Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06238115
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-01-17
Brief Title:
Tirofiban for Reduction of Thromboembolic Events in Endovascular Unruptured Aneurysm Repair
Sponsor:
Beijing Tiantan Hospital
Organization:
Beijing Tiantan Hospital
Study Overview
Official Title:
Prophylactic Administration of Tirofiban for Preventing Thromboembolic Events in Stent-assisted Coiling and Flow Diversion Treatments of Unruptured Intracranial Aneurysms
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
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:
TEAR
Brief Summary:
To explore whether administering tirofiban in stent-assisted coilingflow diverting treatments for participants with unruptured intracranial aneurysms can reduce new ischemic lesions on postoperative DWI sequences compared to conventional dual antiplatelet therapy
Detailed Description:
This is a single-center open-label assessor-blinded randomized controlled trial Participants with stent-assisted coilingflow diverting for unruptured intracranial aneurysms will be enrolled and randomized into two groups Tirofiban group-after femoral artery puncture initial infusion of 04μgkg body weightminute over 30 minutes followed by a continuous infusion of 01μgkg body weightminute for 24 hours Meanwhile routine dual antiplatelet therapy aspirin 100 mgday clopidogrel 75 mgday will be administered Placebo group-100 mgday aspirin and 75 mgday clopidogrel The primary effectiveness endpoint is the numbers and volumes of ischemic lesions on diffusion weighted imaging DWI within 48 hours after procedure
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