NCT02112539

Brief Summary

The study is to characterize the AggreGuide ADP Assay's performance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2014

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

March 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 14, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

April 4, 2017

Status Verified

April 1, 2017

Enrollment Period

5 months

First QC Date

April 10, 2014

Last Update Submit

April 2, 2017

Conditions

Platelet AggregationADP Blockers

Outcome Measures

Primary Outcomes (1)

  • Platelet Activity Index (PAI)

    PAI at baseline and after taking ADP blocking antiplatelet drugs.

    1 week

Study Arms (1)

ADP Blockers

platelet aggregation in response to antiplatelet drugs

Other: platelet aggregation measurement

Interventions

platelet aggregation measurementOTHER
ADP Blockers

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

community sample

You may not qualify if:

  • less than 60 kg
  • on antiplatelet meds other than aspirin
  • antiplatelet drugs contraindicated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Juno Research

Houston, Texas, 77036, United States

Location

MeSH Terms

Interventions

Platelet Aggregation

Intervention Hierarchy (Ancestors)

HemorheologyBlood Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaPlatelet ActivationHemostasis

Study Officials

  • Edward Teitel, MD

    Unafilliated

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2014

First Posted

April 14, 2014

Study Start

March 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

April 4, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)