Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04532333
Status:
UNKNOWN
Last Update Posted:
2020-08-31
First Post:
2020-08-26
Brief Title:
Efficacy and Safety of Bivalirudin Versus Heparin During Coil Embolization in Patients With Ruptured Intracranial Aneurysms
Sponsor:
Changhai Hospital
Organization:
Changhai Hospital
Study Overview
Official Title:
Anticoagulant Efficacy and Safety of BivalirUdin Versus heparIn During coiL Embolization in Patients With ruptureD Intracranial Aneurysms an Open-label Multicenter Randomized Pilot StudyBUILD
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BUILD
Brief 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 11 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
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
Detailed Description:
Endovascular embolization has become an effective modality for the treatment of intracranial aneurysms Despite advances in technology and techniques thromboembolic and bleeding events are still encountered as inherent perioperative complications Hypercoagulability as a systemic response to acute subarachnoid hemorrhage SAH may be associated with an increased incidence of thromboembolic events
The administration of anticoagulant may reduce thromboembolic events during the endovascular embolization meanwhile involves the risk of bleeding Although heparin is commonly used during the procedure the safety in patients with ruptured intracranial aneurysms has not been established In contrast to heparin bivalirudin is a short-lived direct thrombin inhibitor with an intrinsic antiplatelet activity and more stable pharmacokinetic and pharmacodynamic properties which has been associated with reduced bleeding and an overall favorable profile Bivalirudin administration in patients with high bleeding risk during coronary intervention is recommended by current guidelines
This is an open label multicenter randomized pilot study which is aimed to investigate the safety and efficacy of bivalirudin coil embolization in patients with ruptured intracranial aneurysms
The administration of anticoagulant may reduce thromboembolic events during the endovascular embolization meanwhile involves the risk of bleeding Although heparin is commonly used during the procedure the safety in patients with ruptured intracranial aneurysms has not been established In contrast to heparin bivalirudin is a short-lived direct thrombin inhibitor with an intrinsic antiplatelet activity and more stable pharmacokinetic and pharmacodynamic properties which has been associated with reduced bleeding and an overall favorable profile Bivalirudin administration in patients with high bleeding risk during coronary intervention is recommended by current guidelines
This is an open label multicenter randomized pilot study which is aimed to investigate the safety and efficacy of bivalirudin coil embolization in patients with ruptured intracranial aneurysms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None