NCT04331145

Platelet REACtivity According to TICagrelor Dose After Transcatheter AorticValve Implantation

REACTIC-TAVI Trial: Platelet REACtivity According to TICagrelor Dose After Transcatheter AorticValve Implantation. A Pilot Study.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Andres Iñiguez Romo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Symptomatic Aortic Stenosis

Interventions

Type	Name	Description
DRUG	Ticagrelor 60mg	Platelet reactivity will be assessed by VerifyNow P2Y12 assay in ALL enrolled patients after confirmed use of clopidogrel for 4 days prior TAVI. Patients that have not completed a pre-treatment period of 4 days of clopidogrel will receive a loading dose of 300mg, according to the clinical practice, with assessment of platelet reactivity by VerifyNow P2Y12 at the following 6 hours. Based on results of basal VerifyNow P2Y12 assay at least 24 hours before the index-TAVI procedure, patients with: High on-treatment platelet reactivity (PRU ≥ 160 assessed with VerifyNow P2Y12 assay): Patients will be switched to receive ticagrelor 60mg twice daily initiating at least 24hrs before TAVI procedure, in order to arrive to the index TAVI procedure with at least two doses of 60 mg, and will continue with Ticagrelor 60mg twice per day during the following three months.

Timeline

• Start date: 2020-06-23
• Primary completion: 2021-02-28
• Completion: 2022-02-28
• First posted: 2020-04-02
• Last updated: 2022-03-02

Locations

1 site across 1 country: Spain