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

NCT00621855 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1878

Last updated 2014-03-12

Study results available
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Summary

The purpose of this trial is to evaluate the safety and indicators of efficacy of up to 4 doses of orally administered dabigatran etexilate, administered twice daily, compared to placebo when given in addition to dual antiplatelet treatment in patients with an index event (MI) at high risk for new ischaemic cardiovascular events.

Conditions

  • Coronary Disease

Interventions

DRUG

placebo

matched placebo

DRUG

dabigatran etexilate

capsules, twice daily, 26 weeks treatment

DRUG

dabigatran etexilate

capsules, twice daily, 26 weeks treatment

DRUG

dabigatran etexilate

capsules, twice daily, 26 weeks treatment

DRUG

dabigatran etexilate

capsules, twice daily, 26 weeks treatment

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-10-31

Countries

  • 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

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00621855 on ClinicalTrials.gov