Clinical trial NCT00621855: RE-DEEM Dose Finding Study for Dabigatran Etexilate in Patients With Acute Coronary Syndrome
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Disease
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Uppsala University
First posted: 2008-02-22
Enrollment: 1878
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of Participants Displaying the Composite of Major and Clinically Relevant Minor Bleeding Events During Total Observation Time
timeFrame: 6 month treatment period + 2 week post treatment follow up
Secondary outcomes:
measure: 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
timeFrame: 6 month treatment period + 2 week post treatment follow up
measure: Individual Occurrence of Death (Cardiovascular and All-cause), Non-fatal MI, Severe Recurrent Ischaemia and Non-haemorrhagic Stroke During Six Months of Treatment
timeFrame: 6 month treatment period + 2 week post treatment follow up
measure: Number of Participants With Any Reduction of D-dimer Concentration
timeFrame: at 1 week and 4 weeks
measure: Change From Baseline in log10 D-dimer After 1 and 4 Weeks
timeFrame: Baseline and at 1 week and 4 weeks
measure: Number of Participants With Bleeding Events During Total Observation Time
timeFrame: 6 month treatment period + 2 week post treatment follow up
measure: Laboratory Analyses
timeFrame: 6 month treatment period + 2 week post treatment follow up
Other outcomes:
Locations:
city: Clearwater
country: United States
facility: 1160.67.10002 Boehringer Ingelheim Investigational Site
state: Florida
city: Bouge/Namur
country: Belgium
facility: 1160.67.32008 Boehringer Ingelheim Investigational Site
city: Brasschaat
country: Belgium
facility: 1160.67.32011 Boehringer Ingelheim Investigational Site
city: Edegem
country: Belgium
facility: 1160.67.32005 Boehringer Ingelheim Investigational Site
city: Genk
country: Belgium
facility: 1160.67.32002 Boehringer Ingelheim Investigational Site
city: Gilly
country: Belgium
facility: 1160.67.32006 Boehringer Ingelheim Investigational Site
city: Hasselt
country: Belgium
facility: 1160.67.32003 Boehringer Ingelheim Investigational Site
city: Leuven
country: Belgium
facility: 1160.67.32001 Boehringer Ingelheim Investigational Site
city: Tienen
country: Belgium
facility: 1160.67.32004 Boehringer Ingelheim Investigational Site
city: Bourgas
country: Bulgaria
facility: 1160.67.59007 Boehringer Ingelheim Investigational Site
city: Dimitrovgrad
country: Bulgaria
facility: 1160.67.59009 Boehringer Ingelheim Investigational Site
city: Pleven
country: Bulgaria
facility: 1160.67.59003 Boehringer Ingelheim Investigational Site
city: Pleven
country: Bulgaria
facility: 1160.67.59012 Boehringer Ingelheim Investigational Site
city: Rousse
country: Bulgaria
facility: 1160.67.59006 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1160.67.59001 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1160.67.59002 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1160.67.59004 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1160.67.59005 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1160.67.59008 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1160.67.59010 Boehringer Ingelheim Investigational Site
city: Calgary
country: Canada
facility: 1160.67.11009 Boehringer Ingelheim Investigational Site
state: Alberta
city: Vancouver
country: Canada
facility: 1160.67.11003 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Cambridge
country: Canada
facility: 1160.67.11012 Boehringer Ingelheim Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: 1160.67.11008 Boehringer Ingelheim Investigational Site
state: Ontario
city: London
country: Canada
facility: 1160.67.11018 Boehringer Ingelheim Investigational Site
state: Ontario
city: Mississauga
country: Canada
facility: 1160.67.11017 Boehringer Ingelheim Investigational Site
state: Ontario
city: Sudbury
country: Canada
facility: 1160.67.11010 Boehringer Ingelheim Investigational Site
state: Ontario
city: Sudbury
country: Canada
facility: 1160.67.11020 Boehringer Ingelheim Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: 1160.67.11004 Boehringer Ingelheim Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: 1160.67.11016 Boehringer Ingelheim Investigational Site
state: Quebec
city: Terrebonne
