Platelet REACtivity According to TICagrelor Dose After Transcatheter AorticValve Implantation (REACTIC-TAVI)

Andres Iñiguez Romo

Status and phase: Completed; Phase 4

Conditions: Symptomatic Aortic Stenosis

Treatments: Drug: Ticagrelor 60mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04331145

REACTIC2019-HAC

2019-004860-23 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Clopidogrel 75 mg

No Intervention group

Description:

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: Normal basal platelet reactivity (PRU \< 160 assessed with VerifyNow P2Y12 assay): Patients will continue with clopidogrel 75 mg/day until TAVI and during the following three months. All patients will be assessed by clinical follow up and platelet reactivity according to the protocol. Prescription of aspirin 100mg/day will be encourage as per guidelines recommendations.

Ticagrelor 60 mg

Active Comparator group

Description:

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 hrs 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 24 hours 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.

Treatment:

Drug: Ticagrelor 60mg