Single Antiplatelet Treatment With Ticagrelor or Aspirin After Transcatheter Aortic Valve Implantation (REAC-TAVI2)

  • STATUS
    Recruiting
  • End date
    Jun 30, 2025
  • participants needed
    1206
  • sponsor
    Fundacin Biomedica Galicia Sur
Updated on 24 April 2022
diabetes
stenosis
insulin
ischemia
transcatheter aortic valve implantation
tavi

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 periand 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.

Details
Condition Severe Aortic Valve Stenosis, Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement (TAVR), Transcatheter Aortic Valve Implantation (TAVI)
Treatment Ticagrelor 60mg
Clinical Study IdentifierNCT05283356
SponsorFundacin Biomedica Galicia Sur
Last Modified on24 April 2022

Eligibility

Yes No Not Sure

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
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