Using Ticagrelor or Aspirin for Patients After Aortic Valve Implantation

Single Antiplatelet Treatment With Ticagrelor or Aspirin After Transcatheter Aortic Valve Implantation: Multicenter Randomized Clinical Trial

This study tests whether Ticagrelor works better than Aspirin to prevent blood clots and complications in adults with severe aortic stenosis after they have a heart valve replacement.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1206 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fundacin Biomedica Galicia Sur (Academic / other)
• Locations: 1 site (Vigo, Pontevedra)
• Trial ID: NCT05283356 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of single antiplatelet therapy with Ticagrelor compared to Aspirin in patients who have undergone transcatheter aortic valve implantation (TAVI). The study aims to determine the optimal pharmacological treatment to prevent valve thrombosis and reduce the risk of thromboembolic complications while minimizing bleeding risks. It focuses on adult patients with severe aortic stenosis and specific comorbidities, such as diabetes or coronary artery disease, who are eligible for TAVI. The trial will assess the outcomes related to ischemic complications and overall patient safety.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old with symptomatic severe aortic stenosis who are scheduled for TAVI and have comorbidities like diabetes or coronary artery disease.

Not a fit: Patients who do not have severe aortic stenosis or those who are not undergoing TAVI may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective antiplatelet therapy option for patients undergoing TAVI, potentially reducing complications and improving outcomes.

How similar studies have performed: Other studies have explored antiplatelet therapies in TAVI populations, but this specific comparison of Ticagrelor and Aspirin is novel and untested.

Eligibility criteria

Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures.
2. Adult patients (more than 18 years) with ability to understand and accept the participation in the clinical trial.
3. Patients with degenerative symptomatic severe aortic stenosis (AS) accepted for TAVI with any of the commercial approved TAVI devices after evaluation of the Heart Team of each center,and with at least one of the following comorbidities:

   1. Diabetes Mellitus, the current WHO diagnostic criteria for diabetes should be maintained - fasting plasma glucose ≥ 7.0mmol/l (126 mg/dl) or 2-h plasma glucose ≥ 11.1mmol/l (200mg/dl), or under treatment with an oral hypoglycemic or insulin.
   2. Prior coronary artery disease (STEMI, NSTEMI, stable angina, or others) documented by invasive or non-invasive ischemia screening tests or imaging study.
   3. Prior peripheral arterial disease documented by invasive or non-invasive ischemia screening tests or imaging study.
4. Successful TAVI performed by any vascular access.
5. Patients who are not participating in any other clinical trial or research study (registries allowed).

Exclusion Criteria:

1. Patients under chronic oral anticoagulation for any specific pathology.
2. Patients that cannot undergo a regimen of single antiplatelet therapy after TAVI.
3. History of overt major bleeding or intracranial hemorrhage.
4. Active pathological bleeding.
5. History of ischemic stroke within the last 30 days prior TAVI.
6. Patients with documented severe hepatic insufficiency.
7. Known pregnancy, breast-feeding, or intend to become pregnant during the study period.
8. Concomitant oral or intravenous therapy with potent inhibitors of cytochrome P450 3A (CYP3A) that cannot be suspended during the study.
9. Patients randomized in another clinical trial with an investigational product or device over the past 30 days.
10. Patients who cannot attend follow-up visits scheduled in the study.
11. History of allergic reactions or intolerance to Ticagrelor or Aspirin or any of the excipients.

Where this trial is running

Vigo, Pontevedra

• Hospital Alvaro Cunqueiro — Vigo, Pontevedra, Spain (Recruiting)

Study contacts

• Study coordinator: Victor A Jiménez Díaz, MD, MPH

Conditions Severe Aortic Valve Stenosis; Aortic Valve Stenosis; Transcatheter Aortic Valve Replacement; Transcatheter Aortic Valve Implantation; Transcatheter aortic valve replacement; Transcatheter aortic valve implantation; Single antiplatelet therapy; Ticagrelor 60 mg