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Completed

NCT Number: NCT04331145

Platelet REACtivity According to TICagrelor Dose After Transcatheter AorticValve Implantation

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.

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Key information

Conditions

Symptomatic Aortic Stenosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Alvaro Cunqueiro

Vigo, Pontevedra, 36312, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ticagrelor 60mg

Drug

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Andres Iñiguez Romo

Other

Registry information

Official study title

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

Acronym: REACTIC-TAVI

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Apr 2, 2020
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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