Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

January 7, 2009
June 3, 2014
January 2009
August 2010   (final data collection date for primary outcome measure)
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
Anticoagulant effect determined based on number of patients who need rescue antigoagulant and/or have clinical signs of catheter related thrombosis during the PCI procedure [ Time Frame: 14 days ]
Complete list of historical versions of study NCT00818753 on ClinicalTrials.gov Archive Site
  • 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).
the number of patients experiencing catheter related thrombotic events and or vessel closure or new thrombus or no reflow, coagulation parameters before and after study drug administration [ Time Frame: 14 days ]
Not Provided
Not Provided
 
Randomized, Open Label Study of Dabigatran Etexilate in Elective Percutaneous Coronary Intervention
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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Heart Catheterization
  • Drug: dabigatran 110 mg
    comparison of different dabigatran dosages with unfractionated heparin
  • Drug: dabigatran 150 mg
    comparison of different dabigatran dosages with unfractionated heparin
  • Drug: unfractionated heparin
    comparison of different dosages dabigatran with unfractionated heparin
  • Experimental: Dabigatran 110 mg
    experimental drug therapy in this indication
    Intervention: Drug: dabigatran 110 mg
  • Experimental: Dabigatran 150 mg
    experimental drug therapy in this indication
    Intervention: Drug: dabigatran 150 mg
  • Active Comparator: Unfractionated Heparin
    standard therapy in this indication as comparator
    Intervention: Drug: unfractionated heparin
Vranckx P, Verheugt FW, de Maat MP, Ulmans VA, Regar E, Smits P, ten Berg JM, Lindeboom W, Jones RL, Friedman J, Reilly P, Leebeek FW. A randomised study of dabigatran in elective percutaneous coronary intervention in stable coronary artery disease patients. EuroIntervention. 2013 Jan 22;8(9):1052-60. doi: 10.4244/EIJV8I9A162.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
Not Provided
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00818753
1160.73, 2007-007536-25
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP