Ex-Vivo Reversion of Platelet Inhibition Induced by Prasugrel

August 18, 2014 updated by: Fanny Bonhomme, University Hospital, Geneva
The purpose of this ex-vivo study is to estimate the optimal platelet quantity necessary to reverse the antiplatelet effects of prasugrel.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

32

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

  • Switzerland
    • GE
      • Geneva, GE, Switzerland, 1205
        • University Hospital of Geneva

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

Sampling Method

Non-Probability Sample

Study Population

Patients with acute coronary syndrome who received a loading dose of prasugrel within 6 and 24h.

Description

Inclusion Criteria:

  • Acute coronary syndrome
  • Prasugrel loading dose 6-24h before inclusion

Exclusion Criteria:

  • Clopidogrel loading dose
  • GPIIbIIIa use within 10 days before inclusion
  • Known congenital thrombopathy and/or congenital coagulation defect

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study patients
Acute coronary syndrome patients with a recent loading dose of prasugrel (6-24h)
Other: Ex vivo addition of normal platelet rich plasma to prasugrel-treated platelet rich plasma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Platelet reactivity assessed by light transmittance aggregometry (LTA) after ex-vivo normal platelet addition
Time Frame: within the first 6-24 hours after antiplatelet drug loading dose
within the first 6-24 hours after antiplatelet drug loading dose

Collaborators and Investigators

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

Sponsor

University Hospital, Geneva

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

September 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

April 22, 2013

First Submitted That Met QC Criteria

April 24, 2013

First Posted (Estimate)

April 25, 2013

Study Record Updates

Last Update Posted (Estimate)

August 19, 2014

Last Update Submitted That Met QC Criteria

August 18, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-117

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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