NCT05283356 Single Antiplatelet Treatment With Ticagrelor or Aspirin After Transcatheter Aortic Valve Implantation
| NCT ID | NCT05283356 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Fundacin Biomedica Galicia Sur |
| Condition | Severe Aortic Valve Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,206 participants |
| Start Date | 2022-01-21 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 1,206 participants in total. It began in 2022-01-21 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05283356 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Severe Aortic Valve Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05283356 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05283356 currently recruiting?
Yes, NCT05283356 is actively recruiting participants. Contact the research team at victor.alfonso.jimenez.diaz@sergas.es for enrollment information.
Where is the NCT05283356 trial being conducted?
This trial is being conducted at Vigo, Spain.
Who is sponsoring the NCT05283356 clinical trial?
NCT05283356 is sponsored by Fundacin Biomedica Galicia Sur. The trial plans to enroll 1,206 participants.