Aspirin vs Clopidogrel After TAVR

Sponsor
Yonsei University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05493657
Collaborator
(none)
230
1
2
33.5
6.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Aspirin single antiplatelet therapy
  • Drug: Clopidogrel single antiplatelet therapy
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
230 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Aspirin Versus Clopidogrel for Leaflet Thrombosis Prevention in Patients Undergoing Transcatheter Aortic Valve Replacement: ACLO-TAVR Trial
Anticipated Study Start Date :
Sep 15, 2022
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Incidence of leaflet thrombosis [At 3 months after TAVR]

    Incidence of leaflet thrombosis on cardiac CT at 3 months after TAVR

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yonsei University Health System, Severance Hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • Yonsei University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yonsei University
ClinicalTrials.gov Identifier:
NCT05493657
Other Study ID Numbers:
  • 4-2022-0744
First Posted:
Aug 9, 2022
Last Update Posted:
Aug 9, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 9, 2022