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

REACTIC-TAVI TRIAL: Platelet REACtivity according to TICagrelor dose after Trancathter Aortic Valve Implantation. A pilot study. - Ticagrelor 60 mg BID after TAVI

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004860-23-ES

Enrollment

Registered

2020-03-06

Start date

2020-05-22

Completion date

Unknown

Last updated

2022-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with severe aortic stenosis submitted for Transcatheter Aortic Valve Implantation

Interventions

Trade Name: Ticagrelor Pharmaceutical Form: Tablet INN or Proposed INN: Ticagrelor Other descriptive name: TICAGRELOR Concentration unit: mg milligram(s) Concentration type: equal Concentration number

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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: 2. In-Hospital after TAVI: at 24 ± 2hrs 3. Out-of-Hospital follow-up visits : at 30 ± 7 days at 90 ± 7 days at 120 ± 7 days	—

Measure

Time frame

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: 2. In-Hospital after TAVI: at 24 ± 2hrs 3. Out-of-Hospital follow-up visits : at 30 ± 7 days at 90 ± 7 days at 120 ± 7 days

—

Secondary

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

Countries

Spain

Contacts

Public ContactPablo Juan Salvadores

Hospital Alvaro Cunqueiro

pablo.juan@iisgaliciasur.es34986825564

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026