Single Antiplatelet Treatment With Ticagrelor or Aspirin After Transcatheter Aortic Valve Implantation
Key facts
- Who runs it
- Fundacin Biomedica Galicia Sur
- Where
- Catania, San Donato Milanese, and Verona, ItalySee the 3 sitesAlso in 2 other countries, 32 sites
- 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
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
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 Italy
Also in 2 other countries, 32 sites
- Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di CataniaCatania, ItalyTaking people
- Policlinico San Donato S.p.A.San Donato Milanese, ItalyTaking people
- Azienda Ospedaliera Universitaria Integrata VeronaVerona, ItalyTaking people
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.
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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
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData 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
- Record updated
- 28 July 2026