Clinical Trial: Study on Safety and Effectiveness of Three Doses of Argatroban as Anticoagulant in Percutaneous Coronary Intervention (PCI)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomised, Open, Parallel-group, Multicentre Study to Examine the Safety and Effectiveness of Three Doses of Argatroban as Anticoagulant in Combination With Clopidogrel and Aspirin in Patients Unde

Brief Summary: This is a phase II multi-centre study in 140 patients undergoing elective PCI to obtain the information on dose-response of argatroban in pharmacodynamic markers and to assess the anticoagulation, safety and efficacy of argatroban in reference to unfractionated heparin, in combination with dual antiplatelet therapy.

Detailed Summary: This is a phase II multi-centre study in Europe in patients with stable coronary artery disease or troponin negative unstable angina undergoing elective PCI, to obtain the information on the safety and effects on various pharmacodynamic markers, of three doses of argatroban in combination with clopidogrel and aspirin, and to assess the results of argatroban and unfractionated heparin, both used in combination with clopidogrel and aspirin, on clinical outcomes, adequacy of anticoagulation, various pharmacodynamic markers (approximately 35 patients per group).
Sponsor: Mitsubishi Tanabe Pharma Corporation

Current Primary Outcome:

  • Activated Clotting Time (ACT) Value After the First Dosing of Study Treatment. [ Time Frame: 5 - 10 min after initial bolus ]
  • Composite and Each of Death, Myocardial Infarction, and Urgent Revascularisation at Day 30, and Major Bleeding Events During Hospital Stay. [ Time Frame: 30 Days ]

    Composite end point (a): all cause death, myocardial infarction and urgent revascularization at Day30

    Composite end point (b): all cause death, myocardial infarction and urgent revascularization at Day30 as well as major bleeding events during hospital stay



Original Primary Outcome:

  • Activated Clotting Time (ACT) Value After the First Dosing of Study Treatment.
  • Composite and Each of Death, Myocardial Infarction, and Urgent Revascularisation at Day 30, and Major Bleeding Events During Hospital Stay.
  • Minor bleeding events during hospital stay.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Mitsubishi Tanabe Pharma Corporation

Dates:
Date Received: July 26, 2007
Date Started: August 2005
Date Completion:
Last Updated: November 6, 2012
Last Verified: November 2012