Phase 2
Completed N=53
Randomized, Open Label Study of Dabigatran Etexilate in Elective Percutaneous Coronary Intervention
Heart Catheterization
Source: ClinicalTrials.gov NCT00818753 ↗
Enrolled (actual)
53
Serious AEs
2.0%
Results posted
Oct 2011
Primary outcomePrimary: Percentage of Participants Who Require Anticoagulation and/or Have Clinical Signs of Catheter Related Thrombosis — 10.5; 14.3; 10.0 Percentage of participants
Summary
To assess whether two doses of dabigatran etexilate (110 mg twice daily (b.i.d) and 150 mg twice daily (b.i.d)) as compared to unfractionated heparin (UFH), both in addition to a standard dual antiplatelet regimen, provide sufficient anticoagulation in the setting of elective percutaneous coronary intervention (PCI).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Require Anticoagulation and/or Have Clinical Signs of Catheter Related Thrombosis |
10.5; 14.3; 10.0 | — |
| SECONDARY Percentage of Participants Who Experienced Catheter Related Thrombi Requiring Rescue Anticoagulation Therapy |
0; 0; 0 | — |
| SECONDARY Percentage of Participants Who Experienced Abrupt Vessel Closure, New Thrombus With Reduced Reflow or no Reflow |
10.5; 4.8; 0 | — |
| SECONDARY Percentage of Participants Who Experienced Catheter Related Thrombi Not Resulting in Clinical Complications Including Guide-catheter (Wire) Thrombosis |
0; 0; 0 | — |
| SECONDARY Number of Participants With Bleeding Events |
0; 0; 1 | — |
Eligibility Criteria
Inclusion criteria
- patients between 18 and 85 years
- due to undergo elective PCI
- informed consent obtained
Exclusion criteria
- PCI lesion specific conditions
- class III or IV congestive heart failure
- severe hypertension
- increased bleeding risk
- thrombolytic therapy within 24 hours preceding randomization
Data sourced from ClinicalTrials.gov (NCT00818753). 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.