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

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
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: 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 September 30, 2014