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Taking peoplePhase 4

Ticagrelor or aspirin alone after transcatheter aortic valve implantation for aortic stenosis

Compares ticagrelor with aspirin in people with severe aortic stenosis after valve implantation.

Key facts

Who runs it
Fundacin Biomedica Galicia Sur
Where
Coimbra, Évora, Lisbon, Porto, and Vila Nova de Gaia, PortugalSee the 6 sitesAlso in 2 other countries, 29 sites
Registry title
Single Antiplatelet Treatment With Ticagrelor or Aspirin After Transcatheter Aortic Valve Implantation
Status
Recruiting
Phase
Phase 4
People taking part
1,206 people, planned
Started
21 Jan 2022
Expected to end
30 Jun 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Ticagrelor 60mg
Record updated
28 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with severe aortic stenosis (a narrowed heart valve) who have had a successful TAVI valve procedure. They must also have diabetes, coronary artery disease or peripheral arterial disease.

Age
Over 18 years
Sex
All sexes
Disease stage
Severe aortic stenosis that causes symptoms and comes from wear of the valve. The Heart Team must accept the person for TAVI. They need at least one of: diabetes, prior coronary artery disease, or prior peripheral arterial disease.
Earlier treatment
A successful TAVI through any blood vessel access. People taking long-term blood thinners by mouth (oral anticoagulants) cannot join.
Biomarker or test result
Diabetes can be shown by fasting plasma glucose ≥ 7.0mmol/l (126 mg/dl), 2-h plasma glucose ≥ 11.1mmol/l (200mg/dl), or by taking diabetes pills or insulin.

Main reasons for not taking part

  • Long-term oral anticoagulation, or unable to take a single antiplatelet drug after TAVI
  • Past major bleeding, bleeding in the brain, or bleeding now
  • Ischemic stroke within 30 days before TAVI
  • Severe liver failure
  • Pregnancy, breastfeeding, or plans to become pregnant; allergy or intolerance to Ticagrelor or Aspirin

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • Provision of informed consent prior to any study specific procedures
  • Adult patients (more than 18 years) with ability to understand and accept the participation in the clinical trial
  • 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:; 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; Prior coronary artery disease (STEMI, NSTEMI, stable angina, or others) documented by invasive or non-invasive ischemia screening tests or imaging study; Prior peripheral arterial disease documented by invasive or non-invasive ischemia screening tests or imaging study
  • Successful TAVI performed by any vascular access
  • Patients who are not participating in any other clinical trial or research study (registries allowed)

Who cannot take part

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

Where in Portugal

Also in 2 other countries, 29 sites

  • Unidade Local de Saúde de Coimbra, E.P.E.Coimbra, PortugalNot yet recruiting
  • Unidade Local De Saude Do Alentejo Central E.P.E.Évora, PortugalNot yet recruiting
  • Unidade Local De Saude De Santa Maria E.P.E.Lisbon, PortugalNot yet recruiting
  • Unidade Local De Saude De Sao Jose E.P.E.Lisbon, PortugalNot yet recruiting
  • University Of PortoPorto, PortugalNot yet recruiting
  • Unidade Local de Saúde de Gaia/Espinho, E. P. EVila Nova de Gaia, PortugalNot yet recruiting

About the trial

What the trial wants to find out

The optimal pharmacological therapy after transcatheter aortic valve implantation (TAVI) to prevent valve thrombosis and reduce thromboembolic complications without significantly increasing the risk of bleeding is not yet fully defined and constitutes an important unmet clinical need. Recently, single antiplatelet therapy (SAPT) with Aspirin has been increasingly adopted to avoid bleeding early after TAVI compared with dual antiplatelet therapy. However, TAVI population is affected by a diversity of chronic pathologies that increase the risk of post-TAVI ischemic complications. Stroke is prevalent, especially peri- and early post-TAVI (<1-8% in the 1st year). Although peri-TAVI myocardial infarction (MI) is rare (1-3%), concomitant coronary artery disease (CAD), diabetes mellitus (DM), and peripheral vascular disease (PVD), is very frequent in the TAVI population, affecting around 30-70% of patients. In patients with CAD, the need to re-access the coronary arteries after TAVI is challenging and can be hampered by the trancatheter valve struts.

Read full original descriptionShow less

This is critical in TAVI patients with an acute coronary syndrome and in younger patients with long-life expectancy after TAVI. The use of a P2Y12 inhibitor provides significant ischemic protection in the in the coronary, cerebral and peripheral vascular territories compare to Aspirin. The use of a P2Y12 inhibitor as antiplatelet treatment can decrease the need for new coronary revascularizations and reduce the incidence of thromboembolic complications after TAVI.

The 2 groups in the trial

  • Acetylsalicylic acid 100mg/dayExisting treatment, for comparison

    Aspirin 100 mg/day after TAVI

    Treatment: Ticagrelor 60mg

  • Ticagrelor 60mg twice per dayTreatment being tested

    Ticagrelor 60 mg twice per day after TAVI

    Treatment: Ticagrelor 60mg

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
Single Antiplatelet Treatment With Ticagrelor or Aspirin After Transcatheter Aortic Valve Implantation: Multicenter Randomized Clinical Trial
Plain-language title
Ticagrelor or aspirin alone after transcatheter aortic valve implantation for aortic stenosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
28 July 2026