Coronary DiseasePhase 2NCT00621855

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

A Phase 2 study testing dabigatran etexilate in people with Coronary Disease, run by Boehringer Ingelheim at 167 sites in 24 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Disease
What is being tested?: dabigatran etexilate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,878 participants
Where: 167 sitesin 24 countries
Study dates: Mar 2008to Oct 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

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

Trial locations and contacts

167 sites in 24 countries.

Country

City, postcode or hospital

167 sites in 24 countries

South Korea13 sites

1160.67.82010 Boehringer Ingelheim Investigational Site
Busan
1160.67.82008 Boehringer Ingelheim Investigational Site
Daegu
1160.67.82009 Boehringer Ingelheim Investigational Site
Daegu
1160.67.82013 Boehringer Ingelheim Investigational Site
Daejeon
1160.67.82006 Boehringer Ingelheim Investigational Site
Daejoen
1160.67.82007 Boehringer Ingelheim Investigational Site
Incheon
1160.67.82012 Boehringer Ingelheim Investigational Site
Jeonju
1160.67.82005 Boehringer Ingelheim Investigational Site
Kwangju
1160.67.82011 Boehringer Ingelheim Investigational Site
Pusan
1160.67.82001 Boehringer Ingelheim Investigational Site
Seoul
1160.67.82002 Boehringer Ingelheim Investigational Site
Seoul
1160.67.82003 Boehringer Ingelheim Investigational Site
Seoul
1160.67.82004 Boehringer Ingelheim Investigational Site
Seoul

Other trials in South Korea

Canada12 sites

1160.67.11009 Boehringer Ingelheim Investigational Site
Calgary, Alberta
1160.67.11012 Boehringer Ingelheim Investigational Site
Cambridge, Ontario
1160.67.11010 Boehringer Ingelheim Investigational Site
Greater Sudbury, Ontario
1160.67.11020 Boehringer Ingelheim Investigational Site
Greater Sudbury, Ontario
1160.67.11008 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
1160.67.11018 Boehringer Ingelheim Investigational Site
London, Ontario
1160.67.11017 Boehringer Ingelheim Investigational Site
Mississauga, Ontario
1160.67.11004 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1160.67.11016 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1160.67.11014 Boehringer Ingelheim Investigational Site
Québec, Quebec
1160.67.11006 Boehringer Ingelheim Investigational Site
Terrebonne, Quebec
1160.67.11003 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia

Other trials in Canada

Bulgaria11 sites

1160.67.59007 Boehringer Ingelheim Investigational Site
Burgas
1160.67.59009 Boehringer Ingelheim Investigational Site
Dimitrovgrad
1160.67.59003 Boehringer Ingelheim Investigational Site
Pleven
1160.67.59012 Boehringer Ingelheim Investigational Site
Pleven
1160.67.59006 Boehringer Ingelheim Investigational Site
Rousse
1160.67.59001 Boehringer Ingelheim Investigational Site
Sofia
1160.67.59002 Boehringer Ingelheim Investigational Site
Sofia
1160.67.59004 Boehringer Ingelheim Investigational Site
Sofia
1160.67.59005 Boehringer Ingelheim Investigational Site
Sofia
1160.67.59008 Boehringer Ingelheim Investigational Site
Sofia
1160.67.59010 Boehringer Ingelheim Investigational Site
Sofia

Other trials in Bulgaria

Russia11 sites

1160.67.70001 Boehringer Ingelheim Investigational Site
Moscow
1160.67.70002 Boehringer Ingelheim Investigational Site
Moscow
1160.67.70003 Boehringer Ingelheim Investigational Site
Moscow
1160.67.70004 Boehringer Ingelheim Investigational Site
Moscow
1160.67.70005 Boehringer Ingelheim Investigational Site
Moscow
1160.67.70006 Boehringer Ingelheim Investigational Site
Moscow
1160.67.70007 Boehringer Ingelheim Investigational Site
Moscow
1160.67.70008 Boehringer Ingelheim Investigational Site
Saint Petersburg
1160.67.70009 Boehringer Ingelheim Investigational Site
Saint Petersburg
1160.67.70010 Boehringer Ingelheim Investigational Site
Saratov
1160.67.70011 Boehringer Ingelheim Investigational Site
Saratov

