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Ex-Vivo Reversion of Platelet Inhibition Induced by Prasugrel

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ClinicalTrials.gov Identifier: NCT01839968
Recruitment Status : Completed
First Posted : April 25, 2013
Last Update Posted : August 19, 2014
Sponsor:
Information provided by (Responsible Party):
Fanny Bonhomme, University Hospital, Geneva

Brief Summary:
The purpose of this ex-vivo study is to estimate the optimal platelet quantity necessary to reverse the antiplatelet effects of prasugrel.

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

Study Type : Observational
Actual Enrollment : 32 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : September 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Prasugrel
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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


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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

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

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

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