- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00976196
Platelet Hyperreactivity Project (PHP)
December 1, 2015 updated by: Pierre Fontana
Platelet Hyperreactivity Project: A System Biology Approach of High On-treatment Platelet Reactivity in Aspirin-treated Cardiovascular Patients
The PHP study aims to delineate gene products involved in high on-treatment platelet reactivity in aspirin-treated cardiovascular patients.
Study Overview
Status
Completed
Conditions
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
Enrollment (Actual)
110
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Geneva, Switzerland, 1205
- University Hospital Geneva
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Symptomatic atherothrombotic patients treated with aspirin.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
proteome profile of platelet hyperreactivity
Time Frame: cross sectional
|
to characterize the proteome profile of platelet hyperreactivity in aspirin-treated cardiovascular patients
|
cross sectional
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
platelet hyperreactivity phenotype in cardiovascular patients treated with aspirin
Time Frame: cross sectional
|
cross sectional
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
genetic polymorphisms associated with platelet hyperreactivity
Time Frame: cross sectional
|
cross sectional
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Pierre Fontana, MD, PhD, University of Geneva
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
January 1, 2010
Study Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
September 11, 2009
First Submitted That Met QC Criteria
September 11, 2009
First Posted (Estimate)
September 14, 2009
Study Record Updates
Last Update Posted (Estimate)
December 2, 2015
Last Update Submitted That Met QC Criteria
December 1, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 08-104
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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