Other trials in Russia

Netherlands10 sites

1160.67.31003 Boehringer Ingelheim Investigational Site
's-Hertogenbosch
1160.67.31001 Boehringer Ingelheim Investigational Site
Amsterdam
1160.67.31009 Boehringer Ingelheim Investigational Site
Ede
1160.67.31002 Boehringer Ingelheim Investigational Site
Groningen
1160.67.31006 Boehringer Ingelheim Investigational Site
Helmond
1160.67.31011 Boehringer Ingelheim Investigational Site
Hoogeveen
1160.67.31005 Boehringer Ingelheim Investigational Site
Rotterdam
1160.67.31008 Boehringer Ingelheim Investigational Site
Spijkenisse
1160.67.31007 Boehringer Ingelheim Investigational Site
The Hague
1160.67.31004 Boehringer Ingelheim Investigational Site
Tilburg

Other trials in Netherlands

Hungary9 sites

1160.67.36001 Boehringer Ingelheim Investigational Site
Budapest
1160.67.36003 Boehringer Ingelheim Investigational Site
Budapest
1160.67.36004 Boehringer Ingelheim Investigational Site
Budapest
1160.67.36002 Boehringer Ingelheim Investigational Site
Debrecen
1160.67.36007 Boehringer Ingelheim Investigational Site
Kecskemét
1160.67.36006 Boehringer Ingelheim Investigational Site
Komárom
1160.67.36008 Boehringer Ingelheim Investigational Site
Miskolc
1160.67.36009 Boehringer Ingelheim Investigational Site
Mosonmagyaróvár
1160.67.36005 Boehringer Ingelheim Investigational Site
Zalaegerszeg

Other trials in Hungary

Belgium8 sites

1160.67.32008 Boehringer Ingelheim Investigational Site
Bouge/Namur
1160.67.32011 Boehringer Ingelheim Investigational Site
Brasschaat
1160.67.32005 Boehringer Ingelheim Investigational Site
Edegem
1160.67.32002 Boehringer Ingelheim Investigational Site
Genk
1160.67.32006 Boehringer Ingelheim Investigational Site
Gilly
1160.67.32003 Boehringer Ingelheim Investigational Site
Hasselt
1160.67.32001 Boehringer Ingelheim Investigational Site
Leuven
1160.67.32004 Boehringer Ingelheim Investigational Site
Tienen

Other trials in Belgium

Germany8 sites

1160.67.49001 Boehringer Ingelheim Investigational Site
Berlin
1160.67.49007 Boehringer Ingelheim Investigational Site
Berlin
1160.67.49017 Boehringer Ingelheim Investigational Site
Dresden
1160.67.49006 Boehringer Ingelheim Investigational Site
Hanover
1160.67.49019 Boehringer Ingelheim Investigational Site
Homburg/Saar
1160.67.49008 Boehringer Ingelheim Investigational Site
Ludwigshafen am Rhein
1160.67.49015 Boehringer Ingelheim Investigational Site
Neuss
1160.67.49004 Boehringer Ingelheim Investigational Site
Rostock

Other trials in Germany

Ukraine8 sites

1160.67.38002 Boehringer Ingelheim Investigational Site
Ivano-Frankivsk
1160.67.38004 Boehringer Ingelheim Investigational Site
Kharkiv
1160.67.38007 Boehringer Ingelheim Investigational Site
Kharkiv
1160.67.38001 Boehringer Ingelheim Investigational Site
Kiev
1160.67.38003 Boehringer Ingelheim Investigational Site
Kiev
1160.67.38005 Boehringer Ingelheim Investigational Site
Kiev
1160.67.38008 Boehringer Ingelheim Investigational Site
Nikolayev
1160.67.38006 Boehringer Ingelheim Investigational Site
Odesa

Other trials in Ukraine

France7 sites

1160.67.3305A Boehringer Ingelheim Investigational Site
Brest
1160.67.3305B Boehringer Ingelheim Investigational Site
Brest
1160.67.3303A Boehringer Ingelheim Investigational Site
Dijon
1160.67.3303B Boehringer Ingelheim Investigational Site
Dijon
1160.67.3303C Boehringer Ingelheim Investigational Site
Dijon
1160.67.3303D Boehringer Ingelheim Investigational Site
Dijon
1160.67.3301A Boehringer Ingelheim Investigational Site
Paris

