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

February 28, 2022 updated by: Andres Iñiguez Romo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36312
        • Hospital Alvaro Cunqueiro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Clopidogrel 75 mg

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.
ACTIVE_COMPARATOR: Ticagrelor 60 mg

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.
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.

Other Names:
  • High platelet reactivity patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of treatment in suppressing High Platelet Reactivity
Time Frame: At least 24 hours before the index-TAVI procedure
Assess the efficacy of ticagrelor 60 mg/12 hours in suppressing High Platelet Reactivity after TAVI. Platelet reactivity will be assessed by VerifyNow P2Y12.
At least 24 hours before the index-TAVI procedure
Efficacy of treatment in suppressing High Platelet Reactivity
Time Frame: 24 ± 2 hour post TAVI
Assess the efficacy of ticagrelor 60 mg/12 hours in suppressing High Platelet Reactivity after TAVI. Platelet reactivity will be assessed by VerifyNow P2Y12.
24 ± 2 hour post TAVI
Efficacy of treatment in suppressing High Platelet Reactivity
Time Frame: 30 ± 7 days post TAVI
Assess the efficacy of ticagrelor 60 mg/12 hours in suppressing High Platelet Reactivity after TAVI. Platelet reactivity will be assessed by VerifyNow P2Y12.
30 ± 7 days post TAVI
Efficacy of treatment in suppressing High Platelet Reactivity
Time Frame: 90 ± 7 days post TAVI
Assess the efficacy of ticagrelor 60 mg/12 hours in suppressing High Platelet Reactivity after TAVI. Platelet reactivity will be assessed by VerifyNow P2Y12.
90 ± 7 days post TAVI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Security: incidence of hemorrhagic complications
Time Frame: 1) At least 24 hours before the index-TAVI procedure 2) 3) 4) 5)
Evaluate the incidence of hemorrhagic complications after TAVI. As safety endpoint we will assess the incidence of investigator-reported clinical events according to VARC-2 criteria (death, myocardial infarction, stroke, TIA, acute renal injury, bleeding, vascular access-site and access-related complications), including BARC bleeding definitions. For safety endpoint, all BARC criteria, included in VARC-2 criteria will be recorded.
1) At least 24 hours before the index-TAVI procedure 2) 3) 4) 5)
Security: incidence of hemorrhagic complications
Time Frame: 24 ± 2 hour post TAVI
Evaluate the incidence of hemorrhagic complications after TAVI. As safety endpoint we will assess the incidence of investigator-reported clinical events according to VARC-2 criteria (death, myocardial infarction, stroke, TIA, acute renal injury, bleeding, vascular access-site and access-related complications), including BARC bleeding definitions. For safety endpoint, all BARC criteria, included in VARC-2 criteria will be recorded.
24 ± 2 hour post TAVI
Security: incidence of hemorrhagic complications
Time Frame: 30 ± 7 days post TAVI
Evaluate the incidence of hemorrhagic complications after TAVI. As safety endpoint we will assess the incidence of investigator-reported clinical events according to VARC-2 criteria (death, myocardial infarction, stroke, TIA, acute renal injury, bleeding, vascular access-site and access-related complications), including BARC bleeding definitions. For safety endpoint, all BARC criteria, included in VARC-2 criteria will be recorded.
30 ± 7 days post TAVI
Security: incidence of hemorrhagic complications
Time Frame: 90 ± 7 days post TAVI
Evaluate the incidence of hemorrhagic complications after TAVI. As safety endpoint we will assess the incidence of investigator-reported clinical events according to VARC-2 criteria (death, myocardial infarction, stroke, TIA, acute renal injury, bleeding, vascular access-site and access-related complications), including BARC bleeding definitions. For safety endpoint, all BARC criteria, included in VARC-2 criteria will be recorded.
90 ± 7 days post TAVI
Security: incidence of hemorrhagic complications
Time Frame: 120 ± 7 days post TAVI
Evaluate the incidence of hemorrhagic complications after TAVI. As safety endpoint we will assess the incidence of investigator-reported clinical events according to VARC-2 criteria (death, myocardial infarction, stroke, TIA, acute renal injury, bleeding, vascular access-site and access-related complications), including BARC bleeding definitions. For safety endpoint, all BARC criteria, included in VARC-2 criteria will be recorded.
120 ± 7 days post TAVI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andres Iñiguez Romo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 23, 2020

Primary Completion (ACTUAL)

February 28, 2021

Study Completion (ACTUAL)

February 28, 2022

Study Registration Dates

First Submitted

March 24, 2020

First Submitted That Met QC Criteria

April 1, 2020

First Posted (ACTUAL)

April 2, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 28, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REACTIC2019-HAC
  • 2019-004860-23 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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