Platelet ReactivityPHPNCT00976196
Platelet Hyperreactivity Project
An observational study of Platelet Reactivity, run by Pierre Fontana at 1 site in Switzerland.
Trial summary
The PHP study aims to delineate gene products involved in high on-treatment platelet reactivity in aspirin-treated cardiovascular patients. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Platelet Reactivity
- How many people
- 110 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2009to Jan 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Symptomatic atherothrombotic patients treated with aspirin.
Who may be able to join
- Documented symptomatic ischemic atherothrombotic disease treated by aspirin.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Platelet Reactivity
- Keywords
- Aspirin, Blood platelets, proteomics, Platelet reactivity
What is being measured
The primary outcome is the main question the study is designed to answer.
proteome profile of platelet hyperreactivity
to characterize the proteome profile of platelet hyperreactivity in aspirin-treated cardiovascular patients
Measured: cross sectional
Secondary outcomes (1)
platelet hyperreactivity phenotype in cardiovascular patients treated with aspirin
Measured: cross sectional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet ReactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fontana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pierre Fontana, University Hospital, Geneva
- Investigators
- Pierre Fontana, MD, PhD, Principal investigator, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00976196
- Sponsor's protocol ID
- 08-104
- Acronym
- PHP
- Status last verified
- Dec 2015
- First submitted
- 11 Sep 2009
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Hyperreactivity Project: A System Biology Approach of High On-treatment Platelet Reactivity in Aspirin-treated Cardiovascular Patients
- ClinicalTrials.gov ID
- NCT00976196
- Acronym / sponsor ID
- PHP / 08-104
- Conditions
- Platelet Reactivity
- Keywords
- Aspirin, Blood platelets, proteomics, Platelet reactivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Pierre FontanaUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 14 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Symptomatic atherothrombotic patients treated with aspirin.
Key inclusion criteria (1 listed)
- Documented symptomatic ischemic atherothrombotic disease treated by aspirin.
Key exclusion criteria (6 listed)
- Known platelet disorder
- Chronic treatment by antiplatelet drugs other than aspirin
- Chronic anticoagulant treatment
- Chronic non steroidal anti-inflammatory drug treatment
- Active cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
proteome profile of platelet hyperreactivity
Time frame: cross sectional
to characterize the proteome profile of platelet hyperreactivity in aspirin-treated cardiovascular patients
1 secondary outcome
platelet hyperreactivity phenotype in cardiovascular patients treated with aspirin
Time frame: cross sectional
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
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Effect of Two Weeks of Low-Dose Apixaban on Platelet Reactivity in Patients With Stable Coronary Artery Disease on Dual Antiplatelet Therapy (Aspirin and Clopidogrel)
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The Effects of Dietary Erythritol on Platelet Reactivity and Vascular Inflammation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Fontana, MD, PhD principal investigator
University of Geneva, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Platelet Reactivity, run by Pierre Fontana at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proteome profile of platelet hyperreactivity (time frame: cross sectional). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.