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

NCT00818753 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2014-06-09

Study results available
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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).

Conditions

  • Heart Catheterization

Interventions

DRUG

dabigatran 110 mg

comparison of different dabigatran dosages with unfractionated heparin

DRUG

dabigatran 150 mg

comparison of different dabigatran dosages with unfractionated heparin

DRUG

unfractionated heparin

comparison of different dosages dabigatran with unfractionated heparin

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-08-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

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 NCT00818753 on ClinicalTrials.gov