drugset / Trial / NCT00508924

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

NCT00508924

Phase 2 Completed 140 enrolled Tanabe Pharma Corporation
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2005-08
Primary completion
Completion
2006-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Argatroban Small molecule 15 ug/kg
Subject Argatroban Small molecule 20 ug/kg
Subject Argatroban Small molecule 25 ug/kg
Comparator Heparin Other / unclassified 70 iu/kg
Comparator Heparin Other / unclassified 100 iu/kg