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OpenTrials
Completed

NCT Number: NCT00818753

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

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).

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Key information

Conditions

Heart Catheterization

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

1160.73.31004 Boehringer Ingelheim Investigational Site, Alkmaar, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dabigatran 110 mg

Drug

comparison of different dabigatran dosages with unfractionated heparin

dabigatran 150 mg

Drug

comparison of different dabigatran dosages with unfractionated heparin

Unfractionated heparin

Drug

comparison of different dosages dabigatran with unfractionated heparin

Primary outcomes

  1. 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

Secondary outcomes

  1. Percentage of Participants Who Experienced Catheter Related Thrombi Requiring Rescue Anticoagulation Therapy

    Time frame: From 22 to 165 minutes

    Investigator reported outcome

  2. 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

  3. 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

  4. 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).

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
First posted
Jan 8, 2009
Registry last updated
Jun 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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