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

NCT ID: NCT00621855

Last Updated: 2014-03-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1878 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Coronary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Dabigatran etexilate 50mg

twice daily dosing,

Group Type EXPERIMENTAL

dabigatran etexilate

Intervention Type DRUG

capsules, twice daily, 26 weeks treatment

Dabigatran etexilate 75mg

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

Group Type EXPERIMENTAL

dabigatran etexilate

Intervention Type DRUG

capsules, twice daily, 26 weeks treatment

Dabigatran etexilate 110mg

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

Group Type EXPERIMENTAL

dabigatran etexilate

Intervention Type DRUG

capsules, twice daily, 26 weeks treatment

dabigatran etexilate 150mg

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

Group Type EXPERIMENTAL

dabigatran etexilate

Intervention Type DRUG

capsules, twice daily, 26 weeks treatment

placebo

matched placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

matched placebo

Interventions

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placebo

matched placebo

Intervention Type DRUG

dabigatran etexilate

capsules, twice daily, 26 weeks treatment

Intervention Type DRUG

dabigatran etexilate

capsules, twice daily, 26 weeks treatment

Intervention Type DRUG

dabigatran etexilate

capsules, twice daily, 26 weeks treatment

Intervention Type DRUG

dabigatran etexilate

capsules, twice daily, 26 weeks treatment

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University

OTHER

Sponsor Role collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1160.67.42008 Boehringer Ingelheim Investigational Site

