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Platelet Reactivity After TAVI: A Multicenter Pilot Study

NCT02224066 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2018-08-03

No results posted yet for this study

Summary

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.

Conditions

  • Severe Aortic Valve Stenosis
  • Transcatheter Aortic Valve Implantation
  • Transcatheter Aortic Valve Replacement

Interventions

DRUG

Ticagrelor 90 mg twice per day during three months following TAVI

DRUG

Aspirin 100 mg plus Clopidogrel 75 mg daily during three months following TAVI

Sponsors & Collaborators

  • Hospital de Meixoeiro

    lead OTHER_GOV

Principal Investigators

  • Andrés Iñiguez Romo, MD;Phd · Xerencia de Xestión Integrada de Vigo

  • Victor A Jimenez Diaz, MD; Msc · Xerencia de Xestión Integrada de Vigo

  • Pablo Juan Salvadores, Pharma; MPH · Xerencia xestión integrada de Vigo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-05-31
Completion
2018-08-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02224066 on ClinicalTrials.gov