drugset / Trial / NCT00508924
Study on Safety and Effectiveness of Three Doses of Argatroban as Anticoagulant in Percutaneous Coronary Intervention (PCI)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |