Platelet Hyperreactivity Project (PHP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pierre Fontana, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00976196
First received: September 11, 2009
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

The PHP study aims to delineate gene products involved in high on-treatment platelet reactivity in aspirin-treated cardiovascular patients.


Condition
Platelet Reactivity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Platelet Hyperreactivity Project: A System Biology Approach of High On-treatment Platelet Reactivity in Aspirin-treated Cardiovascular Patients

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • proteome profile of platelet hyperreactivity [ Time Frame: cross sectional ] [ Designated as safety issue: No ]
    to characterize the proteome profile of platelet hyperreactivity in aspirin-treated cardiovascular patients


Secondary Outcome Measures:
  • platelet hyperreactivity phenotype in cardiovascular patients treated with aspirin [ Time Frame: cross sectional ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • genetic polymorphisms associated with platelet hyperreactivity [ Time Frame: cross sectional ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Plasma Serum Platelets


Enrollment: 110
Study Start Date: January 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Detailed Description:

The PHP study aims to delineate gene products involved in high on-treatment platelet reactivity in aspirin-treated cardiovascular patients using a system biology approach that include proteomics analysis of selected platelet sub-fractions in patients displaying extreme phenotype.

Main objective:

  • to characterize the proteome profile of platelet hyperreactivity in aspirin-treated cardiovascular patients

Secondary objectives:

  • to characterize the platelet hyperreactivity phenotype in cardiovascular patients treated with aspirin
  • to determine genetic polymorphisms associated with platelet hyperreactivity
  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

Symptomatic atherothrombotic patients treated with aspirin.

Criteria

Inclusion Criteria:

  • Documented symptomatic ischemic atherothrombotic disease treated by aspirin.

Exclusion Criteria:

  • Known platelet disorder
  • Chronic treatment by antiplatelet drugs other than aspirin
  • Chronic anticoagulant treatment
  • Chronic non steroidal anti-inflammatory drug treatment
  • Active cancer
  • Treatment with serotonin reuptake inhibitors
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00976196

Locations
Switzerland
University Hospital Geneva
Geneva, Switzerland, 1205
Sponsors and Collaborators
Pierre Fontana
Investigators
Principal Investigator: Pierre Fontana, MD, PhD University of Geneva
  More Information

No publications provided

Responsible Party: Pierre Fontana, PI, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT00976196     History of Changes
Other Study ID Numbers: 08-104
Study First Received: September 11, 2009
Last Updated: January 30, 2014
Health Authority: Switzerland: Federal Office of Public Health

Keywords provided by University Hospital, Geneva:
Aspirin
Blood platelets
proteomics
Platelet reactivity

ClinicalTrials.gov processed this record on April 17, 2014