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

Heart Catheterization Clinical Trial

Official title:

The Safety and Pharmacodynamics of Two Doses of Dabigatran Etexilate in Patients Undergoing Cardiac Catheterization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00818753
• Other study ID #: 1160.73
• Secondary ID: 2007-007536-25
• Status: Completed
• Phase: Phase 2
• First received: January 7, 2009
• Last updated: June 3, 2014
• Start date: January 2009

Study information

• Verified date: December 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Central Committee Research Involving Human Subjects
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Catheterization

Intervention

Drug:
• dabigatran 110 mg
comparison of different dabigatran dosages with unfractionated heparin
• dabigatran 150 mg
comparison of different dabigatran dosages with unfractionated heparin
• unfractionated heparin
comparison of different dosages dabigatran with unfractionated heparin

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Netherlands, 

Outcome

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

External Links

•   Link