CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 1,878 enrolled
Drug / intervention
placebo +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00621855
NCT00621855Phase 2Completed
CompareCT.gov

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)

Boehringer Ingelheim·interventional·Posted Feb 22, 2008·Updated Mar 12, 2014

In Brief

A Phase 2 clinical trial evaluating placebo and dabigatran etexilate for Coronary Disease. Completed, enrolled 1,878 participants across 167 sites in 24 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Disease
CountriesBelgium, Bulgaria, Canada, Czechia, Denmark, Finland, France, Georgia, Germany, Hungary, India, Ireland, Italy, Netherlands, Norway, Poland, Romania, Russia, South Korea, Spain, Sweden, Ukraine, United Kingdom, United States
CollaboratorsUppsala University

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 22, 2008
Enrollment StartMar 1, 2008
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 18.4 years ago

Interventions

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