Aspirin vs Clopidogrel After TAVR

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

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.

Study Overview

• Status: Recruiting
• Conditions: Severe Aortic Stenosis
• Intervention / Treatment: Drug: Aspirin single antiplatelet therapy; Drug: Clopidogrel single antiplatelet therapy

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

• Study Type: Interventional
• Enrollment (Estimated): 254
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Young-Guk Ko, MD, PhD; Phone Number: 82-2-2228-8460; Email: ygko@yuhs.ac

Study Locations

• South Korea
  • Seoul, South Korea
    • Recruiting
    • Yonsei University Health System, Severance Hospital
    • Contact: Young-Guk Ko, MD, PhD; Phone Number: 82-2-2228-8460; Email: ygko@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aspirin group; 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.	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.
Experimental: Clopidogrel group; 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of leaflet thrombosis	Incidence of leaflet thrombosis on cardiac CT at 3 months after TAVR	At 3 months after TAVR

Secondary Outcome Measures

Outcome Measure	Time Frame
Any stroke	3 months and 6 months after TAVR
Ischemic Stroke	3 months and 6 months after TAVR
Transient ischemic attack	3 months and 6 months after TAVR
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
Echocardiographic parameters (maximum and mean aortic valve pressure gradient)	at 3 months after TAVR
Echocardiographic parameters (doppler velocity index)	at 3 months after TAVR
Echocardiographic parameters (paravalvular regurgitation)	at 3 months after TAVR
Echocardiographic parameters (leaflet thrombosis)	at 3 months after TAVR
VARC-3 type 3 or 4 bleeding	3 months and 6 months after TAVR
VARC-3 type 2 bleeding	3 months and 6 months after TAVR

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Young-Guk Ko, MD, PhD, Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2023
• Primary Completion (Estimated): July 21, 2026
• Study Completion (Estimated): July 21, 2027

Study Registration Dates

• First Submitted: August 8, 2022
• First Submitted That Met QC Criteria: August 8, 2022
• First Posted (Actual): August 9, 2022

Study Record Updates

• Last Update Posted (Estimated): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 4, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Aspirin; Clopidogrel
• Other Study ID Numbers: 4-2022-0744

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No