REACTIC-TAVI TRIAL: Platelet REACtivity according to TICagrelor dose after Trancathter Aortic Valve Implantation. A pilot study.

Phase 1

• Conditions: Patients with severe aortic stenosis submitted for Transcatheter Aortic Valve Implantation; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2019-004860-23-ES
• Lead Sponsor: Andres Iñiguez Romo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-06
• Last Update Posted: 9 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

- >18 years old
- Diagnosed with severe aortic stenosis
- High and/or intermediate surgery risk based on current risk scores
- Ruled in by a Heart Team decision
- Without previous dual antiplatelet therapy
- Plaqueted reactivity made by VerifyNow® assays in whom has been treated with Clopidogrel
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

- Contraindication to TAVI
- Atrial Fibrillation (which needs oral anticoagulation)
- Oral anticoagulation
- 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
- Use of ISRS (Paroxetina, Sertralina, Citalopram)
- Contraindications to DAPT for 3 months
- Contraindication to Aspirin, clopidogrel or ticagrelor
- Platelet count <50.000
- Pregnancy or breastfeeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The efficacy of available dose of Ticagrelor 60 mg/12h in suppressing high platelet reactivity after TAVI.;Secondary Objective: The incidence of hemorrhagic complications;Primary end point(s): Assess the efficacy of ticagrelor 60 mg/12h in suppressing HPR after TAVI;Timepoint(s) of evaluation of this end point: 1. Pre-TAVI:<br>2. In-Hospital after TAVI: at 24 ± 2hrs <br>3. Out-of-Hospital follow-up visits : <br> at 30 ± 7 days <br> at 90 ± 7 days <br> at 120 ± 7 days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Evaluate the incidence of hemorrhagic complications after TAVI.;Timepoint(s) of evaluation of this end point: 1. Pre-TAVI<br>2. In-Hospital after TAVI: at 24 ± 2hrs <br>3. Out-of-Hospital follow-up visits : <br> at 30 ± 7 days <br> at 90 ± 7 days <br> at 120 ± 7 days