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

Primary Purpose

Coronary Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
placebo
dabigatran etexilate
dabigatran etexilate
dabigatran etexilate
dabigatran etexilate
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 1160.67.10002 Boehringer Ingelheim Investigational Site
  • 1160.67.32008 Boehringer Ingelheim Investigational Site
  • 1160.67.32011 Boehringer Ingelheim Investigational Site
  • 1160.67.32005 Boehringer Ingelheim Investigational Site
  • 1160.67.32002 Boehringer Ingelheim Investigational Site
  • 1160.67.32006 Boehringer Ingelheim Investigational Site
  • 1160.67.32003 Boehringer Ingelheim Investigational Site
  • 1160.67.32001 Boehringer Ingelheim Investigational Site
  • 1160.67.32004 Boehringer Ingelheim Investigational Site
  • 1160.67.59007 Boehringer Ingelheim Investigational Site
  • 1160.67.59009 Boehringer Ingelheim Investigational Site
  • 1160.67.59003 Boehringer Ingelheim Investigational Site
  • 1160.67.59012 Boehringer Ingelheim Investigational Site
  • 1160.67.59006 Boehringer Ingelheim Investigational Site
  • 1160.67.59001 Boehringer Ingelheim Investigational Site
  • 1160.67.59002 Boehringer Ingelheim Investigational Site
  • 1160.67.59004 Boehringer Ingelheim Investigational Site
  • 1160.67.59005 Boehringer Ingelheim Investigational Site
  • 1160.67.59008 Boehringer Ingelheim Investigational Site
  • 1160.67.59010 Boehringer Ingelheim Investigational Site
  • 1160.67.11009 Boehringer Ingelheim Investigational Site
  • 1160.67.11003 Boehringer Ingelheim Investigational Site
  • 1160.67.11012 Boehringer Ingelheim Investigational Site
  • 1160.67.11008 Boehringer Ingelheim Investigational Site
  • 1160.67.11018 Boehringer Ingelheim Investigational Site
  • 1160.67.11017 Boehringer Ingelheim Investigational Site
  • 1160.67.11010 Boehringer Ingelheim Investigational Site
  • 1160.67.11020 Boehringer Ingelheim Investigational Site
  • 1160.67.11004 Boehringer Ingelheim Investigational Site
  • 1160.67.11016 Boehringer Ingelheim Investigational Site
  • 1160.67.11006 Boehringer Ingelheim Investigational Site
  • 1160.67.11014 Boehringer Ingelheim Investigational Site
  • 1160.67.42007 Boehringer Ingelheim Investigational Site
  • 1160.67.42005 Boehringer Ingelheim Investigational Site
  • 1160.67.42008 Boehringer Ingelheim Investigational Site
  • 1160.67.42001 Boehringer Ingelheim Investigational Site
  • 1160.67.42003 Boehringer Ingelheim Investigational Site
  • 1160.67.42002 Boehringer Ingelheim Investigational Site
  • 1160.67.45001 Boehringer Ingelheim Investigational Site
  • 1160.67.45003 Boehringer Ingelheim Investigational Site
  • 1160.67.45002 Boehringer Ingelheim Investigational Site
  • 1160.67.45004 Boehringer Ingelheim Investigational Site
  • 1160.67.58001 Boehringer Ingelheim Investigational Site
  • 1160.67.58004 Boehringer Ingelheim Investigational Site
  • 1160.67.58003 Boehringer Ingelheim Investigational Site
  • 1160.67.58002 Boehringer Ingelheim Investigational Site
  • 1160.67.3305A Boehringer Ingelheim Investigational Site
  • 1160.67.3305B Boehringer Ingelheim Investigational Site
  • 1160.67.3303A Boehringer Ingelheim Investigational Site
  • 1160.67.3303B Boehringer Ingelheim Investigational Site
  • 1160.67.3303C Boehringer Ingelheim Investigational Site
  • 1160.67.3303D Boehringer Ingelheim Investigational Site
  • 1160.67.3301A Boehringer Ingelheim Investigational Site
