechia

Location

1160.67.42003 Boehringer Ingelheim Investigational Site

Teplice, Czechia

Location

1160.67.42002 Boehringer Ingelheim Investigational Site

Zlín, Czechia

Location

1160.67.45001 Boehringer Ingelheim Investigational Site

Aarhus C, Denmark

Location

1160.67.45003 Boehringer Ingelheim Investigational Site

Hvidovre, Denmark

Location

1160.67.45002 Boehringer Ingelheim Investigational Site

Odense, Denmark

Location

1160.67.45004 Boehringer Ingelheim Investigational Site

Roskilde, Denmark

Location

1160.67.58001 Boehringer Ingelheim Investigational Site

HUS, Finland

Location

1160.67.58004 Boehringer Ingelheim Investigational Site

Jyväskylä, Finland

Location

1160.67.58003 Boehringer Ingelheim Investigational Site

Kuopio, Finland

Location

1160.67.58002 Boehringer Ingelheim Investigational Site

Pori, Finland

Location

1160.67.3305A Boehringer Ingelheim Investigational Site

Brest, France

Location

1160.67.3305B Boehringer Ingelheim Investigational Site

Brest, France

Location

1160.67.3303A Boehringer Ingelheim Investigational Site

Dijon, France

Location

1160.67.3303B Boehringer Ingelheim Investigational Site

Dijon, France

Location

1160.67.3303C Boehringer Ingelheim Investigational Site

Dijon, France

Location

1160.67.3303D Boehringer Ingelheim Investigational Site

Dijon, France

Location

1160.67.3301A Boehringer Ingelheim Investigational Site

Paris, France

Location

1160.67.95001 Boehringer Ingelheim Investigational Site

Tbilisi, Georgia

Location

1160.67.95002 Boehringer Ingelheim Investigational Site

Tbilisi, Georgia

Location

1160.67.95003 Boehringer Ingelheim Investigational Site

Tbilisi, Georgia

Location

1160.67.95004 Boehringer Ingelheim Investigational Site

Tbilisi, Georgia

Location

1160.67.95005 Boehringer Ingelheim Investigational Site

Tbilisi, Georgia

Location

1160.67.95006 Boehringer Ingelheim Investigational Site

Tbilisi, Georgia

Location

1160.67.49001 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1160.67.49007 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1160.67.49017 Boehringer Ingelheim Investigational Site

Dresden, Germany

Location

1160.67.49006 Boehringer Ingelheim Investigational Site

Hanover, Germany

Location

1160.67.49019 Boehringer Ingelheim Investigational Site

Homburg/Saar, Germany

Location

1160.67.49008 Boehringer Ingelheim Investigational Site

Ludwigshafen am Rhein, Germany

Location

1160.67.49015 Boehringer Ingelheim Investigational Site

Neuss, Germany

Location

1160.67.49004 Boehringer Ingelheim Investigational Site

Rostock, Germany

Location

1160.67.36001 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

1160.67.36003 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

1160.67.36004 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

1160.67.36002 Boehringer Ingelheim Investigational Site

Debrecen, Hungary

Location

1160.67.36007 Boehringer Ingelheim Investigational Site

Kecskemét, Hungary

Location

1160.67.36006 Boehringer Ingelheim Investigational Site

Komárom, Hungary

Location

1160.67.36008 Boehringer Ingelheim Investigational Site

Miskolc, Hungary

Location

1160.67.36009 Boehringer Ingelheim Investigational Site

Mosonmagyaróvár, Hungary

Location

1160.67.36005 Boehringer Ingelheim Investigational Site

Zalaegerszeg, Hungary

Location

1160.67.91004 Boehringer Ingelheim Investigational Site

Amedabad, India

Location

1160.67.91001 Boehringer Ingelheim Investigational Site

Chennai, India

Location

1160.67.91005 Boehringer Ingelheim Investigational Site

Hyderabad, India

Location

1160.67.91007 Boehringer Ingelheim Investigational Site

Lucknow, India

Location

1160.67.91002 Boehringer Ingelheim Investigational Site

Mumbai, India

Location

1160.67.91003 Boehringer Ingelheim Investigational Site

Pune, India

Location

1160.67.91006 Boehringer Ingelheim Investigational Site

Pune, India

Location

1160.67.53001 Boehringer Ingelheim Investigational Site

Dublin, Ireland

Location

1160.67.53002 Boehringer Ingelheim Investigational Site

Dublin, Ireland

Location

1160.67.39006 Boehringer Ingelheim Investigational Site

Ascoli Piceno, Italy

Location

1160.67.39003 Boehringer Ingelheim Investigational Site

Milan, Italy

Location

1160.67.39005 Boehringer Ingelheim Investigational Site

Milan, Italy

Location

1160.67.39001 Boehringer Ingelheim Investigational Site

Parma, Italy

Location

1160.67.39002 Boehringer Ingelheim Investigational Site

S. Maria Capua Vetere (CE), Italy

Location

1160.67.39004 Boehringer Ingelheim Investigational Site

Torino, Italy

Location

1160.67.31003 Boehringer Ingelheim Investigational Site

's-Hertogenbosch, Netherlands

Location

1160.67.31001 Boehringer Ingelheim Investigational Site

Amsterdam, Netherlands

Location

1160.67.31009 Boehringer Ingelheim Investigational Site

Ede, Netherlands

Location

1160.67.31002 Boehringer Ingelheim Investigational Site

Groningen, Netherlands

Location

1160.67.31006 Boehringer Ingelheim Investigational Site

Helmond, Netherlands

Location

1160.67.31011 Boehringer Ingelheim Investigational Site

Hoogeveen, Netherlands

Location

1160.67.31005 Boehringer Ingelheim Investigational Site

Rotterdam, Netherlands

Location

1160.67.31008 Boehringer Ingelheim Investigational Site

Spijkenisse, Netherlands

Location

1160.67.31007 Boehringer Ingelheim Investigational Site

The Hague, Netherlands

Location

1160.67.31004 Boehringer Ingelheim Investigational Site

Tilburg, Netherlands

Location

1160.67.47005 Boehringer Ingelheim Investigational Site

Drammen, Norway

Location

1160.67.47002 Boehringer Ingelheim Investigational Site

Hamar, Norway

Location

1160.67.47003 Boehringer Ingelheim Investigational Site

Haugesund, Norway

Location

1160.67.47004 Boehringer Ingelheim Investigational Site

Hønefoss, Norway

Location

1160.67.47001 Boehringer Ingelheim Investigational Site

Oslo, Norway

Location

1160.67.48003 Boehringer Ingelheim Investigational Site

Bydgoszcz, Poland

Location

1160.67.48006 Boehringer Ingelheim Investigational Site

Bydgoszcz, Poland

Location

1160.67.48004 Boehringer Ingelheim Investigational Site

Gdynia, Poland

Location

1160.67.48005 Boehringer Ingelheim Investigational Site

Inowrocław, Poland

Location

1160.67.48002 Boehringer Ingelheim Investigational Site

Sopot, Poland

Location

1160.67.48001 Boehringer Ingelheim Investigational Site

Warsaw, Poland

Location

1160.67.40006 Boehringer Ingelheim Investigational Site

Baia Mare, Romania

Location

1160.67.40005 Boehringer Ingelheim Investigational Site

Brăila, Romania

Location

1160.67.40001 Boehringer Ingelheim Investigational Site

Bucharest, Romania

Location

1160.67.40003 Boehringer Ingelheim Investigational Site

Bucharest, Romania

Location

1160.67.40004 Boehringer Ingelheim Investigational Site

Bucharest, Romania

Location

1160.67.40002 Boehringer Ingelheim Investigational Site

Oradea, Romania

Location

1160.67.40007 Boehringer Ingelheim Investigational Site

Tg. Mures, Romania

Location

1160.67.70001 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1160.67.70002 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1160.67.70003 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1160.67.70004 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1160.67.70005 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1160.67.70006 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1160.67.70007 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1160.67.70008 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1160.67.70009 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1160.67.70010 Boehringer Ingelheim Investigational Site

Saratov, Russia

Location

1160.67.70011 Boehringer Ingelheim Investigational Site

Saratov, Russia

Location

1160.67.82010 Boehringer Ingelheim Investigational Site

Busan, South Korea

Location

1160.67.82008 Boehringer Ingelheim Investigational Site

Daegu, South Korea

Location

1160.67.82009 Boehringer Ingelheim Investigational Site

Daegu, South Korea

Location

1160.67.82013 Boehringer Ingelheim Investigational Site

Daejeon, South Korea

Location

1160.67.82006 Boehringer Ingelheim Investigational Site

Daejoen, South Korea

Location

1160.67.82007 Boehringer Ingelheim Investigational Site

Incheon, South Korea

Location

1160.67.82012 Boehringer Ingelheim Investigational Site

Jeonju, South Korea

Location

1160.67.82005 Boehringer Ingelheim Investigational Site

Kwangju, South Korea

Location

1160.67.82011 Boehringer Ingelheim Investigational Site

Pusan, South Korea

Location

1160.67.82001 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1160.67.82002 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1160.67.82003 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1160.67.82004 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1160.67.34001 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1160.67.34002 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1160.67.34005 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1160.67.34006 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1160.67.34003 Boehringer Ingelheim Investigational Site

Sabadell (Barcelona), Spain

Location

1160.67.34004 Boehringer Ingelheim Investigational Site

Tarragona, Spain

Location

1160.67.46004 Boehringer Ingelheim Investigational Site

Gothenburg, Sweden

Location

1160.67.46006 Boehringer Ingelheim Investigational Site

Gothenburg, Sweden

Location

1160.67.46007 Boehringer Ingelheim Investigational Site

Malmo, Sweden

Location

1160.67.46005 Boehringer Ingelheim Investigational Site

Motala, Sweden

Location

1160.67.46002 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

1160.67.46001 Boehringer Ingelheim Investigational Site

Uppsala, Sweden

Location

1160.67.46003 Boehringer Ingelheim Investigational Site

Vaesteraas, Sweden

Location

1160.67.38002 Boehringer Ingelheim Investigational Site

Ivano-Frankivsk, Ukraine

Location

1160.67.38004 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

1160.67.38007 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

1160.67.38001 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1160.67.38003 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1160.67.38005 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1160.67.38008 Boehringer Ingelheim Investigational Site

Nikolayev, Ukraine

Location

1160.67.38006 Boehringer Ingelheim Investigational Site

Odesa, Ukraine

Location

1160.67.44003 Boehringer Ingelheim Investigational Site

Brighton, United Kingdom

Location

1160.67.44002 Boehringer Ingelheim Investigational Site

Exeter, United Kingdom

Location

1160.67.44001 Boehringer Ingelheim Investigational Site

Middlesbrough, United Kingdom

Location

MeSH Terms

Conditions

Coronary Disease

Interventions

Dabigatran

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 13, 2008
• First Posted: February 22, 2008
• Study Start: March 1, 2008
• Primary Completion: October 1, 2009
• Last Updated: March 12, 2014
• Results First Posted: February 11, 2011

Record last verified: 2014-02

Locations

KR (13); NL (10); GB (3); IE (2); ES (6); NO (5); FI (4); IN (7); CZ (6); BU (11); DE (8); PL (6); BE (8); RO (7); SE (7); US (1); HU (9); UA (8); CA (12); FR (7); IT (6); DK (4); RU (11); GE (6)