A Phase 4 interventional study of Ticagrelor 60mg in Severe Aortic Valve Stenosis, Aortic Valve Stenosis and Transcatheter Aortic Valve Replacement (TAVR), sponsored by Fundacin Biomedica Galicia Sur. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Fundacin Biomedica Galicia Sur · Phase 4, Interventional, and Treatment
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.
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.
1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.
This study's planned enrollment of 1,206 is above the median of 126 across 554 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →Fundacin Biomedica Galicia Sur is the lead sponsor of 28 studies on the registry; 7 are open to participants now.
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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:
Exclusion Criteria:
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A drug or device being studied in a clinical trial.
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The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Aspirin 100 mg/day after TAVI
Drug: Ticagrelor 60mg
Ticagrelor 60 mg twice per day after TAVI
Drug: Ticagrelor 60mg
Ticagrelor 60mg BID after TAVI
Safety and efficacy of Ticagrelor vs Aspirin in the incidence of NACE at 12 months after TAVI.
NACE is a composite of: all-cause mortality, transient ischemic attack (TIA) or stroke, myocardial infarction, progressive angina leading to emergency evaluation,rehospitalization or new coronary angiography, valve thrombosis, claudication, acute limb ischemia leading to hospitalization, any bleeding.
Time frame: 12 months
Efficacy endpoint: Subclinical valve thrombosis
Detected by hypoattenuated leaflet thickening (HALT) and reduced leaflet motion(RLM) at 3 and 12 months after TAVI assessed by 4-dimensional computed tomography (4D-CT) imaging. HALT: Hypoattenuating thickening in typically meniscal configuration on one or more leaflets, with or without RLM. The extent of HALT should be described per leaflet, using a 4-tier grading scale in regard to leaflet involvement along the curvilinear contour, assuming maximum involvement at the base of the leaflet: ≤25% (limited to the base) \>25% and ≤50% \>50% and ≤75% \>75% Inconclusive for HALT: imaging with insufficient image quality or presence of artifact RLM: The extent of RLM should be described per leaflet, using a 4-tier grading scale None: no reduction in leaflet excursion \<50% reduction in leaflet excursion ≥50% reduction in leaflet excursion Immobile: immobile leaflet Inconclusive for RLM: imaging with insufficient image quality or presence of artefact
Time frame: 3 and 12 months
Safety endpoint: Major bleeding
Major bleeding (type 2, 3 and 5) at 12 months after TAVI according BARC (Bleeding Academic Research Consortium)
Time frame: 12 months
Patient-oriented composite endpoints
Patient-oriented composite endpoints (POCE) at 12 months after TAVI (POCE is a composite of all-cause mortality,TIA/stroke, myocardial infarction, progressive angina leading to emergency evaluation, rehospitalization or new coronary angiography).
Time frame: 12 months
Plan to share: No
Started Jan 2022 (actual). Primary completion is estimated for Jun 2027, 65 months after the start.
Of 24 phase 4 interventional studies under Aortic Valve Stenosis, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 70. This study's planned 65 months is above that.
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Studies of the drug tested here: Ticagrelor
Fundacin Biomedica Galicia Sur