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Single antiplatelet treatment with Ticagrelor or Aspirin after Transcatheter Aortic Valve Implantation: multicenter randomized clinical trial
EU CTIS ID: 2023-509290-22-00
What this study is testing
Assessment of the safety and efficacy of Ticagrelor vs Aspirin in the incidence of Net Adverse Clinical Event (NACE) at 12 months after TAVI.NACE is a composite of: 1. All-cause mortality 2. Transient ischemic attack (TIA) or stroke 3. Myocardial infarction 4. Progressive angina leading to emergency evaluation, rehospitalization or new coronary angiography 5. Valve thrombosis 6. Claudication 7. Acute limb ischemia leading to hospitalization 8. Any bleeding
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 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 (126mg/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).
You likely can't join if
- Patients under chronic oral anticoagulation for any specific pathology
- Patients who cannot attend follow-up visits scheduled in the study.
- History of allergic reactions or intolerance to Ticagrelor or Aspirin or any of the excipients.
- Patients that cannot undergo a regimen of single antiplatelet therapy after TAVI
- History of overt major bleeding or intracranial hemorrhage
- Active pathological bleeding
See the full eligibility criteria
- 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 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 (126mg/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).
- Patients under chronic oral anticoagulation for any specific pathology
- Patients who cannot attend follow-up visits scheduled in the study.
- History of allergic reactions or intolerance to Ticagrelor or Aspirin or any of the excipients.
- Patients that cannot undergo a regimen of single antiplatelet therapy after TAVI
- History of overt major bleeding or intracranial hemorrhage
- Active pathological bleeding
- History of ischemic stroke within the last 30 days prior TAVI
- Patients with documented severe hepatic insufficiency
- For female participants, the participant must not be pregnant or lactating and must be of non-childbearing potential, confirmed at screening & eligibility visit by one of the following: (a) Postmenopausal, defined as amenorrhea for ≥ 12 months following cessation of all exogenous hormonal treatments, and with luteinizing hormone and follicle stimulating hormone levels in the postmenopausal range. (b) Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy. Tubal ligation is not considered a irreversible surgical sterilization
- Concomitant oral or intravenous therapy with potent inhibitors of cytochrome P450 3A (CYP3A) that cannot be suspended during the study. Section 13.1 Ticagrelor Overdose: any dose over the clinically intended dose.
- Patients randomized in another clinical trial with an investigational product or device over the past 30 days
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.