Other trials in France

India7 sites

1160.67.91004 Boehringer Ingelheim Investigational Site
Amedabad
1160.67.91001 Boehringer Ingelheim Investigational Site
Chennai
1160.67.91005 Boehringer Ingelheim Investigational Site
Hyderabad
1160.67.91007 Boehringer Ingelheim Investigational Site
Lucknow
1160.67.91002 Boehringer Ingelheim Investigational Site
Mumbai
1160.67.91003 Boehringer Ingelheim Investigational Site
Pune
1160.67.91006 Boehringer Ingelheim Investigational Site
Pune

Other trials in India

Romania7 sites

1160.67.40006 Boehringer Ingelheim Investigational Site
Baia Mare
1160.67.40005 Boehringer Ingelheim Investigational Site
Brăila
1160.67.40001 Boehringer Ingelheim Investigational Site
Bucharest
1160.67.40003 Boehringer Ingelheim Investigational Site
Bucharest
1160.67.40004 Boehringer Ingelheim Investigational Site
Bucharest
1160.67.40002 Boehringer Ingelheim Investigational Site
Oradea
1160.67.40007 Boehringer Ingelheim Investigational Site
Tg. Mures

Other trials in Romania

Sweden7 sites

1160.67.46004 Boehringer Ingelheim Investigational Site
Gothenburg
1160.67.46006 Boehringer Ingelheim Investigational Site
Gothenburg
1160.67.46007 Boehringer Ingelheim Investigational Site
Malmö
1160.67.46005 Boehringer Ingelheim Investigational Site
Motala
1160.67.46002 Boehringer Ingelheim Investigational Site
Stockholm
1160.67.46001 Boehringer Ingelheim Investigational Site
Uppsala
1160.67.46003 Boehringer Ingelheim Investigational Site
Vaesteraas

Other trials in Sweden

Czechia6 sites

1160.67.42007 Boehringer Ingelheim Investigational Site
Hradec Králové
1160.67.42005 Boehringer Ingelheim Investigational Site
Litoměřice
1160.67.42008 Boehringer Ingelheim Investigational Site
Ostrava
1160.67.42001 Boehringer Ingelheim Investigational Site
Prague
1160.67.42003 Boehringer Ingelheim Investigational Site
Teplice
1160.67.42002 Boehringer Ingelheim Investigational Site
Zlín

Other trials in Czechia

Georgia6 sites

1160.67.95001 Boehringer Ingelheim Investigational Site
Tbilisi
1160.67.95002 Boehringer Ingelheim Investigational Site
Tbilisi
1160.67.95003 Boehringer Ingelheim Investigational Site
Tbilisi
1160.67.95004 Boehringer Ingelheim Investigational Site
Tbilisi
1160.67.95005 Boehringer Ingelheim Investigational Site
Tbilisi
1160.67.95006 Boehringer Ingelheim Investigational Site
Tbilisi

Other trials in Georgia

Italy6 sites

1160.67.39006 Boehringer Ingelheim Investigational Site
Ascoli Piceno
1160.67.39003 Boehringer Ingelheim Investigational Site
Milan
1160.67.39005 Boehringer Ingelheim Investigational Site
Milan
1160.67.39001 Boehringer Ingelheim Investigational Site
Parma
1160.67.39002 Boehringer Ingelheim Investigational Site
S. Maria Capua Vetere (CE)
1160.67.39004 Boehringer Ingelheim Investigational Site
Torino

Other trials in Italy

Poland6 sites

1160.67.48003 Boehringer Ingelheim Investigational Site
Bydgoszcz
1160.67.48006 Boehringer Ingelheim Investigational Site
Bydgoszcz
1160.67.48004 Boehringer Ingelheim Investigational Site
Gdynia
1160.67.48005 Boehringer Ingelheim Investigational Site
Inowrocław
1160.67.48002 Boehringer Ingelheim Investigational Site
Sopot
1160.67.48001 Boehringer Ingelheim Investigational Site
Warsaw

Other trials in Poland

Spain6 sites

1160.67.34001 Boehringer Ingelheim Investigational Site
Barcelona
1160.67.34002 Boehringer Ingelheim Investigational Site
Barcelona
1160.67.34005 Boehringer Ingelheim Investigational Site
Madrid
1160.67.34006 Boehringer Ingelheim Investigational Site
Madrid
1160.67.34003 Boehringer Ingelheim Investigational Site
Sabadell (Barcelona)
1160.67.34004 Boehringer Ingelheim Investigational Site
Tarragona

