Clinical trial NCT05493657: Aspirin vs Clopidogrel After TAVR
Official title: Aspirin Versus Clopidogrel for Leaflet Thrombosis Prevention in Patients Undergoing Transcatheter Aortic Valve Replacement: ACLO-TAVR Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Severe Aortic Stenosis
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 230
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of leaflet thrombosis
timeFrame: At 3 months after TAVR
Secondary outcomes:
measure: Any stroke
timeFrame: 3 months and 6 months after TAVR
measure: Ischemic Stroke
timeFrame: 3 months and 6 months after TAVR
measure: Transient ischemic attack
timeFrame: 3 months and 6 months after TAVR
measure: Thromboembolic events (composite of any stroke, myocardial infarction, systemic embolism (not involving the central nervous system), deep-vein thrombosis, or pulmonary embolism)
timeFrame: 3 months and 6 months after TAVR
measure: Echocardiographic parameters (maximum and mean aortic valve pressure gradient)
timeFrame: at 3 months after TAVR
measure: Echocardiographic parameters (doppler velocity index)
timeFrame: at 3 months after TAVR
measure: Echocardiographic parameters (paravalvular regurgitation)
timeFrame: at 3 months after TAVR
measure: Echocardiographic parameters (leaflet thrombosis)
timeFrame: at 3 months after TAVR
measure: VARC-3 type 3 or 4 bleeding
timeFrame: 3 months and 6 months after TAVR
measure: VARC-3 type 2 bleeding
timeFrame: 3 months and 6 months after TAVR
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
name: Young-Guk Ko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: