Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-01 @ 6:28 PM
Study NCT ID:
NCT05493657
Status:
RECRUITING
Last Update Posted:
2024-10-15
First Post:
2022-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aspirin vs Clopidogrel After TAVR
Sponsor:
Yonsei University
Organization:
Study Overview
Official Title:
Aspirin Versus Clopidogrel for Leaflet Thrombosis Prevention in Patients Undergoing Transcatheter Aortic Valve Replacement: ACLO-TAVR Trial
Status:
RECRUITING
Status Verified Date:
2024-10
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:
Currently, the optimal antithrombotic therapy after transcatheter aortic valve replacement (TAVR) remains still unknown., The purpose of the study is to compare aspirin versus clopidogrel monoantiplatelet therapy for preventive effect on leaflet thrombosis in patients undergoing TAVR for severe aortic stenosis. This study is designed as a prospective, multicenter, open label, randomized controlled study. Eligible patients will be randomized to aspirin or clopidogrel monotherapy after TAVR. Patients will have dual antiplatelet therapy of aspirin 100 mg and clopidogrel 75 mg for 4 weeks after TAVR and then subsequent monoantiplatelet therapy of either aspirin 100 mg or clopidogrel 75 mg according to the randomization. Leaflet thrombosis will be assessed with cardiac computed tomography (CT) and transthoracic echocardiography at 3 months after TAVR. Patients will be clinically followed for 6 months. The primary endpoint is the Incidence of leaflet thrombosis on cardiac CT at 3 months.
Detailed Description:
1. Prospective, multicenter, open label, randomized controlled study
2. Eligible patients will be randomized to aspirin or clopidogrel monotherapy after TAVR
3. All patients will have dual antiplatelet therapy of aspirin 100 mg and clopidogrel 75 mg for 4 weeks after TAVR and then subsequent monoantiplatelet therapy of either aspirin 100 mg or clopidogrel 75 mg.
4. Leaflet thrombosis will be assessed with cardiac computed tomography (CT) and transthoracic echocardiography at 3 months after TAVR
5. Clinical follow-up up to 6 months
2. Eligible patients will be randomized to aspirin or clopidogrel monotherapy after TAVR
3. All patients will have dual antiplatelet therapy of aspirin 100 mg and clopidogrel 75 mg for 4 weeks after TAVR and then subsequent monoantiplatelet therapy of either aspirin 100 mg or clopidogrel 75 mg.
4. Leaflet thrombosis will be assessed with cardiac computed tomography (CT) and transthoracic echocardiography at 3 months after TAVR
5. Clinical follow-up up to 6 months
Study Oversight
Has Oversight DMC:
True
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?: