Phase 2 N=53 Randomized Treatment

Randomized, Open Label Study of Dabigatran Etexilate in Elective Percutaneous Coronary Intervention

Heart Catheterization

Bottom Line

View on ClinicalTrials.gov: NCT00818753 ↗

Enrolled (actual)

Serious AEs

2.0%

Results posted

Oct 2011

Primary outcome: Primary: Percentage of Participants Who Require Anticoagulation and/or Have Clinical Signs of Catheter Related Thrombosis — 10.5; 14.3; 10.0 Percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: dabigatran 110 mg (Drug); dabigatran 150 mg (Drug); unfractionated heparin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Boehringer Ingelheim
Primary completion: Aug 2010

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	—

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).

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

View full record on ClinicalTrials.gov →

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.