Platelet Reactivity After TAVI: A Multicenter Pilot Study (REAC-TAVI)

August 1, 2018 updated by: Andres Iñiguez Romo, MD, PhD, Hospital de Meixoeiro

Assessment of Platelet REACtivity After Transcatheter Aortic Valve Implantation

A high platelet reactivity in patients with severe symptomatic Aortic Stenosis (AS) selected for TAVI (Transcatheter aortic valve implantation) procedure has been demonstrated previously, and the use of double antiaggregation therapy (DAPT) with Clopidogrel and Acetylsalicylic acid (ASA) do not achieve consistent and adequate suppression of platelet reactivity. The purpose of this study is evaluate the efficacy of ticagrelor alone versus DAPT with clopidogrel and aspirin for the suppression of high platelet reactivity following TAVI.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

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
      • Barcelona, Spain, 08026
        • Hospital Santa Creu i Sant Creu
      • Granada, Spain, 18014
        • Hospital Virgen de las Nieves
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Murcia, Spain, 30120
        • Hospital Universitario Virgen de La Arrixaca
      • Salamanca, Spain, 37007
        • Hospital Universitario de Salamanca
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Clinic Universitari Bellvitge
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36312
        • Hospital Universitario Álvaro 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:

For inclusion in the study subjects should fulfill the following criteria:

  1. Provision of informed consent prior to any study specific procedures.
  2. Adult patients (more than 18 years) with ability to understand and accept the participation in the clinical trial.
  3. Patients with degenerative symptomatic severe AS accepted for TAVI after evaluation of the Heart Team of each center.
  4. Patients who are not participating in any other clinical trial or research study (registries allowed).

Exclusion Criteria:

Subjects should not enter the study if any of the following exclusion criteria are fulfilled:

  1. Recent stroke <14 days prior to TAVI, non-revascularized severe coronary or carotid artery disease (>70% stenosis) or life expectancy < 12 months
  2. Patients under chronic oral anticoagulation
  3. Patients with proven allergy to aspirin, clopidogrel or ticagrelor
  4. Patients that after TAVI cannot undergo a regimen of single or dual antiplatelet therapy for 3 months due to a new post-TAVI medical indication
  5. Known pregnancy or breast-feeding
  6. Concomitant oral or intravenous therapy with potent inhibitors of cytochrome P450 3A (CYP3A) that cannot be suspended during the course of the study. Medications considered as potent inhibitors are: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin (or erythromycin but not astromicin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and more than a daily liter of grapefruit juice.
  7. Thrombocytopenia (<50,000 platelets U/L) well documented and clinically relevant.
  8. Patients with documented moderate or severe hepatic insufficiency
  9. Any condition that may put the patient at risk or influence the outcome of the trial
  10. Patients previously randomized in this trial or in another clinical trial with an investigational product or device over the past 30 days.
  11. Patients who cannot attend follow up visits scheduled in the study

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ticagrelor
Patients with high-on-treatment platelet reactivity (PRU ≥ 208)
Drug: Ticagrelor 90 mg twice per day during three months following TAVI
Active Comparator: Aspirin/Clopidogrel
Patients with high-on-treatment platelet reactivity (PRU ≥ 208)
Drug: Aspirin 100 mg plus Clopidogrel 75 mg daily during three months following TAVI
No Intervention: Registry arm
Patients with normal-on-treatment platelet reactivity (PRU < 208) will continue with Aspirin 100 mg plus Clopidogrel 75 mg daily during three months following TAVI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate the effectiveness of ticagrelor compared to clopidogrel and aspirin for the suppression of residual platelet reactivity by a system to verify the patient's platelet reactivity (VerifyNow P2Y12 assay).
Time Frame: Three months after antiplatelet treatment initiation following procedure.
Three months after antiplatelet treatment initiation following procedure.

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate the effectiveness of ticagrelor compared to clopidogrel and aspirin for the suppression of residual platelet reactivity by VerifyNow P2Y12 assay.
Time Frame: Six hours after antiplatelet treatment initiation following procedure.
Six hours after antiplatelet treatment initiation following procedure.

Other Outcome Measures

Outcome Measure
Time Frame
Assess the safety of antiplatelet monotherapy with ticagrelor compared to DAPT with aspirin and clopidogrel, with regard to the incidence of investigator-reported clinical events according to predefined criteria, including bleeding definitions.
Time Frame: Three months after antiplatelet treatment initiation following procedure.
Three months after antiplatelet treatment initiation following procedure.

Collaborators and Investigators

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

Sponsor

Hospital de Meixoeiro

Investigators

  • Principal Investigator: Andrés Iñiguez Romo, MD;Phd, Xerencia de Xestión Integrada de Vigo
  • Principal Investigator: Victor A Jimenez Diaz, MD; Msc, Xerencia de Xestión Integrada de Vigo
  • Study Director: Pablo Juan Salvadores, Pharma; MPH, Xerencia xestión integrada de Vigo

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)

January 1, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

August 21, 2014

First Submitted That Met QC Criteria

August 21, 2014

First Posted (Estimate)

August 25, 2014

Study Record Updates

Last Update Posted (Actual)

August 3, 2018

Last Update Submitted That Met QC Criteria

August 1, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEIX-VALV-002
  • REAC TAVI (Other Identifier: 201401)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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