Platelet AggregationNCT02112539
Aggreguide A-100 ADP Assay Evaluation
An observational study of Platelet Aggregation and ADP Blockers, run by Aggredyne, Inc. at 1 site in United States.
Trial summary
The study is to characterize the AggreGuide ADP Assay's performance. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Platelet Aggregation, ADP Blockers
- What is being tested?
- platelet aggregation measurement
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Aug 2014
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: community sample
Who may be able to join
- 18-75
Who cannot join
- less than 60 kg
- on antiplatelet meds other than aspirin
- antiplatelet drugs contraindicated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pivotal Study of the AggreGuide A-100 Adenosine Diphosphate (ADP) Assay to Evaluate the Effect of ADP Blocking Drugs on Platelet Aggregation on the AggreGuide A-100 Instrument
The study is to characterize the AggreGuide ADP Assay's performance.
- Conditions
- Platelet Aggregation, ADP Blockers
- Being tested
- platelet aggregation measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet aggregation measurementOther
| Study group | Role | What they receive |
|---|---|---|
| ADP Blockers | platelet aggregation in response to antiplatelet drugs Receives: Other: platelet aggregation measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet Activity Index (PAI)
PAI at baseline and after taking ADP blocking antiplatelet drugs.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet AggregationStudies 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
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aggredyne, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward Teitel, MD, Principal investigator, Unafilliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112539
- Sponsor's protocol ID
- Val 0072-B
- Status last verified
- Apr 2017
- First submitted
- 10 Apr 2014
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Study of the AggreGuide A-100 Adenosine Diphosphate (ADP) Assay to Evaluate the Effect of ADP Blocking Drugs on Platelet Aggregation on the AggreGuide A-100 Instrument
- ClinicalTrials.gov ID
- NCT02112539
- Acronym / sponsor ID
- Val 0072-B
- Conditions
- Platelet Aggregation, ADP Blockers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Aggredyne, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 14 Apr 2014 (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.
The study is to characterize the AggreGuide ADP Assay's performance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADP Blockers | – | Other: platelet aggregation measurementplatelet aggregation in response to antiplatelet drugs |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- community sample
Key inclusion criteria (1 listed)
- 18-75
Key exclusion criteria (3 listed)
- less than 60 kg
- on antiplatelet meds other than aspirin
- antiplatelet drugs contraindicated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| platelet aggregation measurement | Other | ADP Blockers |
Primary outcome
Platelet Activity Index (PAI)
Time frame: 1 week
PAI at baseline and after taking ADP blocking antiplatelet drugs.
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 4 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Edward Teitel, MD principal investigator
Unafilliated
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 Aggregation and ADP Blockers, 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 4 Apr 2017. 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) (time frame: 1 week). 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 4 Apr 2017.