country: Canada
facility: 1160.67.11006 Boehringer Ingelheim Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: 1160.67.11014 Boehringer Ingelheim Investigational Site
city: Hradec Kralove
country: Czech Republic
facility: 1160.67.42007 Boehringer Ingelheim Investigational Site
city: Litomerice
country: Czech Republic
facility: 1160.67.42005 Boehringer Ingelheim Investigational Site
city: Ostrava
country: Czech Republic
facility: 1160.67.42008 Boehringer Ingelheim Investigational Site
city: Prague
country: Czech Republic
facility: 1160.67.42001 Boehringer Ingelheim Investigational Site
city: Teplice
country: Czech Republic
facility: 1160.67.42003 Boehringer Ingelheim Investigational Site
city: Zlin
country: Czech Republic
facility: 1160.67.42002 Boehringer Ingelheim Investigational Site
city: Aarhus C
country: Denmark
facility: 1160.67.45001 Boehringer Ingelheim Investigational Site
city: Hvidovre
country: Denmark
facility: 1160.67.45003 Boehringer Ingelheim Investigational Site
city: Odense
country: Denmark
facility: 1160.67.45002 Boehringer Ingelheim Investigational Site
city: Roskilde
country: Denmark
facility: 1160.67.45004 Boehringer Ingelheim Investigational Site
city: HUS
country: Finland
facility: 1160.67.58001 Boehringer Ingelheim Investigational Site
city: Jyväskylä
country: Finland
facility: 1160.67.58004 Boehringer Ingelheim Investigational Site
city: Kuopio
country: Finland
facility: 1160.67.58003 Boehringer Ingelheim Investigational Site
city: Pori
country: Finland
facility: 1160.67.58002 Boehringer Ingelheim Investigational Site
city: Brest Cedex
country: France
facility: 1160.67.3305A Boehringer Ingelheim Investigational Site
city: Brest Cedex
country: France
facility: 1160.67.3305B Boehringer Ingelheim Investigational Site
city: Dijon Cedex
country: France
facility: 1160.67.3303A Boehringer Ingelheim Investigational Site
city: Dijon Cedex
country: France
facility: 1160.67.3303B Boehringer Ingelheim Investigational Site
city: Dijon Cedex
country: France
facility: 1160.67.3303C Boehringer Ingelheim Investigational Site
city: Dijon Cedex
country: France
facility: 1160.67.3303D Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: 1160.67.3301A Boehringer Ingelheim Investigational Site
city: Tbilisi
country: Georgia
facility: 1160.67.95001 Boehringer Ingelheim Investigational Site
city: Tbilisi
country: Georgia
facility: 1160.67.95002 Boehringer Ingelheim Investigational Site
city: Tbilisi
country: Georgia
facility: 1160.67.95003 Boehringer Ingelheim Investigational Site
city: Tbilisi
country: Georgia
facility: 1160.67.95004 Boehringer Ingelheim Investigational Site
city: Tbilisi
country: Georgia
facility: 1160.67.95005 Boehringer Ingelheim Investigational Site
city: Tbilisi
country: Georgia
facility: 1160.67.95006 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1160.67.49001 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1160.67.49007 Boehringer Ingelheim Investigational Site
city: Dresden
country: Germany
facility: 1160.67.49017 Boehringer Ingelheim Investigational Site
city: Hannover
country: Germany
facility: 1160.67.49006 Boehringer Ingelheim Investigational Site
city: Homburg/Saar
country: Germany
facility: 1160.67.49019 Boehringer Ingelheim Investigational Site
city: Ludwigshafen am Rhein
country: Germany
facility: 1160.67.49008 Boehringer Ingelheim Investigational Site
city: Neuss
country: Germany
facility: 1160.67.49015 Boehringer Ingelheim Investigational Site
city: Rostock
country: Germany
facility: 1160.67.49004 Boehringer Ingelheim Investigational Site
city: Budapest
country: Hungary
facility: 1160.67.36001 Boehringer Ingelheim Investigational Site
city: Budapest
country: Hungary
facility: 1160.67.36003 Boehringer Ingelheim Investigational Site
city: Budapest
country: Hungary
facility: 1160.67.36004 Boehringer Ingelheim Investigational Site
city: Debrecen
country: Hungary
facility: 1160.67.36002 Boehringer Ingelheim Investigational Site
city: Kecskemet
country: Hungary
facility: 1160.67.36007 Boehringer Ingelheim Investigational Site
city: Komarom
country: Hungary
facility: 1160.67.36006 Boehringer Ingelheim Investigational Site
city: Miskolc
country: Hungary
facility: 1160.67.36008 Boehringer Ingelheim Investigational Site
city: Mosonmagyarovar
country: Hungary
