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

Phase 2

Completed

• Conditions: Heart Catheterization
• Interventions: Drug: dabigatran 110 mg; Drug: dabigatran 150 mg; Drug: unfractionated heparin

• Registration Number: NCT00818753
• Lead Sponsor: Boehringer Ingelheim

Brief 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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-07
• Study First Submitted QC: 2009-01-07
• Study First Posted: 2009-01-08
• Primary Completion: 2010-08
• Results First Submitted: 2011-08-05
• Results First Submitted QC: 2011-09-16
• Results First Posted: 2011-10-25
• Status Verified: 2013-12
• Last Update Submitted: 2014-06-03
• Last Update Posted: 2014-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dabigatran 110 mg	dabigatran 110 mg	experimental drug therapy in this indication
Dabigatran 150 mg	dabigatran 150 mg	experimental drug therapy in this indication
Unfractionated Heparin	unfractionated heparin	standard therapy in this indication as comparator

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Require Anticoagulation and/or Have Clinical Signs of Catheter Related Thrombosis	From 22 to 165 minutes	Investigator reported outcome

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Experienced Catheter Related Thrombi Requiring Rescue Anticoagulation Therapy	From 22 to 165 minutes	Investigator reported outcome
Percentage of Participants Who Experienced Abrupt Vessel Closure, New Thrombus With Reduced Reflow or no Reflow	From 22 to 165 minutes	Investigator reported outcome
Percentage of Participants Who Experienced Catheter Related Thrombi Not Resulting in Clinical Complications Including Guide-catheter (Wire) Thrombosis	From 22 to 165 minutes	Investigator reported outcome
Number of Participants With Bleeding Events	First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)	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).

Trial Locations

Locations (4)

1160.73.31003 Boehringer Ingelheim Investigational Site; 🇳🇱 Nieuwegein, Netherlands

1160.73.31002 Boehringer Ingelheim Investigational Site; 🇳🇱 Rotterdam, Netherlands

1160.73.31004 Boehringer Ingelheim Investigational Site; 🇳🇱 Alkmaar, Netherlands

1160.73.1 Boehringer Ingelheim Investigational Site; 🇳🇱 Rotterdam, Netherlands