Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT05283356
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05283356
Study Brief:
Protocol Section:
NCT05283356