facility: 1160.67.36009 Boehringer Ingelheim Investigational Site
city: Zalaegerszeg
country: Hungary
facility: 1160.67.36005 Boehringer Ingelheim Investigational Site
city: Amedabad
country: India
facility: 1160.67.91004 Boehringer Ingelheim Investigational Site
city: Chennai
country: India
facility: 1160.67.91001 Boehringer Ingelheim Investigational Site
city: Hyderabad
country: India
facility: 1160.67.91005 Boehringer Ingelheim Investigational Site
city: Lucknow
country: India
facility: 1160.67.91007 Boehringer Ingelheim Investigational Site
city: Mumbai
country: India
facility: 1160.67.91002 Boehringer Ingelheim Investigational Site
city: Pune
country: India
facility: 1160.67.91003 Boehringer Ingelheim Investigational Site
city: Pune
country: India
facility: 1160.67.91006 Boehringer Ingelheim Investigational Site
city: Dublin
country: Ireland
facility: 1160.67.53001 Boehringer Ingelheim Investigational Site
city: Dublin
country: Ireland
facility: 1160.67.53002 Boehringer Ingelheim Investigational Site
city: Ascoli Piceno
country: Italy
facility: 1160.67.39006 Boehringer Ingelheim Investigational Site
city: Milano
country: Italy
facility: 1160.67.39003 Boehringer Ingelheim Investigational Site
city: Milano
country: Italy
facility: 1160.67.39005 Boehringer Ingelheim Investigational Site
city: Parma
country: Italy
facility: 1160.67.39001 Boehringer Ingelheim Investigational Site
city: S. Maria Capua Vetere (CE)
country: Italy
facility: 1160.67.39002 Boehringer Ingelheim Investigational Site
city: Torino
country: Italy
facility: 1160.67.39004 Boehringer Ingelheim Investigational Site
city: Busan
country: Korea, Republic of
facility: 1160.67.82010 Boehringer Ingelheim Investigational Site
city: Daegu
country: Korea, Republic of
facility: 1160.67.82008 Boehringer Ingelheim Investigational Site
city: Daegu
country: Korea, Republic of
facility: 1160.67.82009 Boehringer Ingelheim Investigational Site
city: Daejeon
country: Korea, Republic of
facility: 1160.67.82013 Boehringer Ingelheim Investigational Site
city: Daejoen
country: Korea, Republic of
facility: 1160.67.82006 Boehringer Ingelheim Investigational Site
city: Incheon
country: Korea, Republic of
facility: 1160.67.82007 Boehringer Ingelheim Investigational Site
city: Jeonju
country: Korea, Republic of
facility: 1160.67.82012 Boehringer Ingelheim Investigational Site
city: Kwang-Ju
country: Korea, Republic of
facility: 1160.67.82005 Boehringer Ingelheim Investigational Site
city: Pusan
country: Korea, Republic of
facility: 1160.67.82011 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1160.67.82001 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1160.67.82002 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1160.67.82003 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1160.67.82004 Boehringer Ingelheim Investigational Site
city: Amsterdam
country: Netherlands
facility: 1160.67.31001 Boehringer Ingelheim Investigational Site
city: Den Bosch
country: Netherlands
facility: 1160.67.31003 Boehringer Ingelheim Investigational Site
city: Den Haag
country: Netherlands
facility: 1160.67.31007 Boehringer Ingelheim Investigational Site
city: Ede
country: Netherlands
facility: 1160.67.31009 Boehringer Ingelheim Investigational Site
city: Groningen
country: Netherlands
facility: 1160.67.31002 Boehringer Ingelheim Investigational Site
city: Helmond
country: Netherlands
facility: 1160.67.31006 Boehringer Ingelheim Investigational Site
city: Hoogeveen
country: Netherlands
facility: 1160.67.31011 Boehringer Ingelheim Investigational Site
city: Rotterdam
country: Netherlands
facility: 1160.67.31005 Boehringer Ingelheim Investigational Site
city: Spijkenisse
country: Netherlands
facility: 1160.67.31008 Boehringer Ingelheim Investigational Site
city: Tilburg
country: Netherlands
facility: 1160.67.31004 Boehringer Ingelheim Investigational Site
city: Drammen
country: Norway
facility: 1160.67.47005 Boehringer Ingelheim Investigational Site
city: Hamar
country: Norway
facility: 1160.67.47002 Boehringer Ingelheim Investigational Site
city: Haugesund
country: Norway
facility: 1160.67.47003 Boehringer Ingelheim Investigational Site
city: Hønefoss
country: Norway
facility: 1160.67.47004 Boehringer Ingelheim Investigational Site
city: Oslo
country: Norway
facility: 1160.67.47001 Boehringer Ingelheim Investigational Site
city: Bydgoszcz
country: Poland
facility: 1160.67.48003 Boehringer Ingelheim Investigational Site
city: Bydgoszcz
country: Poland
facility: 1160.67.48006 Boehringer Ingelheim Investigational Site
city: Gdynia
country: Poland
facility: 1160.67.48004 Boehringer Ingelheim Investigational Site
city: Inowroclaw
country: Poland
facility: 1160.67.48005 Boehringer Ingelheim Investigational Site
city: Sopot
country: Poland
facility: 1160.67.48002 Boehringer Ingelheim Investigational Site
city: Warsaw
country: Poland
facility: 1160.67.48001 Boehringer Ingelheim Investigational Site
city: Baia Mare
country: Romania
facility: 1160.67.40006 Boehringer Ingelheim Investigational Site
city: Braila
country: Romania
facility: 1160.67.40005 Boehringer Ingelheim Investigational Site
city: Bucharest
country: Romania
facility: 1160.67.40001 Boehringer Ingelheim Investigational Site
city: Bucharest
country: Romania
facility: 1160.67.40003 Boehringer Ingelheim Investigational Site
city: Bucharest
country: Romania
facility: 1160.67.40004 Boehringer Ingelheim Investigational Site
city: Oradea
country: Romania
facility: 1160.67.40002 Boehringer Ingelheim Investigational Site
city: Tg. Mures
country: Romania
facility: 1160.67.40007 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1160.67.70001 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1160.67.70002 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1160.67.70003 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1160.67.70004 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1160.67.70005 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1160.67.70006 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1160.67.70007 Boehringer Ingelheim Investigational Site
city: Saratov
country: Russian Federation
facility: 1160.67.70010 Boehringer Ingelheim Investigational Site
city: Saratov
country: Russian Federation
facility: 1160.67.70011 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1160.67.70008 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1160.67.70009 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1160.67.34001 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1160.67.34002 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1160.67.34005 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1160.67.34006 Boehringer Ingelheim Investigational Site
city: Sabadell (Barcelona)
country: Spain
facility: 1160.67.34003 Boehringer Ingelheim Investigational Site
city: Tarragona
country: Spain
facility: 1160.67.34004 Boehringer Ingelheim Investigational Site
city: Göteborg
country: Sweden
facility: 1160.67.46004 Boehringer Ingelheim Investigational Site
city: Göteborg
country: Sweden
facility: 1160.67.46006 Boehringer Ingelheim Investigational Site
city: Malmö
country: Sweden
facility: 1160.67.46007 Boehringer Ingelheim Investigational Site
city: Motala
country: Sweden
facility: 1160.67.46005 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 1160.67.46002 Boehringer Ingelheim Investigational Site
city: Uppsala
country: Sweden
facility: 1160.67.46001 Boehringer Ingelheim Investigational Site
city: Vaesteraas
country: Sweden
facility: 1160.67.46003 Boehringer Ingelheim Investigational Site
city: Ivano-Frankovsk
country: Ukraine
facility: 1160.67.38002 Boehringer Ingelheim Investigational Site
city: Kharkov
country: Ukraine
facility: 1160.67.38004 Boehringer Ingelheim Investigational Site
city: Kharkov
country: Ukraine
facility: 1160.67.38007 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1160.67.38001 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1160.67.38003 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1160.67.38005 Boehringer Ingelheim Investigational Site
city: Nikolayev
country: Ukraine
facility: 1160.67.38008 Boehringer Ingelheim Investigational Site
city: Odessa
country: Ukraine
facility: 1160.67.38006 Boehringer Ingelheim Investigational Site
city: Brighton
country: United Kingdom
facility: 1160.67.44003 Boehringer Ingelheim Investigational Site
city: Exeter
country: United Kingdom
facility: 1160.67.44002 Boehringer Ingelheim Investigational Site
city: Middlesbrough
country: United Kingdom
facility: 1160.67.44001 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: