Ex-Vivo Reversion of Platelet Inhibition Induced by Prasugrel

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University Hospital, Geneva
Sponsor:
Information provided by (Responsible Party):
Fanny Bonhomme, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01839968
First received: April 22, 2013
Last updated: April 24, 2013
Last verified: April 2013
  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 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Plasma


Estimated Enrollment: 36
Study Start Date: September 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01839968

Contacts
Contact: Fanny Bonhomme, MD +41795532175 fanny.bonhomme@hcuge.ch

Locations
Switzerland
University Hospital of Geneva Recruiting
Geneva, GE, Switzerland, 1205
Contact: Fanny Bonhomme, MD    +41795532175    fanny.bonhomme@hcuge.ch   
Principal Investigator: Fanny Bonhomme, MD         
Sponsors and Collaborators
University Hospital, Geneva
  More Information

No publications provided

Responsible Party: Fanny Bonhomme, MD, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01839968     History of Changes
Other Study ID Numbers: 11-117
Study First Received: April 22, 2013
Last Updated: April 24, 2013
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Blood Platelet Disorders
Hematologic Diseases
Prasugrel
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 01, 2014