NCT00976196

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

December 2, 2015

Status Verified

December 1, 2015

Enrollment Period

1 year

First QC Date

September 11, 2009

Last Update Submit

December 1, 2015

Conditions

Platelet Reactivity

Keywords

AspirinBlood plateletsproteomicsPlatelet reactivity

Outcome Measures

Primary Outcomes (1)

  • proteome profile of platelet hyperreactivity

    to characterize the proteome profile of platelet hyperreactivity in aspirin-treated cardiovascular patients

    cross sectional

Secondary Outcomes (1)

  • platelet hyperreactivity phenotype in cardiovascular patients treated with aspirin

    cross sectional

Other Outcomes (1)

  • genetic polymorphisms associated with platelet hyperreactivity

    cross sectional

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Symptomatic atherothrombotic patients treated with aspirin.

You may qualify if:

  • Documented symptomatic ischemic atherothrombotic disease treated by aspirin.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Geneva

Geneva, 1205, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma Serum Platelets

Study Officials

  • Pierre Fontana, MD, PhD

    University of Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

September 11, 2009

First Posted

September 14, 2009

Study Start

January 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

December 2, 2015

Record last verified: 2015-12

Locations

CH(1)