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Ex-Vivo Reversion of Platelet Inhibition Induced by Prasugrel

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01839968
First Posted: April 25, 2013
Last Update Posted: August 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Fanny Bonhomme, University Hospital, Geneva
  Purpose
The purpose of this ex-vivo study is to estimate the optimal platelet quantity necessary to reverse the antiplatelet effects of prasugrel.

Condition Intervention
Acquired Platelet Disorder Other: Ex vivo addition of normal platelet rich plasma to prasugrel-treated platelet rich plasma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Fanny Bonhomme, University Hospital, Geneva:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA
Plasma

Enrollment: 32
Study Start Date: September 2011
Study Completion Date: January 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with acute coronary syndrome who received a loading dose of prasugrel within 6 and 24h.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01839968


Locations
Switzerland
University Hospital of Geneva
Geneva, GE, Switzerland, 1205
Sponsors and Collaborators
University Hospital, Geneva
  More Information

Responsible Party: Fanny Bonhomme, MD, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01839968     History of Changes
Other Study ID Numbers: 11-117
First Submitted: April 22, 2013
First Posted: April 25, 2013
Last Update Posted: August 19, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Blood Platelet Disorders
Hematologic Diseases
Prasugrel Hydrochloride
Platelet Aggregation Inhibitors