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

June 3, 2014 updated by: Boehringer Ingelheim

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Alkmaar, Netherlands
        • 1160.73.31004 Boehringer Ingelheim Investigational Site
      • Nieuwegein, Netherlands
        • 1160.73.31003 Boehringer Ingelheim Investigational Site
      • Rotterdam, Netherlands
        • 1160.73.1 Boehringer Ingelheim Investigational Site
      • Rotterdam, Netherlands
        • 1160.73.31002 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dabigatran 110 mg
experimental drug therapy in this indication
Drug: dabigatran 110 mg
comparison of different dabigatran dosages with unfractionated heparin
Experimental: Dabigatran 150 mg
experimental drug therapy in this indication
Drug: dabigatran 150 mg
comparison of different dabigatran dosages with unfractionated heparin
Active Comparator: Unfractionated Heparin
standard therapy in this indication as comparator
Drug: unfractionated heparin
comparison of different dosages dabigatran with unfractionated heparin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Require Anticoagulation and/or Have Clinical Signs of Catheter Related Thrombosis
Time Frame: From 22 to 165 minutes
Investigator reported outcome
From 22 to 165 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

January 7, 2009

First Submitted That Met QC Criteria

January 7, 2009

First Posted (Estimate)

January 8, 2009

Study Record Updates

Last Update Posted (Estimate)

June 9, 2014

Last Update Submitted That Met QC Criteria

June 3, 2014

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1160.73
  • 2007-007536-25 (EudraCT Number: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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