Platelet Hyperreactivity Project | NCT00976196

Studies
Platelet Hyperreactivity Project

NCT00976196

Sponsor

Pierre Fontana

Status

Completed

Last Update Posted

Dec 2, 2015Estimated

Enrollment

110Actual

Phase

Not provided

Conditions

Platelet Reactivity

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Jan 2010Actual

Completion Date

Jan 2010Actual

First Submitted Date

Sep 11, 2009

First Submission Date that Met QC Criteria

Sep 11, 2009

First Posted Date

Sep 14, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2015

Last Update Posted Date

Dec 2, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

110Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
proteome profile of platelet hyperreactivity	to characterize the proteome profile of platelet hyperreactivity in aspirin-treated cardiovascular patients	cross sectional

Secondary Outcomes

Measure	Description	Time Frame
platelet hyperreactivity phenotype in cardiovascular patients treated with aspirin		cross sectional

Other Outcomes

Measure	Description	Time Frame
genetic polymorphisms associated with platelet hyperreactivity		cross sectional

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Symptomatic atherothrombotic patients treated with aspirin.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pierre Fontana, MD, PhD	University of Geneva, Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Geneva		Geneva		1205	Switzerland