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Platelet Hyperreactivity Project (PHP)

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ClinicalTrials.gov Identifier: NCT00976196
Recruitment Status : Completed
First Posted : September 14, 2009
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):
Pierre Fontana, University Hospital, Geneva

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

Condition or disease
Platelet Reactivity

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

Study Type : Observational
Actual Enrollment : 110 participants
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
Study Start Date : January 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010



Primary Outcome Measures :
  1. 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 :
  1. platelet hyperreactivity phenotype in cardiovascular patients treated with aspirin [ Time Frame: cross sectional ]

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

Biospecimen Retention:   Samples With DNA
Plasma Serum Platelets


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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

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

Responsible Party: Pierre Fontana, PI, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT00976196     History of Changes
Other Study ID Numbers: 08-104
First Posted: September 14, 2009    Key Record Dates
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