  • 1160.67.95001 Boehringer Ingelheim Investigational Site
  • 1160.67.95002 Boehringer Ingelheim Investigational Site
  • 1160.67.95003 Boehringer Ingelheim Investigational Site
  • 1160.67.95004 Boehringer Ingelheim Investigational Site
  • 1160.67.95005 Boehringer Ingelheim Investigational Site
  • 1160.67.95006 Boehringer Ingelheim Investigational Site
  • 1160.67.49001 Boehringer Ingelheim Investigational Site
  • 1160.67.49007 Boehringer Ingelheim Investigational Site
  • 1160.67.49017 Boehringer Ingelheim Investigational Site
  • 1160.67.49006 Boehringer Ingelheim Investigational Site
  • 1160.67.49019 Boehringer Ingelheim Investigational Site
  • 1160.67.49008 Boehringer Ingelheim Investigational Site
  • 1160.67.49015 Boehringer Ingelheim Investigational Site
  • 1160.67.49004 Boehringer Ingelheim Investigational Site
  • 1160.67.36001 Boehringer Ingelheim Investigational Site
  • 1160.67.36003 Boehringer Ingelheim Investigational Site
  • 1160.67.36004 Boehringer Ingelheim Investigational Site
  • 1160.67.36002 Boehringer Ingelheim Investigational Site
  • 1160.67.36007 Boehringer Ingelheim Investigational Site
  • 1160.67.36006 Boehringer Ingelheim Investigational Site
  • 1160.67.36008 Boehringer Ingelheim Investigational Site
  • 1160.67.36009 Boehringer Ingelheim Investigational Site
  • 1160.67.36005 Boehringer Ingelheim Investigational Site
  • 1160.67.91004 Boehringer Ingelheim Investigational Site
  • 1160.67.91001 Boehringer Ingelheim Investigational Site
  • 1160.67.91005 Boehringer Ingelheim Investigational Site
  • 1160.67.91007 Boehringer Ingelheim Investigational Site
  • 1160.67.91002 Boehringer Ingelheim Investigational Site
  • 1160.67.91003 Boehringer Ingelheim Investigational Site
  • 1160.67.91006 Boehringer Ingelheim Investigational Site
  • 1160.67.53001 Boehringer Ingelheim Investigational Site
  • 1160.67.53002 Boehringer Ingelheim Investigational Site
  • 1160.67.39006 Boehringer Ingelheim Investigational Site
  • 1160.67.39003 Boehringer Ingelheim Investigational Site
  • 1160.67.39005 Boehringer Ingelheim Investigational Site
  • 1160.67.39001 Boehringer Ingelheim Investigational Site
  • 1160.67.39002 Boehringer Ingelheim Investigational Site
  • 1160.67.39004 Boehringer Ingelheim Investigational Site
  • 1160.67.82010 Boehringer Ingelheim Investigational Site
  • 1160.67.82008 Boehringer Ingelheim Investigational Site
  • 1160.67.82009 Boehringer Ingelheim Investigational Site
  • 1160.67.82013 Boehringer Ingelheim Investigational Site
  • 1160.67.82006 Boehringer Ingelheim Investigational Site
  • 1160.67.82007 Boehringer Ingelheim Investigational Site
  • 1160.67.82012 Boehringer Ingelheim Investigational Site
  • 1160.67.82005 Boehringer Ingelheim Investigational Site
  • 1160.67.82011 Boehringer Ingelheim Investigational Site
  • 1160.67.82001 Boehringer Ingelheim Investigational Site
  • 1160.67.82002 Boehringer Ingelheim Investigational Site
  • 1160.67.82003 Boehringer Ingelheim Investigational Site
  • 1160.67.82004 Boehringer Ingelheim Investigational Site
  • 1160.67.31001 Boehringer Ingelheim Investigational Site
  • 1160.67.31003 Boehringer Ingelheim Investigational Site
  • 1160.67.31007 Boehringer Ingelheim Investigational Site
  • 1160.67.31009 Boehringer Ingelheim Investigational Site
  • 1160.67.31002 Boehringer Ingelheim Investigational Site
  • 1160.67.31006 Boehringer Ingelheim Investigational Site
  • 1160.67.31011 Boehringer Ingelheim Investigational Site
  • 1160.67.31005 Boehringer Ingelheim Investigational Site
  • 1160.67.31008 Boehringer Ingelheim Investigational Site
  • 1160.67.31004 Boehringer Ingelheim Investigational Site
  • 1160.67.47005 Boehringer Ingelheim Investigational Site
  • 1160.67.47002 Boehringer Ingelheim Investigational Site
  • 1160.67.47003 Boehringer Ingelheim Investigational Site
  • 1160.67.47004 Boehringer Ingelheim Investigational Site
  • 1160.67.47001 Boehringer Ingelheim Investigational Site
  • 1160.67.48003 Boehringer Ingelheim Investigational Site
  • 1160.67.48006 Boehringer Ingelheim Investigational Site
  • 1160.67.48004 Boehringer Ingelheim Investigational Site
  • 1160.67.48005 Boehringer Ingelheim Investigational Site
  • 1160.67.48002 Boehringer Ingelheim Investigational Site
  • 1160.67.48001 Boehringer Ingelheim Investigational Site
  • 1160.67.40006 Boehringer Ingelheim Investigational Site
  • 1160.67.40005 Boehringer Ingelheim Investigational Site
  • 1160.67.40001 Boehringer Ingelheim Investigational Site
  • 1160.67.40003 Boehringer Ingelheim Investigational Site
  • 1160.67.40004 Boehringer Ingelheim Investigational Site
  • 1160.67.40002 Boehringer Ingelheim Investigational Site
  • 1160.67.40007 Boehringer Ingelheim Investigational Site
  • 1160.67.70001 Boehringer Ingelheim Investigational Site
  • 1160.67.70002 Boehringer Ingelheim Investigational Site
  • 1160.67.70003 Boehringer Ingelheim Investigational Site
  • 1160.67.70004 Boehringer Ingelheim Investigational Site
  • 1160.67.70005 Boehringer Ingelheim Investigational Site
  • 1160.67.70006 Boehringer Ingelheim Investigational Site
  • 1160.67.70007 Boehringer Ingelheim Investigational Site
  • 1160.67.70010 Boehringer Ingelheim Investigational Site
  • 1160.67.70011 Boehringer Ingelheim Investigational Site
  • 1160.67.70008 Boehringer Ingelheim Investigational Site
  • 1160.67.70009 Boehringer Ingelheim Investigational Site
  • 1160.67.34001 Boehringer Ingelheim Investigational Site
  • 1160.67.34002 Boehringer Ingelheim Investigational Site
  • 1160.67.34005 Boehringer Ingelheim Investigational Site
  • 1160.67.34006 Boehringer Ingelheim Investigational Site
  • 1160.67.34003 Boehringer Ingelheim Investigational Site
  • 1160.67.34004 Boehringer Ingelheim Investigational Site
  • 1160.67.46004 Boehringer Ingelheim Investigational Site
  • 1160.67.46006 Boehringer Ingelheim Investigational Site
  • 1160.67.46007 Boehringer Ingelheim Investigational Site
  • 1160.67.46005 Boehringer Ingelheim Investigational Site
  • 1160.67.46002 Boehringer Ingelheim Investigational Site
  • 1160.67.46001 Boehringer Ingelheim Investigational Site
  • 1160.67.46003 Boehringer Ingelheim Investigational Site
  • 1160.67.38002 Boehringer Ingelheim Investigational Site
  • 1160.67.38004 Boehringer Ingelheim Investigational Site
  • 1160.67.38007 Boehringer Ingelheim Investigational Site
  • 1160.67.38001 Boehringer Ingelheim Investigational Site
  • 1160.67.38003 Boehringer Ingelheim Investigational Site
  • 1160.67.38005 Boehringer Ingelheim Investigational Site
  • 1160.67.38008 Boehringer Ingelheim Investigational Site
  • 1160.67.38006 Boehringer Ingelheim Investigational Site
  • 1160.67.44003 Boehringer Ingelheim Investigational Site
  • 1160.67.44002 Boehringer Ingelheim Investigational Site
  • 1160.67.44001 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Dabigatran etexilate 50mg

Dabigatran etexilate 75mg

Dabigatran etexilate 110mg

dabigatran etexilate 150mg

placebo

Arm Description

twice daily dosing,

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

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

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

matched placebo

Outcomes

Primary Outcome Measures

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).

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
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
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.
Number of Participants With Any Reduction of D-dimer Concentration
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.
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).
Laboratory Analyses
Number of patients with possible clinically significant abnormalities. Clinically significant abnormalities refers to the increase or decrease from baseline.

Full Information

First Posted
February 13, 2008
Last Updated
February 10, 2014
Sponsor
Boehringer Ingelheim
Collaborators
Uppsala University
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1. Study Identification

Unique Protocol Identification Number
NCT00621855
Brief Title
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

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim
Collaborators
Uppsala University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1878 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dabigatran etexilate 50mg
Arm Type
Experimental
Arm Description
twice daily dosing,
Arm Title
Dabigatran etexilate 75mg
Arm Type
Experimental
Arm Description
twice daily dosing, patients with moderate renal impairment allocated 50mg bid
Arm Title
Dabigatran etexilate 110mg
Arm Type
Experimental
Arm Description
twice daily dosing, patients with moderate renal impairment allocated 75mg bid
Arm Title
dabigatran etexilate 150mg
Arm Type
Experimental
Arm Description
twice daily dosing, patients with moderate renal impairment allocated 110mg bid
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
matched placebo
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
matched placebo
Intervention Type
Drug
Intervention Name(s)
dabigatran etexilate
Intervention Description
capsules, twice daily, 26 weeks treatment
Intervention Type
Drug
Intervention Name(s)
dabigatran etexilate
Intervention Description
capsules, twice daily, 26 weeks treatment
Intervention Type
Drug
Intervention Name(s)
dabigatran etexilate
Intervention Description
capsules, twice daily, 26 weeks treatment
Intervention Type
Drug
Intervention Name(s)
dabigatran etexilate
Intervention Description
capsules, twice daily, 26 weeks treatment
Primary Outcome Measure Information:
Title
Number of Participants Displaying the Composite of Major and Clinically Relevant Minor Bleeding Events During Total Observation Time
Description
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).
Time Frame
6 month treatment period + 2 week post treatment follow up
Secondary Outcome Measure Information:
Title
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
Description
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
Time Frame
6 month treatment period + 2 week post treatment follow up
Title
Individual Occurrence of Death (Cardiovascular and All-cause), Non-fatal MI, Severe Recurrent Ischaemia and Non-haemorrhagic Stroke During Six Months of Treatment
Description
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.
Time Frame
6 month treatment period + 2 week post treatment follow up
Title
Number of Participants With Any Reduction of D-dimer Concentration
Time Frame
at 1 week and 4 weeks
Title
Change From Baseline in log10 D-dimer After 1 and 4 Weeks
Description
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.
Time Frame
Baseline and at 1 week and 4 weeks
Title
Number of Participants With Bleeding Events During Total Observation Time
Description
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).
Time Frame
6 month treatment period + 2 week post treatment follow up
Title
Laboratory Analyses
Description
Number of patients with possible clinically significant abnormalities. Clinically significant abnormalities refers to the increase or decrease from baseline.
