Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT07205250
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-03
First Post:
2025-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aspirin for Stroke Prevention After Endovascular Aortic Arch Repair: A Multicenter, Double-Blind, Randomized Controlled Trial
Sponsor:
Wei Wu
Organization:
Study Overview
Official Title:
WesternTheaterCommand
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
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:
None
Brief Summary:
Abstract Introduction: Endovascular aortic arch repair (EAAR) and endovascular reconstruction of arch branch vessels have emerged as a new trend in treating aortic arch pathologies due to their advantages of minimal invasiveness, faster recovery, and fewer complications. Stroke is a common and severe complication during EAAR procedures; however, preventive strategies and the necessity of postoperative antiplatelet therapy remain unreported.
Methods and analysis: This project aims to conduct a prospective, multicenter, double-masked randomized controlled study. Patients undergoing EAAR will be randomly assigned to either an aspirin or a placebo group, receiving six months of aspirin or placebo treatment postoperatively. Both groups will be followed up for over one year, with the primary outcome being the incidence of postoperative stroke. Secondary outcomes include the patency rate of reconstructed branch vessels, the incidence of major bleeding complications, EAAR-related complications, and postoperative cognitive impairment. The study will evaluate the efficacy and safety of aspirin in preventing stroke after EAAR.
Furthermore, through stratified analysis, the study will explore the impact of different reconstruction techniques, the number of reconstructed branch arteries, and the diameter of branch stents on postoperative stroke rates. It will also assess the value of aspirin in different subgroups, aiming to provide more precise clinical strategies for prevention and treatment.
Ethics and dissemination:（Mandatory pre-implementation review by the Institutional Review Board (IRB) of Western Theater Command General Hospital ensures full compliance with national ethical standards and regulatory requirements.
All research personnel must adhere strictly to ethical principles and assume full accountability for protecting participant rights and monitoring ongoing safety. The trial's results will be disseminated through academic conferences and journal publications.
Methods and analysis: This project aims to conduct a prospective, multicenter, double-masked randomized controlled study. Patients undergoing EAAR will be randomly assigned to either an aspirin or a placebo group, receiving six months of aspirin or placebo treatment postoperatively. Both groups will be followed up for over one year, with the primary outcome being the incidence of postoperative stroke. Secondary outcomes include the patency rate of reconstructed branch vessels, the incidence of major bleeding complications, EAAR-related complications, and postoperative cognitive impairment. The study will evaluate the efficacy and safety of aspirin in preventing stroke after EAAR.
Furthermore, through stratified analysis, the study will explore the impact of different reconstruction techniques, the number of reconstructed branch arteries, and the diameter of branch stents on postoperative stroke rates. It will also assess the value of aspirin in different subgroups, aiming to provide more precise clinical strategies for prevention and treatment.
Ethics and dissemination:（Mandatory pre-implementation review by the Institutional Review Board (IRB) of Western Theater Command General Hospital ensures full compliance with national ethical standards and regulatory requirements.
All research personnel must adhere strictly to ethical principles and assume full accountability for protecting participant rights and monitoring ongoing safety. The trial's results will be disseminated through academic conferences and journal publications.
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?: