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Platelet Hyperreactivity Project (PHP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00976196
First Posted: September 14, 2009
Last Update Posted: December 2, 2015
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):
Pierre Fontana, University Hospital, Geneva
  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 Pierre Fontana, University Hospital, Geneva:

Primary Outcome Measures:
  • proteome profile of platelet hyperreactivity [ Time Frame: cross sectional ]
    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 ]

Other Outcome Measures:
  • genetic polymorphisms associated with platelet hyperreactivity [ Time Frame: cross sectional ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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

Responsible Party: Pierre Fontana, PI, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT00976196     History of Changes
Other Study ID Numbers: 08-104
First Submitted: September 11, 2009
First Posted: September 14, 2009
Last Update Posted: December 2, 2015
Last Verified: December 2015

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

Additional relevant MeSH terms:
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics