Using Ticagrelor or Aspirin for Patients After Aortic Valve Implantation

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 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.

Why it matters

Who can join: the full rules

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 it's running

• Hospital Alvaro Cunqueiro
  Vigo, Pontevedra, Spain Recruiting

Study contacts

• Study coordinator: Victor A Jiménez Díaz, MD, MPH
• Email: victor.alfonso.jimenez.diaz@sergas.es
• Phone: +34986825564

Similar studies

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

• CHATEAU Registry: Real-world outcomes after TAVR

  This registry collects real-world data from adults who had TAVR between 2021 and 2025 to see how they do over time and how valve performance holds up.

  Recruiting Eunpyeong St. Mary's Hospital · Seoul · NCT07709858

• Hydra THV Transfemoral Valve Implantation in Severe Aortic Stenosis

  This registry tests how safely and effectively the Hydra THV works when implanted through the femoral artery in adults with severe symptomatic aortic stenosis.

  Recruiting at 8 sites Fundación EPIC · Aravaca and 7 other locations · NCT07566624

• How the type of sedation affects recovery after TAVR

  This study will test whether three common sedation approaches (propofol, dexmedetomidine, or midazolam with fentanyl) change how people recover on the first day after transfemoral TAVR.

  Recruiting Phase 4 Endeavor Health · Glenview, Illinois · NCT07556523

• Using 4D Flow MRI to characterize left ventricular failure

  This project will test whether automated 4D Flow MRI analysis can measure left ventricular dysfunction in adults with severe aortic stenosis who are scheduled for TAVR.

  Recruiting at 2 sites IRCCS Policlinico S. Donato · San Donato Milanese and 1 other locations · NCT07455292

• Tracking progression and consequences of heart valve disease

  This project will follow adults with moderate or worse valve disease to see if clinical tests and imaging can predict when their condition will get worse.

  Recruiting at 15 sites Second Affiliated Hospital, Zhejiang University, School of Medicine · Fuzhou, Fujian and 14 other locations · NCT07267117

• Evaluation of the Point-Guard device during heart valve replacement

  This study is testing a new device called Point-Guard to see if it can help prevent brain problems during heart valve replacement surgery.

  Recruiting Transverse Medical, Inc. · Clayton, Victoria · NCT06962371

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.