Platelet REACtivity According to TICagrelor Dose After Transcatheter AorticValve Implantation

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The narrowing of the aortic valve, which prevents blood from reaching the entire body correctly is a common disease in our environment. To correct this problem, many patients undergo Transcatheter Aortic Valve Implantation (TAVI) according to standard clinical practice. Patients have to continue with a specific pharmacological treatment (antiplatelet agents) to avoid possible complications during the first months after the procedure. This treatment is not yet well established. Current guidelines recommend dual antiplatelet therapy with Aspirin and Clopidogrel for 3-6 months after TAVI to avoid thromboembolic complications. But the risk of bleeding events with DAPT in this population is not negligible.

This study aims to determine the degree of response to Ticagrelor 60 mg every 12 hours as a single antiplatelet strategy in patients who do not achieve an adequate response with Clopidogrel 75mg every 24 hours. The study will evaluate if patients have an adequate response to Clopidogrel and if not, then patients will start treatment with Ticagrelor 60 mg every 12 hours after TAVI and until completing 3 months of treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Andres Iñiguez Romo
• Treatments: Clopidogrel; Ticagrelor

Criteria

Inclusion Criteria:

• Diagnosed with severe symptomatic aortic stenosis

• Accepted for transfemoral TAVI by a Heart Team decision

• Evaluation of platelet reactivity assessed by VerifyNow® assay prior TAVI

Exclusion Criteria:

• Contraindication to TAVI

• TAVI performed by a different access route than transfemoral

• Ned for oral anticoagulation therapy

• History of intracranial hemorrhage

• Ischemic stroke the 14 days before TAVI

• Active pathological bleeding or diathesis

• Moderate to severe hepatic impairment

• Use of strong CYP34A inhibitors or inducers

• Contraindications to DAPT for 3 months

• Contraindication to clopidogrel or ticagrelor

• Platelet count <50,000

• Pregnancy or breastfeeding