Ostrava, , Czechia

Site Status

1160.67.42001 Boehringer Ingelheim Investigational Site

Prague, , Czechia

Site Status

1160.67.42003 Boehringer Ingelheim Investigational Site

Teplice, , Czechia

Site Status

1160.67.42002 Boehringer Ingelheim Investigational Site

Zlín, , Czechia

Site Status

1160.67.10002 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Site Status

1160.67.32008 Boehringer Ingelheim Investigational Site

Bouge/Namur, , Belgium

Site Status

1160.67.32011 Boehringer Ingelheim Investigational Site

Brasschaat, , Belgium

Site Status

1160.67.32005 Boehringer Ingelheim Investigational Site

Edegem, , Belgium

Site Status

1160.67.32002 Boehringer Ingelheim Investigational Site

Genk, , Belgium

Site Status

1160.67.32006 Boehringer Ingelheim Investigational Site

Gilly, , Belgium

Site Status

1160.67.32003 Boehringer Ingelheim Investigational Site

Hasselt, , Belgium

Site Status

1160.67.32001 Boehringer Ingelheim Investigational Site

Leuven, , Belgium

Site Status

1160.67.32004 Boehringer Ingelheim Investigational Site

Tienen, , Belgium

Site Status

1160.67.59007 Boehringer Ingelheim Investigational Site

Burgas, , Bulgaria

Site Status

1160.67.59009 Boehringer Ingelheim Investigational Site

Dimitrovgrad, , Bulgaria

Site Status

1160.67.59003 Boehringer Ingelheim Investigational Site

Pleven, , Bulgaria

Site Status

1160.67.59012 Boehringer Ingelheim Investigational Site

Pleven, , Bulgaria

Site Status

1160.67.59006 Boehringer Ingelheim Investigational Site

Rousse, , Bulgaria

Site Status

1160.67.59001 Boehringer Ingelheim Investigational Site

Sofia, , Bulgaria

Site Status

1160.67.59002 Boehringer Ingelheim Investigational Site

Sofia, , Bulgaria

Site Status

1160.67.59004 Boehringer Ingelheim Investigational Site

Sofia, , Bulgaria

Site Status

1160.67.59005 Boehringer Ingelheim Investigational Site

Sofia, , Bulgaria

Site Status

1160.67.59008 Boehringer Ingelheim Investigational Site

Sofia, , Bulgaria

Site Status

1160.67.59010 Boehringer Ingelheim Investigational Site

Sofia, , Bulgaria

Site Status

1160.67.11009 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Site Status

1160.67.11003 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Site Status

1160.67.11012 Boehringer Ingelheim Investigational Site

Cambridge, Ontario, Canada

Site Status

1160.67.11010 Boehringer Ingelheim Investigational Site

Greater Sudbury, Ontario, Canada

Site Status

1160.67.11020 Boehringer Ingelheim Investigational Site

Greater Sudbury, Ontario, Canada

Site Status

1160.67.11008 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Site Status

1160.67.11018 Boehringer Ingelheim Investigational Site

London, Ontario, Canada

Site Status

1160.67.11017 Boehringer Ingelheim Investigational Site

Mississauga, Ontario, Canada

Site Status

1160.67.11004 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Site Status

1160.67.11016 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Site Status

1160.67.11014 Boehringer Ingelheim Investigational Site

Québec, Quebec, Canada

Site Status

1160.67.11006 Boehringer Ingelheim Investigational Site

Terrebonne, Quebec, Canada

Site Status

1160.67.42007 Boehringer Ingelheim Investigational Site

Hradec Králové, , Czechia

Site Status

1160.67.42005 Boehringer Ingelheim Investigational Site

Litoměřice, , Czechia

Site Status

1160.67.45001 Boehringer Ingelheim Investigational Site

Aarhus C, , Denmark

Site Status

1160.67.45003 Boehringer Ingelheim Investigational Site

Hvidovre, , Denmark

Site Status

1160.67.45002 Boehringer Ingelheim Investigational Site

Odense, , Denmark

Site Status

1160.67.45004 Boehringer Ingelheim Investigational Site

Roskilde, , Denmark

Site Status

1160.67.58001 Boehringer Ingelheim Investigational Site

HUS, , Finland

Site Status

1160.67.58004 Boehringer Ingelheim Investigational Site

Jyväskylä, , Finland

Site Status

1160.67.58003 Boehringer Ingelheim Investigational Site

Kuopio, , Finland

Site Status

1160.67.58002 Boehringer Ingelheim Investigational Site

Pori, , Finland

Site Status

1160.67.3305A Boehringer Ingelheim Investigational Site

Brest, , France

Site Status

1160.67.3305B Boehringer Ingelheim Investigational Site

Brest, , France

Site Status

1160.67.3303A Boehringer Ingelheim Investigational Site

Dijon, , France

Site Status

1160.67.3303B Boehringer Ingelheim Investigational Site

Dijon, , France

Site Status

1160.67.3303C Boehringer Ingelheim Investigational Site

Dijon, , France

Site Status

1160.67.3303D Boehringer Ingelheim Investigational Site

Dijon, , France

Site Status

1160.67.3301A Boehringer Ingelheim Investigational Site

Paris, , France

Site Status

1160.67.95001 Boehringer Ingelheim Investigational Site

Tbilisi, , Georgia

Site Status

1160.67.95002 Boehringer Ingelheim Investigational Site

Tbilisi, , Georgia

Site Status

1160.67.95003 Boehringer Ingelheim Investigational Site

Tbilisi, , Georgia

Site Status

1160.67.95004 Boehringer Ingelheim Investigational Site

Tbilisi, , Georgia

Site Status

1160.67.95005 Boehringer Ingelheim Investigational Site

Tbilisi, , Georgia

Site Status

1160.67.95006 Boehringer Ingelheim Investigational Site

Tbilisi, , Georgia

Site Status

1160.67.49001 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1160.67.49007 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1160.67.49017 Boehringer Ingelheim Investigational Site

Dresden, , Germany

Site Status

1160.67.49006 Boehringer Ingelheim Investigational Site

Hanover, , Germany

Site Status

1160.67.49019 Boehringer Ingelheim Investigational Site

Homburg/Saar, , Germany

Site Status

1160.67.49008 Boehringer Ingelheim Investigational Site

Ludwigshafen am Rhein, , Germany

Site Status

1160.67.49015 Boehringer Ingelheim Investigational Site

Neuss, , Germany

Site Status

1160.67.49004 Boehringer Ingelheim Investigational Site

Rostock, , Germany

Site Status

1160.67.36001 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

Site Status

1160.67.36003 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

Site Status

1160.67.36004 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

Site Status

1160.67.36002 Boehringer Ingelheim Investigational Site

Debrecen, , Hungary

Site Status

1160.67.36007 Boehringer Ingelheim Investigational Site

Kecskemét, , Hungary

Site Status

1160.67.36006 Boehringer Ingelheim Investigational Site

Komárom, , Hungary

Site Status

1160.67.36008 Boehringer Ingelheim Investigational Site

Miskolc, , Hungary

Site Status

1160.67.36009 Boehringer Ingelheim Investigational Site

Mosonmagyaróvár, , Hungary

Site Status

1160.67.36005 Boehringer Ingelheim Investigational Site

Zalaegerszeg, , Hungary

Site Status

1160.67.91004 Boehringer Ingelheim Investigational Site

Amedabad, , India

Site Status

1160.67.91001 Boehringer Ingelheim Investigational Site

Chennai, , India

Site Status

1160.67.91005 Boehringer Ingelheim Investigational Site

Hyderabad, , India

Site Status

1160.67.91007 Boehringer Ingelheim Investigational Site

Lucknow, , India

Site Status

1160.67.91002 Boehringer Ingelheim Investigational Site

Mumbai, , India

Site Status

1160.67.91003 Boehringer Ingelheim Investigational Site

Pune, , India

Site Status

1160.67.91006 Boehringer Ingelheim Investigational Site

Pune, , India

Site Status

1160.67.53001 Boehringer Ingelheim Investigational Site

Dublin, , Ireland

Site Status

1160.67.53002 Boehringer Ingelheim Investigational Site

Dublin, , Ireland

Site Status

1160.67.39006 Boehringer Ingelheim Investigational Site

Ascoli Piceno, , Italy

Site Status

1160.67.39003 Boehringer Ingelheim Investigational Site

Milan, , Italy

Site Status

1160.67.39005 Boehringer Ingelheim Investigational Site

Milan, , Italy

Site Status

1160.67.39001 Boehringer Ingelheim Investigational Site

Parma, , Italy

Site Status

1160.67.39002 Boehringer Ingelheim Investigational Site

S. Maria Capua Vetere (CE), , Italy

Site Status

1160.67.39004 Boehringer Ingelheim Investigational Site

Torino, , Italy

Site Status

1160.67.31003 Boehringer Ingelheim Investigational Site

's-Hertogenbosch, , Netherlands

Site Status

1160.67.31001 Boehringer Ingelheim Investigational Site

Amsterdam, , Netherlands

Site Status

1160.67.31009 Boehringer Ingelheim Investigational Site

Ede, , Netherlands

Site Status

1160.67.31002 Boehringer Ingelheim Investigational Site

Groningen, , Netherlands

Site Status

1160.67.31006 Boehringer Ingelheim Investigational Site

Helmond, , Netherlands

Site Status

1160.67.31011 Boehringer Ingelheim Investigational Site

Hoogeveen, , Netherlands

Site Status

1160.67.31005 Boehringer Ingelheim Investigational Site

Rotterdam, , Netherlands

Site Status

1160.67.31008 Boehringer Ingelheim Investigational Site

Spijkenisse, , Netherlands

Site Status

1160.67.31007 Boehringer Ingelheim Investigational Site

The Hague, , Netherlands

Site Status

1160.67.31004 Boehringer Ingelheim Investigational Site

Tilburg, , Netherlands

Site Status

1160.67.47005 Boehringer Ingelheim Investigational Site

Drammen, , Norway

Site Status

1160.67.47002 Boehringer Ingelheim Investigational Site

Hamar, , Norway

Site Status

1160.67.47003 Boehringer Ingelheim Investigational Site

Haugesund, , Norway

Site Status

1160.67.47004 Boehringer Ingelheim Investigational Site

Hønefoss, , Norway

Site Status

1160.67.47001 Boehringer Ingelheim Investigational Site

Oslo, , Norway

Site Status

1160.67.48003 Boehringer Ingelheim Investigational Site

Bydgoszcz, , Poland

Site Status

1160.67.48006 Boehringer Ingelheim Investigational Site

Bydgoszcz, , Poland

Site Status

1160.67.48004 Boehringer Ingelheim Investigational Site

Gdynia, , Poland

Site Status

1160.67.48005 Boehringer Ingelheim Investigational Site

Inowrocław, , Poland

Site Status

1160.67.48002 Boehringer Ingelheim Investigational Site

Sopot, , Poland

Site Status

1160.67.48001 Boehringer Ingelheim Investigational Site

Warsaw, , Poland

Site Status

1160.67.40006 Boehringer Ingelheim Investigational Site

Baia Mare, , Romania

Site Status

1160.67.40005 Boehringer Ingelheim Investigational Site

Brăila, , Romania

Site Status

1160.67.40001 Boehringer Ingelheim Investigational Site

Bucharest, , Romania

Site Status

1160.67.40003 Boehringer Ingelheim Investigational Site

Bucharest, , Romania

Site Status

1160.67.40004 Boehringer Ingelheim Investigational Site

Bucharest, , Romania

Site Status

1160.67.40002 Boehringer Ingelheim Investigational Site

Oradea, , Romania

Site Status

1160.67.40007 Boehringer Ingelheim Investigational Site

Tg. Mures, , Romania

Site Status

1160.67.70001 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1160.67.70002 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1160.67.70003 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1160.67.70004 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1160.67.70005 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1160.67.70006 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1160.67.70007 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1160.67.70008 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1160.67.70009 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1160.67.70010 Boehringer Ingelheim Investigational Site

Saratov, , Russia

Site Status

1160.67.70011 Boehringer Ingelheim Investigational Site

Saratov, , Russia

Site Status

1160.67.82010 Boehringer Ingelheim Investigational Site

Busan, , South Korea

Site Status

1160.67.82008 Boehringer Ingelheim Investigational Site

Daegu, , South Korea

Site Status

1160.67.82009 Boehringer Ingelheim Investigational Site

Daegu, , South Korea

Site Status

1160.67.82013 Boehringer Ingelheim Investigational Site

Daejeon, , South Korea

Site Status

1160.67.82006 Boehringer Ingelheim Investigational Site

Daejoen, , South Korea

Site Status

1160.67.82007 Boehringer Ingelheim Investigational Site

Incheon, , South Korea

Site Status

1160.67.82012 Boehringer Ingelheim Investigational Site

Jeonju, , South Korea

Site Status

1160.67.82005 Boehringer Ingelheim Investigational Site

Kwangju, , South Korea

Site Status

1160.67.82011 Boehringer Ingelheim Investigational Site

Pusan, , South Korea

Site Status

1160.67.82001 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1160.67.82002 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1160.67.82003 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1160.67.82004 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1160.67.34001 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1160.67.34002 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1160.67.34005 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1160.67.34006 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1160.67.34003 Boehringer Ingelheim Investigational Site

Sabadell (Barcelona), , Spain

Site Status

1160.67.34004 Boehringer Ingelheim Investigational Site

Tarragona, , Spain

Site Status

1160.67.46004 Boehringer Ingelheim Investigational Site

Gothenburg, , Sweden

Site Status

1160.67.46006 Boehringer Ingelheim Investigational Site

Gothenburg, , Sweden

Site Status

1160.67.46007 Boehringer Ingelheim Investigational Site

Malmo, , Sweden

Site Status

1160.67.46005 Boehringer Ingelheim Investigational Site

Motala, , Sweden

Site Status

1160.67.46002 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

Site Status

1160.67.46001 Boehringer Ingelheim Investigational Site

Uppsala, , Sweden

Site Status

1160.67.46003 Boehringer Ingelheim Investigational Site

Vaesteraas, , Sweden

Site Status

1160.67.38002 Boehringer Ingelheim Investigational Site

Ivano-Frankivsk, , Ukraine

Site Status

1160.67.38004 Boehringer Ingelheim Investigational Site

Kharkiv, , Ukraine

Site Status

1160.67.38007 Boehringer Ingelheim Investigational Site

Kharkiv, , Ukraine

Site Status

1160.67.38001 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

1160.67.38003 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

1160.67.38005 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

1160.67.38008 Boehringer Ingelheim Investigational Site

Nikolayev, , Ukraine

Site Status

1160.67.38006 Boehringer Ingelheim Investigational Site

Odesa, , Ukraine

Site Status

1160.67.44003 Boehringer Ingelheim Investigational Site

Brighton, , United Kingdom

Site Status

1160.67.44002 Boehringer Ingelheim Investigational Site

Exeter, , United Kingdom

Site Status

1160.67.44001 Boehringer Ingelheim Investigational Site

Middlesbrough, , United Kingdom

Site Status

Countries

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United States Belgium Bulgaria Canada Czechia Denmark Finland France Georgia Germany Hungary India Ireland Italy Netherlands Norway Poland Romania Russia South Korea Spain Sweden Ukraine United Kingdom

Other Identifiers

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RE-DEEM

Identifier Type: OTHER

Identifier Source: secondary_id

2007-004301-99

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1160.67

Identifier Type: -

Identifier Source: org_study_id

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