Comparing aspirin and clopidogrel after heart valve replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to determine the best antithrombotic therapy following transcatheter aortic valve replacement (TAVR) for patients with severe aortic stenosis. It is a prospective, multicenter, open-label, randomized controlled trial where eligible patients will be assigned to receive either aspirin or clopidogrel monotherapy after an initial period of dual antiplatelet therapy. The primary focus is to assess the incidence of leaflet thrombosis using cardiac CT and echocardiography at three months post-TAVR. Patients will be monitored clinically for six months to evaluate outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Yonsei University Health System, Severance Hospital
  Seoul, South Korea Recruiting

Study contacts

• Principal investigator: Young-Guk Ko, MD, PhD — Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
• Study coordinator: Young-Guk Ko, MD, PhD
• Email: ygko@yuhs.ac
• Phone: 82-2-2228-8460

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Registry of Transcatheter Aortic Valve Treatments at a Italian Center

  This registry tests how safe and effective transcatheter valve procedures are in adults with severe aortic stenosis treated at a single Italian center.

  Recruiting Fondazione IRCCS Policlinico San Matteo di Pavia · Pavia, Pavia · NCT07596394

• CT-FFR-guided revascularization for people with severe aortic stenosis

  This study will see if adding CT-FFR (a noninvasive blood-flow test) to preoperative CT angiography helps doctors decide whether people with severe aortic stenosis need coronary revascularization before valve replacement.

  Recruiting Yan'an Affiliated Hospital of Kunming Medical University · Kunming, Yunnan · NCT07469371

• RENATUS transcatheter aortic valve for severe aortic stenosis

  This trial tests the RENATUS transcatheter aortic valve in people with symptomatic severe aortic stenosis who are eligible for TAVR.

  Recruiting at 4 sites Beijing Balance Medical Technology Co., Ltd · Beijing and 3 other locations · NCT07414342

• Pre-emptive LAVA-ECMO support for complex, high-risk TAVR

  The team will try pre-emptive left atrial veno-arterial ECMO to stabilize adults with severe aortic stenosis undergoing complex, high-risk TAVR who are unstable or at risk of instability.

  Recruiting at 2 sites Atlantic Health System · Detroit, Michigan and 1 other locations · NCT07309029

• Comparing the DurAVR transcatheter heart valve with SAPIEN and Evolut valves for severe aortic stenosis

  This trial will test whether the DurAVR transcatheter heart valve works as well and is as safe as SAPIEN or Evolut valves in people with severe calcific aortic stenosis, and it also includes a registry for people needing valve‑in‑valve procedures.

  Recruiting Anteris Technologies Ltd. · Copenhagen, Capital Region of Denmark · NCT07194265

• Navitor TAVI valve in Japanese patients with severe aortic stenosis

  This study will try the Navitor transcatheter aortic valve with the FlexNav delivery system in about 100 Japanese adults with symptomatic severe aortic stenosis to track safety and how well the valve works.

  Recruiting at 3 sites Abbott Medical Devices · Fukuoka and 2 other locations · NCT07193888

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.