Heart Catheterization Clinical Trial
Official title:
The Safety and Pharmacodynamics of Two Doses of Dabigatran Etexilate in Patients Undergoing Cardiac Catheterization
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).
Status | Completed |
Enrollment | 53 |
Est. completion date | |
Est. primary completion date | August 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | 1160.73.31004 Boehringer Ingelheim Investigational Site | Alkmaar | |
Netherlands | 1160.73.31003 Boehringer Ingelheim Investigational Site | Nieuwegein | |
Netherlands | 1160.73.1 Boehringer Ingelheim Investigational Site | Rotterdam | |
Netherlands | 1160.73.31002 Boehringer Ingelheim Investigational Site | Rotterdam |
Lead Sponsor | Collaborator |
---|---|
Boehringer Ingelheim |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants Who Require Anticoagulation and/or Have Clinical Signs of Catheter Related Thrombosis | Investigator reported outcome | From 22 to 165 minutes | No |
Secondary | Percentage of Participants Who Experienced Catheter Related Thrombi Requiring Rescue Anticoagulation Therapy | Investigator reported outcome | From 22 to 165 minutes | No |
Secondary | Percentage of Participants Who Experienced Abrupt Vessel Closure, New Thrombus With Reduced Reflow or no Reflow | Investigator reported outcome | From 22 to 165 minutes | No |
Secondary | Percentage of Participants Who Experienced Catheter Related Thrombi Not Resulting in Clinical Complications Including Guide-catheter (Wire) Thrombosis | Investigator reported outcome | From 22 to 165 minutes | No |
Secondary | Number of Participants With Bleeding Events | Bleeding is categorized using the TIMI criteria as major or minor bleeding. The time window for inclusion of bleeding events was up until 3 days post-procedure or discharge (whichever occurred first). | First administration until 7-14 days after PCI (Percutaneous Coronary Intervention) | Yes |
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