Aspirin vs Clopidogrel After TAVR

Severe Aortic Stenosis Clinical Trial

Official title:

Aspirin Versus Clopidogrel for Leaflet Thrombosis Prevention in Patients Undergoing Transcatheter Aortic Valve Replacement: ACLO-TAVR Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05493657
• Other study ID #: 4-2022-0744
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2023
• Est. completion date: July 2025

Study information

• Verified date: October 2023
• Source: Yonsei University
• Contact: Young-Guk Ko, MD, PhD
• Phone: 82-2-2228-8460
• Email: ygko[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: July 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Patients >19 years old

2. Patients who underwent TAVR symptomatic severe AS

3. Provision of informed consent

Exclusion Criteria:

1. Patients requiring dual antiplatelet therapy longer than 4 weeks

2. Any conditions requiring specific antiplatelet therapy aspirin or clopidogrel

3. History of stroke or transient ischemic attack (TIA) within 6 months

4. Planned major surgery

5. Cardiogenic shock or hemodynamic instability

6. Chronic kidney disease stage 4 or 5 (eGFR <30mL/min)

7. Valve-in-valve TAVR procedure

8. Hypersensitivity or contraindication to aspirin or clopidogrel

9. Indication for anticoagulation therapy

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Severe Aortic Stenosis

Intervention

Drug:
• Aspirin single antiplatelet therapy
Patients receive the aspirin (100 mg/day) single antiplatelet therapy after 4 weeks of dual antiplatelet therapy of aspirin (100 mg/day) and clopidogrel (75 mg/day) after TAVR.
• Clopidogrel single antiplatelet therapy
Patients receive the clopidogrel (75 mg/day) single antiplatelet therapy after 4 weeks of dual antiplatelet therapy of aspirin (100 mg/day) and clopidogrel (75 mg/day) after TAVR.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of leaflet thrombosis	Incidence of leaflet thrombosis on cardiac CT at 3 months after TAVR	At 3 months after TAVR
Secondary	Any stroke		3 months and 6 months after TAVR
Secondary	Ischemic Stroke		3 months and 6 months after TAVR
Secondary	Transient ischemic attack		3 months and 6 months after TAVR
Secondary	Thromboembolic events (composite of any stroke, myocardial infarction, systemic embolism (not involving the central nervous system), deep-vein thrombosis, or pulmonary embolism)		3 months and 6 months after TAVR
Secondary	Echocardiographic parameters (maximum and mean aortic valve pressure gradient)		at 3 months after TAVR
Secondary	Echocardiographic parameters (doppler velocity index)		at 3 months after TAVR
Secondary	Echocardiographic parameters (paravalvular regurgitation)		at 3 months after TAVR
Secondary	Echocardiographic parameters (leaflet thrombosis)		at 3 months after TAVR
Secondary	VARC-3 type 3 or 4 bleeding		3 months and 6 months after TAVR
Secondary	VARC-3 type 2 bleeding		3 months and 6 months after TAVR