Other trials in Spain

Norway5 sites

1160.67.47005 Boehringer Ingelheim Investigational Site
Drammen
1160.67.47002 Boehringer Ingelheim Investigational Site
Hamar
1160.67.47003 Boehringer Ingelheim Investigational Site
Haugesund
1160.67.47004 Boehringer Ingelheim Investigational Site
Hønefoss
1160.67.47001 Boehringer Ingelheim Investigational Site
Oslo

Other trials in Norway

Denmark4 sites

1160.67.45001 Boehringer Ingelheim Investigational Site
Aarhus C
1160.67.45003 Boehringer Ingelheim Investigational Site
Hvidovre
1160.67.45002 Boehringer Ingelheim Investigational Site
Odense
1160.67.45004 Boehringer Ingelheim Investigational Site
Roskilde

Other trials in Denmark

Finland4 sites

1160.67.58001 Boehringer Ingelheim Investigational Site
HUS
1160.67.58004 Boehringer Ingelheim Investigational Site
Jyväskylä
1160.67.58003 Boehringer Ingelheim Investigational Site
Kuopio
1160.67.58002 Boehringer Ingelheim Investigational Site
Pori

Other trials in Finland

United Kingdom3 sites

1160.67.44003 Boehringer Ingelheim Investigational Site
Brighton
1160.67.44002 Boehringer Ingelheim Investigational Site
Exeter
1160.67.44001 Boehringer Ingelheim Investigational Site
Middlesbrough

Other trials in United Kingdom

Ireland2 sites

1160.67.53001 Boehringer Ingelheim Investigational Site
Dublin
1160.67.53002 Boehringer Ingelheim Investigational Site
Dublin

Other trials in Ireland

United States1 site

1160.67.10002 Boehringer Ingelheim Investigational Site
Clearwater, Florida

Other trials in United States

About this 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)

Conditions: Coronary Disease
Being tested: placebo, dabigatran etexilate
Medical subject headings: Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

placeboDrug
matched placebo
dabigatran etexilateDrug
capsules, twice daily, 26 weeks treatment
dabigatran etexilateDrug
capsules, twice daily, 26 weeks treatment
dabigatran etexilateDrug
capsules, twice daily, 26 weeks treatment
dabigatran etexilateDrug
capsules, twice daily, 26 weeks treatment

Study groups in NCT00621855
Study group	Role	What they receive
Dabigatran etexilate 50mg	Experimental	twice daily dosing, Receives: Drug: dabigatran etexilate
Dabigatran etexilate 75mg	Experimental	twice daily dosing, patients with moderate renal impairment allocated 50mg bid Receives: Drug: dabigatran etexilate
Dabigatran etexilate 110mg	Experimental	twice daily dosing, patients with moderate renal impairment allocated 75mg bid Receives: Drug: dabigatran etexilate
dabigatran etexilate 150mg	Experimental	twice daily dosing, patients with moderate renal impairment allocated 110mg bid Receives: Drug: dabigatran etexilate
placebo	Placebo comparator	matched placebo Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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
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
Measured: 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
Number of Participants with individual occurrence of death (cardiovascular and all-cause), non-fatal MI, severe recurrent ischaemia and non-haemorrhagic stroke during six months of treatment.
Measured: 6 month treatment period + 2 week post treatment follow up
Number of Participants With Any Reduction of D-dimer Concentration
Measured: at 1 week and 4 weeks
Change From Baseline in log10 D-dimer After 1 and 4 Weeks
Change from baseline in log10 D-dimer concentration after 1 and 4 weeks of dabigatran etexilate treatment compared to placebo. The standard deviation is the geometric standard deviation.
Measured: Baseline and at 1 week and 4 weeks
Number of Participants With 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 (CRBE) 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).
Measured: 6 month treatment period + 2 week post treatment follow up
Laboratory Analyses
Number of patients with possible clinically significant abnormalities. Clinically significant abnormalities refers to the increase or decrease from baseline.
Measured: 6 month treatment period + 2 week post treatment follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2008Oct 2009

First posted22 Feb 2008 (estimated)
Study startMar 2008
Primary completionOct 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Coronary DiseaseStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 1,878 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00621855
Sponsor's protocol ID: 1160.67
Other IDs: RE-DEEM, 2007-004301-99
Status last verified: Feb 2014
First submitted: 13 Feb 2008
Last updated: 12 Mar 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT00621855
Acronym / sponsor ID: 1160.67
Conditions: Coronary Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,878 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Uppsala University
Study start: Mar 2008
Primary completion: Oct 2009 (actual)
First posted: 22 Feb 2008 (estimated)
Results: Posted 11 Feb 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 5

Arm	Type	Receives
Dabigatran etexilate 50mg	Experimental	Drug: dabigatran etexilatetwice daily dosing,
Dabigatran etexilate 75mg	Experimental	Drug: dabigatran etexilatetwice daily dosing, patients with moderate renal impairment allocated 50mg bid
Dabigatran etexilate 110mg	Experimental	Drug: dabigatran etexilatetwice daily dosing, patients with moderate renal impairment allocated 75mg bid
dabigatran etexilate 150mg	Experimental	Drug: dabigatran etexilatetwice daily dosing, patients with moderate renal impairment allocated 110mg bid
placebo	Placebo comparator	Drug: placebomatched placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
placebomatched placebo	Drug	placebo
dabigatran etexilatecapsules, twice daily, 26 weeks treatment	Drug	Dabigatran etexilate 50mg
dabigatran etexilatecapsules, twice daily, 26 weeks treatment	Drug	Dabigatran etexilate 75mg
dabigatran etexilatecapsules, twice daily, 26 weeks treatment	Drug	Dabigatran etexilate 110mg
dabigatran etexilatecapsules, twice daily, 26 weeks treatment	Drug	dabigatran etexilate 150mg

Primary outcome

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
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 secondary outcomes

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
Individual Occurrence of Death (Cardiovascular and All-cause), Non-fatal MI, Severe Recurrent Ischaemia and Non-haemorrhagic Stroke During Six Months of Treatment
Time frame: 6 month treatment period + 2 week post treatment follow up
Number of Participants With Any Reduction of D-dimer Concentration
Time frame: at 1 week and 4 weeks
Change From Baseline in log10 D-dimer After 1 and 4 Weeks
Time frame: Baseline and at 1 week and 4 weeks
Number of Participants With Bleeding Events During Total Observation Time
Time frame: 6 month treatment period + 2 week post treatment follow up
Laboratory Analyses
Time frame: 6 month treatment period + 2 week post treatment follow up

Results and safety

Results posted to the registry on 11 Feb 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
50mg Dabigatran Etexilate	372	296
75mg Dabigatran Etexilate	371	310
110mg Dabigatran Etexilate	411	330
150mg Dabigatran Etexilate	351	284
Placebo	373	318

Primary outcome: 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. Number. Unit: participants

Measure	50mg Dabigatran Etexilate n = 369	75mg Dabigatran Etexilate n = 368	110mg Dabigatran Etexilate n = 406	150mg Dabigatran Etexilate n = 347	Placebo n = 371
Major and clinically relevant minor bleed events	13	16	32	27	8
No major or clinically relevant minor bleed events	356	352	374	320	363

50mg Dabigatran Etexilate vs 75mg Dabigatran Etexilate vs 110mg Dabigatran Etexilate vs 150mg Dabigatran Etexilate vs Placebo: p <0.001, Cochran-Armitage test for linear trend

Population analysed: Treated set - The treated set includes all patients who received at least one dose of study medication.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 month treatment period + 3 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
50mg Dabigatran Etexilate	33 of 369 (8.9%)	0 of 369 (0%)	Not reported
75mg Dabigatran Etexilate	31 of 368 (8.4%)	0 of 368 (0%)	Not reported
110mg Dabigatran Etexilate	35 of 406 (8.6%)	0 of 406 (0%)	Not reported
150mg Dabigatran Etexilate	21 of 347 (6.1%)	0 of 347 (0%)	Not reported
Placebo	32 of 371 (8.6%)	0 of 371 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

167 sites in 24 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing dabigatran etexilate in people with Coronary Disease, run by Boehringer Ingelheim at 167 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 167 sites in South Korea, Canada, Bulgaria, Russia, Netherlands and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00621855.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2014.