Phase 2
Completed N=1,878
RE-DEEM Dose Finding Study for Dabigatran Etexilate in Patients With Acute Coronary Syndrome
Coronary Disease
Source: ClinicalTrials.gov NCT00621855 ↗
Enrolled (actual)
1,878
Serious AEs
8.2%
Results posted
Feb 2011
Primary outcomePrimary: Number of Participants Displaying the Composite of Major and Clinically Relevant Minor Bleeding Events During Total Observation Time — 13; 16; 32; 27 participants — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Displaying the Composite of Major and Clinically Relevant Minor Bleeding Events During Total Observation Time |
13; 16; 32; 27; 8; 356 | <0.001 sig |
| SECONDARY 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 |
17; 18; 12; 12; 14; 25 | — |
| SECONDARY Individual Occurrence of Death (Cardiovascular and All-cause), Non-fatal MI, Severe Recurrent Ischaemia and Non-haemorrhagic Stroke During Six Months of Treatment |
8; 9; 5; 4; 9; 9 | — |
| SECONDARY Number of Participants With Any Reduction of D-dimer Concentration |
290; 293; 333; 296; 264; 48 | <0.001 sig |
| SECONDARY Change From Baseline in log10 D-dimer After 1 and 4 Weeks |
0.33; 0.31; 0.29; 0.31; 0.57; 0.58 | — |
| SECONDARY Number of Participants With Bleeding Events During Total Observation Time |
3; 1; 8; 4; 2; 10 | — |
| SECONDARY Laboratory Analyses |
8; 5; 5; 2; 4; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT00621855). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.