Single antiplatelet treatment with Ticagrelor or Aspirin after Transcatheter Aortic Valve Implantation: multicenter randomized clinical trial

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 1200

Inclusion 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).

Exclusion Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials

Single therapy after transcatheter aortic valve implantatio

Phase 1

Fundación Biomédica Galicia Sur

Updated 10/26/2021