Single Antiplatelet Treatment With Ticagrelor or Aspirin After Transcatheter Aortic Valve Implantation: Multicenter Randomized Clinical Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,206
- Locations
- 2
- Primary Endpoint
- Safety and efficacy of Ticagrelor vs Aspirin in the incidence of NACE at 12 months after TAVI.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 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 Criteria
- •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.
Arms & Interventions
Acetylsalicylic acid 100mg/day
Aspirin 100 mg/day after TAVI
Intervention: Ticagrelor 60mg (Drug)
Ticagrelor 60mg twice per day
Ticagrelor 60 mg twice per day after TAVI
Intervention: Ticagrelor 60mg (Drug)
Outcomes
Primary Outcomes
Safety and efficacy of Ticagrelor vs Aspirin in the incidence of NACE at 12 months after TAVI.
Time Frame: 12 months
NACE is a composite of: all-cause mortality, transient ischemic attack (TIA) or stroke, myocardial infarction, progressive angina leading to emergency evaluation,rehospitalization or new coronary angiography, valve thrombosis, claudication, acute limb ischemia leading to hospitalization, any bleeding.
Secondary Outcomes
- Safety endpoint: Major bleeding(12 months)
- Efficacy endpoint: Subclinical valve thrombosis(3 and 12 months)
- Patient-oriented composite endpoints(12 months)