Time Frame
6 month treatment period + 2 week post treatment follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1160.67.10002 Boehringer Ingelheim Investigational Site
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
1160.67.32008 Boehringer Ingelheim Investigational Site
City
Bouge/Namur
Country
Belgium
Facility Name
1160.67.32011 Boehringer Ingelheim Investigational Site
City
Brasschaat
Country
Belgium
Facility Name
1160.67.32005 Boehringer Ingelheim Investigational Site
City
Edegem
Country
Belgium
Facility Name
1160.67.32002 Boehringer Ingelheim Investigational Site
City
Genk
Country
Belgium
Facility Name
1160.67.32006 Boehringer Ingelheim Investigational Site
City
Gilly
Country
Belgium
Facility Name
1160.67.32003 Boehringer Ingelheim Investigational Site
City
Hasselt
Country
Belgium
Facility Name
1160.67.32001 Boehringer Ingelheim Investigational Site
City
Leuven
Country
Belgium
Facility Name
1160.67.32004 Boehringer Ingelheim Investigational Site
City
Tienen
Country
Belgium
Facility Name
1160.67.59007 Boehringer Ingelheim Investigational Site
City
Bourgas
Country
Bulgaria
Facility Name
1160.67.59009 Boehringer Ingelheim Investigational Site
City
Dimitrovgrad
Country
Bulgaria
Facility Name
1160.67.59003 Boehringer Ingelheim Investigational Site
City
Pleven
Country
Bulgaria
Facility Name
1160.67.59012 Boehringer Ingelheim Investigational Site
City
Pleven
Country
Bulgaria
Facility Name
1160.67.59006 Boehringer Ingelheim Investigational Site
City
Rousse
Country
Bulgaria
Facility Name
1160.67.59001 Boehringer Ingelheim Investigational Site
City
Sofia
Country
Bulgaria
Facility Name
1160.67.59002 Boehringer Ingelheim Investigational Site
City
Sofia
Country
Bulgaria
Facility Name
1160.67.59004 Boehringer Ingelheim Investigational Site
City
Sofia
Country
Bulgaria
Facility Name
1160.67.59005 Boehringer Ingelheim Investigational Site
City
Sofia
Country
Bulgaria
Facility Name
1160.67.59008 Boehringer Ingelheim Investigational Site
City
Sofia
Country
Bulgaria
Facility Name
1160.67.59010 Boehringer Ingelheim Investigational Site
City
Sofia
Country
Bulgaria
Facility Name
1160.67.11009 Boehringer Ingelheim Investigational Site
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
1160.67.11003 Boehringer Ingelheim Investigational Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
1160.67.11012 Boehringer Ingelheim Investigational Site
City
Cambridge
State/Province
Ontario
Country
Canada
Facility Name
1160.67.11008 Boehringer Ingelheim Investigational Site
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
1160.67.11018 Boehringer Ingelheim Investigational Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
1160.67.11017 Boehringer Ingelheim Investigational Site
City
Mississauga
State/Province
Ontario
Country
Canada
Facility Name
1160.67.11010 Boehringer Ingelheim Investigational Site
City
Sudbury
State/Province
Ontario
Country
Canada
Facility Name
1160.67.11020 Boehringer Ingelheim Investigational Site
City
Sudbury
State/Province
Ontario
Country
Canada
Facility Name
1160.67.11004 Boehringer Ingelheim Investigational Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
1160.67.11016 Boehringer Ingelheim Investigational Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
1160.67.11006 Boehringer Ingelheim Investigational Site
City
Terrebonne
State/Province
Quebec
Country
Canada
Facility Name
1160.67.11014 Boehringer Ingelheim Investigational Site
City
Quebec
Country
Canada
Facility Name
1160.67.42007 Boehringer Ingelheim Investigational Site
City
Hradec Kralove
Country
Czech Republic
Facility Name
1160.67.42005 Boehringer Ingelheim Investigational Site
City
Litomerice
Country
Czech Republic
Facility Name
1160.67.42008 Boehringer Ingelheim Investigational Site
City
Ostrava
Country
Czech Republic
Facility Name
1160.67.42001 Boehringer Ingelheim Investigational Site
City
Prague
Country
Czech Republic
Facility Name
1160.67.42003 Boehringer Ingelheim Investigational Site
City
Teplice
Country
Czech Republic
Facility Name
1160.67.42002 Boehringer Ingelheim Investigational Site
City
Zlin
Country
Czech Republic
Facility Name
1160.67.45001 Boehringer Ingelheim Investigational Site
City
Aarhus C
Country
Denmark
Facility Name
1160.67.45003 Boehringer Ingelheim Investigational Site
City
Hvidovre
Country
Denmark
Facility Name
1160.67.45002 Boehringer Ingelheim Investigational Site
City
Odense
Country
Denmark
Facility Name
1160.67.45004 Boehringer Ingelheim Investigational Site
City
Roskilde
Country
Denmark
Facility Name
1160.67.58001 Boehringer Ingelheim Investigational Site
City
HUS
Country
Finland
Facility Name
1160.67.58004 Boehringer Ingelheim Investigational Site
City
Jyväskylä
Country
Finland
Facility Name
1160.67.58003 Boehringer Ingelheim Investigational Site
City
Kuopio
Country
Finland
Facility Name
1160.67.58002 Boehringer Ingelheim Investigational Site
City
Pori
Country
Finland
Facility Name
1160.67.3305A Boehringer Ingelheim Investigational Site
City
Brest Cedex
Country
France
Facility Name
1160.67.3305B Boehringer Ingelheim Investigational Site
City
Brest Cedex
Country
France
Facility Name
1160.67.3303A Boehringer Ingelheim Investigational Site
City
Dijon Cedex
Country
France
Facility Name
1160.67.3303B Boehringer Ingelheim Investigational Site
City
Dijon Cedex
Country
France
Facility Name
1160.67.3303C Boehringer Ingelheim Investigational Site
City
Dijon Cedex
Country
France
Facility Name
1160.67.3303D Boehringer Ingelheim Investigational Site
City
Dijon Cedex
Country
France
Facility Name
1160.67.3301A Boehringer Ingelheim Investigational Site
City
Paris
Country
France
Facility Name
1160.67.95001 Boehringer Ingelheim Investigational Site
City
Tbilisi
Country
Georgia
Facility Name
1160.67.95002 Boehringer Ingelheim Investigational Site
City
Tbilisi
Country
Georgia
Facility Name
1160.67.95003 Boehringer Ingelheim Investigational Site
City
Tbilisi
Country
Georgia
Facility Name
1160.67.95004 Boehringer Ingelheim Investigational Site
City
Tbilisi
Country
Georgia
Facility Name
1160.67.95005 Boehringer Ingelheim Investigational Site
City
Tbilisi
Country
Georgia
Facility Name
1160.67.95006 Boehringer Ingelheim Investigational Site
City
Tbilisi
Country
Georgia
Facility Name
1160.67.49001 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1160.67.49007 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1160.67.49017 Boehringer Ingelheim Investigational Site
City
Dresden
Country
Germany
Facility Name
1160.67.49006 Boehringer Ingelheim Investigational Site
City
Hannover
Country
Germany
Facility Name
1160.67.49019 Boehringer Ingelheim Investigational Site
City
Homburg/Saar
Country
Germany
Facility Name
1160.67.49008 Boehringer Ingelheim Investigational Site
City
Ludwigshafen am Rhein
Country
Germany
Facility Name
1160.67.49015 Boehringer Ingelheim Investigational Site
City
Neuss
Country
Germany
Facility Name
1160.67.49004 Boehringer Ingelheim Investigational Site
City
Rostock
Country
Germany
Facility Name
1160.67.36001 Boehringer Ingelheim Investigational Site
City
Budapest
Country
Hungary
Facility Name
1160.67.36003 Boehringer Ingelheim Investigational Site
City
Budapest
Country
Hungary
Facility Name
1160.67.36004 Boehringer Ingelheim Investigational Site
City
Budapest
Country
Hungary
Facility Name
1160.67.36002 Boehringer Ingelheim Investigational Site
City
Debrecen
Country
Hungary
Facility Name
1160.67.36007 Boehringer Ingelheim Investigational Site
City
Kecskemet
Country
Hungary
Facility Name
1160.67.36006 Boehringer Ingelheim Investigational Site
City
Komarom
Country
Hungary
Facility Name
1160.67.36008 Boehringer Ingelheim Investigational Site
City
Miskolc
Country
Hungary
Facility Name
1160.67.36009 Boehringer Ingelheim Investigational Site
City
Mosonmagyarovar
Country
Hungary
Facility Name
1160.67.36005 Boehringer Ingelheim Investigational Site
City
Zalaegerszeg
Country
Hungary
Facility Name
1160.67.91004 Boehringer Ingelheim Investigational Site
City
Amedabad
Country
India
Facility Name
1160.67.91001 Boehringer Ingelheim Investigational Site
City
Chennai
Country
India
Facility Name
1160.67.91005 Boehringer Ingelheim Investigational Site
City
Hyderabad
Country
India
Facility Name
1160.67.91007 Boehringer Ingelheim Investigational Site
City
Lucknow
Country
India
Facility Name
1160.67.91002 Boehringer Ingelheim Investigational Site
City
Mumbai
Country
India
Facility Name
1160.67.91003 Boehringer Ingelheim Investigational Site
City
Pune
Country
India
Facility Name
1160.67.91006 Boehringer Ingelheim Investigational Site
City
Pune
Country
India
Facility Name
1160.67.53001 Boehringer Ingelheim Investigational Site
City
Dublin
Country
Ireland
Facility Name
1160.67.53002 Boehringer Ingelheim Investigational Site
City
Dublin
Country
Ireland
Facility Name
1160.67.39006 Boehringer Ingelheim Investigational Site
City
Ascoli Piceno
Country
Italy
Facility Name
1160.67.39003 Boehringer Ingelheim Investigational Site
City
Milano
Country
Italy
Facility Name
1160.67.39005 Boehringer Ingelheim Investigational Site
City
Milano
Country
Italy
Facility Name
1160.67.39001 Boehringer Ingelheim Investigational Site
City
Parma
Country
Italy
Facility Name
1160.67.39002 Boehringer Ingelheim Investigational Site
City
S. Maria Capua Vetere (CE)
Country
Italy
Facility Name
1160.67.39004 Boehringer Ingelheim Investigational Site
City
Torino
Country
Italy
Facility Name
1160.67.82010 Boehringer Ingelheim Investigational Site
City
Busan
Country
Korea, Republic of
Facility Name
1160.67.82008 Boehringer Ingelheim Investigational Site
City
Daegu
Country
Korea, Republic of
Facility Name
1160.67.82009 Boehringer Ingelheim Investigational Site
City
Daegu
Country
Korea, Republic of
Facility Name
1160.67.82013 Boehringer Ingelheim Investigational Site
City
Daejeon
Country
Korea, Republic of
Facility Name
1160.67.82006 Boehringer Ingelheim Investigational Site
City
Daejoen
Country
Korea, Republic of
Facility Name
1160.67.82007 Boehringer Ingelheim Investigational Site
City
Incheon
Country
Korea, Republic of
Facility Name
1160.67.82012 Boehringer Ingelheim Investigational Site
City
Jeonju
Country
Korea, Republic of
Facility Name
1160.67.82005 Boehringer Ingelheim Investigational Site
City
Kwang-Ju
Country
Korea, Republic of
Facility Name
1160.67.82011 Boehringer Ingelheim Investigational Site
City
Pusan
Country
Korea, Republic of
Facility Name
1160.67.82001 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1160.67.82002 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1160.67.82003 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1160.67.82004 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1160.67.31001 Boehringer Ingelheim Investigational Site
City
Amsterdam
Country
Netherlands
Facility Name
1160.67.31003 Boehringer Ingelheim Investigational Site
City
Den Bosch
Country
Netherlands
Facility Name
1160.67.31007 Boehringer Ingelheim Investigational Site
City
Den Haag
Country
Netherlands
Facility Name
1160.67.31009 Boehringer Ingelheim Investigational Site
City
Ede
Country
Netherlands
Facility Name
1160.67.31002 Boehringer Ingelheim Investigational Site
City
Groningen
Country
Netherlands
Facility Name
1160.67.31006 Boehringer Ingelheim Investigational Site
City
Helmond
Country
Netherlands
Facility Name
1160.67.31011 Boehringer Ingelheim Investigational Site
City
Hoogeveen
Country
Netherlands
Facility Name
1160.67.31005 Boehringer Ingelheim Investigational Site
City
Rotterdam
Country
Netherlands
Facility Name
1160.67.31008 Boehringer Ingelheim Investigational Site
City
Spijkenisse
Country
Netherlands
Facility Name
1160.67.31004 Boehringer Ingelheim Investigational Site
City
Tilburg
Country
Netherlands
Facility Name
1160.67.47005 Boehringer Ingelheim Investigational Site
City
Drammen
Country
Norway
Facility Name
1160.67.47002 Boehringer Ingelheim Investigational Site
City
Hamar
Country
Norway
Facility Name
1160.67.47003 Boehringer Ingelheim Investigational Site
City
Haugesund
Country
Norway
Facility Name
1160.67.47004 Boehringer Ingelheim Investigational Site
City
Hønefoss
Country
Norway
Facility Name
1160.67.47001 Boehringer Ingelheim Investigational Site
City
Oslo
Country
Norway
Facility Name
1160.67.48003 Boehringer Ingelheim Investigational Site
City
Bydgoszcz
Country
Poland
Facility Name
1160.67.48006 Boehringer Ingelheim Investigational Site
City
Bydgoszcz
Country
Poland
Facility Name
1160.67.48004 Boehringer Ingelheim Investigational Site
City
Gdynia
Country
Poland
Facility Name
1160.67.48005 Boehringer Ingelheim Investigational Site
City
Inowroclaw
Country
Poland
Facility Name
1160.67.48002 Boehringer Ingelheim Investigational Site
City
Sopot
Country
Poland
Facility Name
1160.67.48001 Boehringer Ingelheim Investigational Site
City
Warsaw
Country
Poland
Facility Name
1160.67.40006 Boehringer Ingelheim Investigational Site
City
Baia Mare
Country
Romania
Facility Name
1160.67.40005 Boehringer Ingelheim Investigational Site
City
Braila
Country
Romania
Facility Name
1160.67.40001 Boehringer Ingelheim Investigational Site
City
Bucharest
Country
Romania
Facility Name
1160.67.40003 Boehringer Ingelheim Investigational Site
City
Bucharest
Country
Romania
Facility Name
1160.67.40004 Boehringer Ingelheim Investigational Site
City
Bucharest
Country
Romania
Facility Name
1160.67.40002 Boehringer Ingelheim Investigational Site
City
Oradea
Country
Romania
Facility Name
1160.67.40007 Boehringer Ingelheim Investigational Site
City
Tg. Mures
Country
Romania
Facility Name
1160.67.70001 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
1160.67.70002 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
1160.67.70003 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
1160.67.70004 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
1160.67.70005 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
1160.67.70006 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
1160.67.70007 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
1160.67.70010 Boehringer Ingelheim Investigational Site
City
Saratov
Country
Russian Federation
Facility Name
1160.67.70011 Boehringer Ingelheim Investigational Site
City
Saratov
Country
Russian Federation
Facility Name
1160.67.70008 Boehringer Ingelheim Investigational Site
City
St. Petersburg
Country
Russian Federation
Facility Name
1160.67.70009 Boehringer Ingelheim Investigational Site
City
St. Petersburg
Country
Russian Federation
Facility Name
1160.67.34001 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1160.67.34002 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1160.67.34005 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1160.67.34006 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1160.67.34003 Boehringer Ingelheim Investigational Site
City
Sabadell (Barcelona)
Country
Spain
Facility Name
1160.67.34004 Boehringer Ingelheim Investigational Site
City
Tarragona
Country
Spain
Facility Name
1160.67.46004 Boehringer Ingelheim Investigational Site
City
Göteborg
Country
Sweden
Facility Name
1160.67.46006 Boehringer Ingelheim Investigational Site
City
Göteborg
Country
Sweden
Facility Name
1160.67.46007 Boehringer Ingelheim Investigational Site
City
Malmö
Country
Sweden
Facility Name
1160.67.46005 Boehringer Ingelheim Investigational Site
City
Motala
Country
Sweden
Facility Name
1160.67.46002 Boehringer Ingelheim Investigational Site
City
Stockholm
Country
Sweden
Facility Name
1160.67.46001 Boehringer Ingelheim Investigational Site
City
Uppsala
Country
Sweden
Facility Name
1160.67.46003 Boehringer Ingelheim Investigational Site
City
Vaesteraas
Country
Sweden
Facility Name
1160.67.38002 Boehringer Ingelheim Investigational Site
City
Ivano-Frankovsk
Country
Ukraine
Facility Name
1160.67.38004 Boehringer Ingelheim Investigational Site
City
Kharkov
Country
Ukraine
Facility Name
1160.67.38007 Boehringer Ingelheim Investigational Site
City
Kharkov
Country
Ukraine
Facility Name
1160.67.38001 Boehringer Ingelheim Investigational Site
City
Kiev
Country
Ukraine
Facility Name
1160.67.38003 Boehringer Ingelheim Investigational Site
City
Kiev
Country
Ukraine
Facility Name
1160.67.38005 Boehringer Ingelheim Investigational Site
City
Kiev
Country
Ukraine
Facility Name
1160.67.38008 Boehringer Ingelheim Investigational Site
City
Nikolayev
Country
Ukraine
Facility Name
1160.67.38006 Boehringer Ingelheim Investigational Site
City
Odessa
Country
Ukraine
Facility Name
1160.67.44003 Boehringer Ingelheim Investigational Site
City
Brighton
Country
United Kingdom
Facility Name
1160.67.44002 Boehringer Ingelheim Investigational Site
City
Exeter
Country
United Kingdom
Facility Name
1160.67.44001 Boehringer Ingelheim Investigational Site
City
Middlesbrough
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1160/1160.67_U10-1294.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1160/1160.67_literature.pdf
Description
Related Info

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