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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00818753
First received: January 7, 2009
Last updated: June 3, 2014
Last verified: December 2013
  Purpose

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).


Condition Intervention Phase
Heart Catheterization
Drug: dabigatran 110 mg
Drug: dabigatran 150 mg
Drug: unfractionated heparin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Safety and Pharmacodynamics of Two Doses of Dabigatran Etexilate in Patients Undergoing Cardiac Catheterization

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Percentage of Participants Who Require Anticoagulation and/or Have Clinical Signs of Catheter Related Thrombosis [ Time Frame: From 22 to 165 minutes ] [ Designated as safety issue: No ]
    Investigator reported outcome


Secondary Outcome Measures:
  • Percentage of Participants Who Experienced Catheter Related Thrombi Requiring Rescue Anticoagulation Therapy [ Time Frame: From 22 to 165 minutes ] [ Designated as safety issue: No ]
    Investigator reported outcome

  • Percentage of Participants Who Experienced Abrupt Vessel Closure, New Thrombus With Reduced Reflow or no Reflow [ Time Frame: From 22 to 165 minutes ] [ Designated as safety issue: No ]
    Investigator reported outcome

  • 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 ] [ Designated as safety issue: No ]
    Investigator reported outcome

  • Number of Participants With Bleeding Events [ Time Frame: First administration until 7-14 days after PCI (Percutaneous Coronary Intervention) ] [ Designated as safety issue: Yes ]
    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).


Enrollment: 53
Study Start Date: January 2009
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00818753

Locations
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, Netherlands
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00818753     History of Changes
Other Study ID Numbers: 1160.73, 2007-007536-25
Study First Received: January 7, 2009
Results First Received: August 5, 2011
Last Updated: June 3, 2014
Health Authority: Netherlands: Central Committee Research Involving Human Subjects

Additional relevant MeSH terms:
Calcium heparin
Dabigatran
Heparin
Anticoagulants
Antithrombins
Cardiovascular Agents
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Serine Proteinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014