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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• Patients \>19 years old

• Patients who underwent TAVR symptomatic severe AS

• Provision of informed consent

Locations
Other Locations
Republic of Korea
Yonsei University Health System, Severance Hospital
RECRUITING
Seoul
Contact Information
Primary
Young-Guk Ko, MD, PhD
ygko@yuhs.ac
82-2-2228-8460
Time Frame
Start Date: 2023-02-02
Estimated Completion Date: 2027-07-21
Participants
Target number of participants: 230
Treatments
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.
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.
Sponsors
Leads: Yonsei University

This content was sourced from clinicaltrials.gov

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