- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01915407
AggreGuide 325 mg. Aspirin Study for Aspirin Induced Platelet Dysfunction
August 1, 2013 updated by: Aggredyne, Inc.
To test the AggreGuide A-100 AA Assay's effectiveness for detecting aspirin induced platelet dysfunction.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
150
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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Texas
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Houston, Texas, United States, 77099
- Aggredyne, Inc.
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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 and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
aspirin naïve subjects over 18
Description
Inclusion Criteria:
- over 18
Exclusion Criteria:
- on aspirin in prior week
- medical history of platelet disorders
- contraindications to aspirin
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 |
---|---|---|
Platelet Activity Index (PAI) before and after ingestion of aspirin
Time Frame: 2 - 30 hours post aspirin ingestion
|
PAI is the proprietary reporting unit of the Aggreguide.
It is related to the amount of platelet aggregation in the sample of whole blood.
|
2 - 30 hours post aspirin ingestion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
April 1, 2013
Primary Completion (ACTUAL)
July 1, 2013
Study Completion (ACTUAL)
July 1, 2013
Study Registration Dates
First Submitted
July 30, 2013
First Submitted That Met QC Criteria
August 1, 2013
First Posted (ESTIMATE)
August 2, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
August 2, 2013
Last Update Submitted That Met QC Criteria
August 1, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AGD 051
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.
Clinical Trials on Platelet Dysfunction Due to Aspirin Ingestion
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Cardiff UniversityCompletedPlatelet Dysfunction Due to AspirinUnited Kingdom
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George Washington UniversityCompletedPlatelet Dysfunction Due to AspirinUnited States
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Hamilton Health Sciences CorporationUnknownAspirin | Platelet Dysfunction Due to Drugs | Ticagrelor | TransfusionCanada
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The University of The West IndiesCompletedPlatelet Dysfunction Due to DrugsTrinidad and Tobago
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The University of The West IndiesRecruiting
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Northwell HealthWithdrawnPlatelet Dysfunction Due to Drugs
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The University of The West IndiesCompletedPlatelet Dysfunction Due to DrugsTrinidad and Tobago
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Aggredyne, Inc.CompletedRisk Factor, Cardiovascular | Platelet Dysfunction Due to Drugs
-
IRCCS Policlinico S. DonatoCompletedBleeding | Platelet Dysfunction Due to DrugsItaly
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Scientific Institute San RaffaeleUniversità Vita-Salute San RaffaeleRecruitingThrombosis | Blood Coagulation Disorder | Platelet Thrombus | Platelet Dysfunction Due to Aspirin | Failure;VentricularItaly