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Platelet Hyperreactivity Project (PHP)

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.
 
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

Tracking Information
First Submitted Date September 11, 2009
First Posted Date September 14, 2009
Last Update Posted Date December 2, 2015
Study Start Date January 2009
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 30, 2014)
proteome profile of platelet hyperreactivity [ Time Frame: cross sectional ]
to characterize the proteome profile of platelet hyperreactivity in aspirin-treated cardiovascular patients
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00976196 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 30, 2014)
platelet hyperreactivity phenotype in cardiovascular patients treated with aspirin [ Time Frame: cross sectional ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: January 30, 2014)
genetic polymorphisms associated with platelet hyperreactivity [ Time Frame: cross sectional ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Platelet Hyperreactivity Project
Official Title Platelet Hyperreactivity Project: A System Biology Approach of High On-treatment Platelet Reactivity in Aspirin-treated Cardiovascular Patients
Brief Summary The PHP study aims to delineate gene products involved in high on-treatment platelet reactivity in aspirin-treated cardiovascular patients.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Plasma Serum Platelets
Sampling Method Non-Probability Sample
Study Population Symptomatic atherothrombotic patients treated with aspirin.
Condition Platelet Reactivity
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 30, 2014)
110
Original Estimated Enrollment
 (submitted: September 11, 2009)
100
Actual Study Completion Date January 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT00976196
Other Study ID Numbers 08-104
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pierre Fontana, University Hospital, Geneva
Study Sponsor Pierre Fontana
Collaborators Not Provided
Investigators
Principal Investigator: Pierre Fontana, MD, PhD University of Geneva
PRS Account University Hospital, Geneva
Verification Date December 2015