Status:
UNKNOWN
Single Antiplatelet Treatment With Ticagrelor or Aspirin After Transcatheter Aortic Valve Implantation
Lead Sponsor:
Fundacin Biomedica Galicia Sur
Conditions:
Severe Aortic Valve Stenosis
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 o...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- Patients under chronic oral anticoagulation for any specific pathology.
- 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.
- Known pregnancy, breast-feeding, or intend to become pregnant during the study period.
- 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.
- 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.
Key Trial Info
Start Date :
January 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
1206 Patients enrolled
Trial Details
Trial ID
NCT05283356
Start Date
January 21 2022
End Date
June 30 2025
Last Update
March 31 2022
Active Locations (1)
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1
Hospital Alvaro Cunqueiro
Vigo, Pontevedra, Spain, 36312