drugset / Trial / NCT04532333
Efficacy and Safety of Bivalirudin Versus Heparin During Coil Embolization in Patients With Ruptured Intracranial Aneurysms
Phase 3
Unknown
236 enrolled
Changhai Hospital
Qilu Hospital of Shandong University · collabThe First Affiliated Hospital of Zhengzhou University · collabThe First People's Hospital of Changzhou · collabWuhan University · collabZhejiang University · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
This is a randomized, open label, multi-center, positive-controlled study, in which a total of 236 patients will be enrolled and randomly assigned to receive bivalirudin or heparin in a 1:1 ratio during coil embolization in patients with ruptured intracranial aneurysms. Procedure-related complication, mRS, Activated Clotting Time, ischemic and hemorrhagic complications, symptomatic and asymptomatic intracranial hemorrhage, death, Heparin Induced Thrombocytopenia will be evaluated during procedure, at 24hs, 7days and 30 days after.
Timeline
- Start
- 2020-08
- Primary completion
- 2021-05
- Completion
- 2021-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bivalirudin | Peptide | 1.75 mg/kg | Intravenous |
| Comparator | Heparin | Other / unclassified | 10 mg | — |