drugset / Trial / NCT04046029
Bivalirudin in Elderly Patients Undergoing Elective Percutaneous Coronary Intervention.
Phase 4
Unknown
240 enrolled
The First Affiliated Hospital of Dalian Medical University
Beijing Friendship Hospital · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
The study is an investigator-sponsored, prospective, multicenter, randomized, open-label study designed to compare efficacy and safety between bivalirudin and heparin in elderly patients with acute coronary syndrome undergoing elective percutaneous coronary intervention.
Timeline
- Start
- 2019-07-08
- Primary completion
- 2020-07-30
- Completion
- 2021-06-30
Publications
- Background De Caterina R, Husted S, Wallentin L, Andreotti F, Arnesen H, Bachmann F, Baigent C, Huber K, Jespersen J, Kristensen SD, Lip GY, Morais J, Rasmussen LH, Siegbahn A, Verheugt FW, Weitz JI; European Society of Cardiology Working Group on Thrombosis Task Force on Anticoagulants in Heart Disease. Parenteral anticoagulants in heart disease: current status and perspectives (Section II). Position paper of the ESC Working Group on Thrombosis-Task Force on Anticoagulants in Heart Disease. Thromb Haemost. 2013 May;109(5):769-86. doi: 10.1160/TH12-06-0403. Epub 2013 Mar 28.
- Background Hirsh J, Anand SS, Halperin JL, Fuster V; American Heart Association. AHA Scientific Statement: Guide to anticoagulant therapy: heparin: a statement for healthcare professionals from the American Heart Association. Arterioscler Thromb Vasc Biol. 2001 Jul;21(7):E9-9. doi: 10.1161/hq0701.093520. No abstract available.
- Background Robson R, White H, Aylward P, Frampton C. Bivalirudin pharmacokinetics and pharmacodynamics: effect of renal function, dose, and gender. Clin Pharmacol Ther. 2002 Jun;71(6):433-9. doi: 10.1067/mcp.2002.124522.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bivalirudin | Peptide | 1.75 mg/kg | — |
| Comparator | Heparin | Other / unclassified | 50 iu/kg | — |
| Comparator | Heparin | Other / unclassified | 70 iu/kg | — |
| Comparator | Heparin | Other / unclassified | 100 iu/kg | — |