Platelet Dysfunction Due to Aspirin IngestionNCT01915407
AggreGuide 325 mg. Aspirin Study for Aspirin Induced Platelet Dysfunction
An observational study of Platelet Dysfunction Due to Aspirin Ingestion, run by Aggredyne, Inc. at 1 site in United States.
Trial summary
To test the AggreGuide A-100 AA Assay's effectiveness for detecting aspirin induced platelet dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Platelet Dysfunction Due to Aspirin Ingestion
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Jul 2013
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: aspirin naïve subjects over 18
Who may be able to join
- over 18
Who cannot join
- on aspirin in prior week
- medical history of platelet disorders
- contraindications to aspirin
Trial locations and contacts
1 site in 1 country.
About this study
To test the AggreGuide A-100 AA Assay's effectiveness for detecting aspirin induced platelet dysfunction.
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet Activity Index (PAI) before and after ingestion of aspirin
PAI is the proprietary reporting unit of the Aggreguide. It is related to the amount of platelet aggregation in the sample of whole blood.
Measured: 2 - 30 hours post aspirin ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet Dysfunction Due to Aspirin IngestionStudies 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
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aggredyne, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915407
- Sponsor's protocol ID
- AGD 051
- Status last verified
- Aug 2013
- First submitted
- 30 Jul 2013
- Last updated
- 2 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AggreGuide 325 mg. Aspirin Study for Aspirin Induced Platelet Dysfunction
- ClinicalTrials.gov ID
- NCT01915407
- Acronym / sponsor ID
- AGD 051
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Aggredyne, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 2 Aug 2013 (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.
To test the AggreGuide A-100 AA Assay's effectiveness for detecting aspirin induced platelet dysfunction.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- aspirin naïve subjects over 18
Key inclusion criteria (1 listed)
- over 18
Key exclusion criteria (3 listed)
- on aspirin in prior week
- medical history of platelet disorders
- contraindications to aspirin
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
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.
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 Aug 2013.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Dysfunction Due to Aspirin Ingestion, run by Aggredyne, Inc. at 1 site in United States.
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 3 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 Aug 2013. 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 United States. 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?
Platelet Activity Index (PAI) before and after ingestion of aspirin (time frame: 2 - 30 hours post aspirin ingestion). 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 Aug 2013.