Risk Factor, CardiovascularNCT03111420
Study of AggreGuide A-100 (ADP) Assay
A study testing P2Y12 inhibitor and Platelet function test in people with Risk Factor, Cardiovascular and Platelet Dysfunction Due to Drugs, run by Aggredyne, Inc..
Trial summary
Study to evaluate the performance of the AggreGuide A-100 ADP assay for detection of platelet dysfunction caused by P2Y12 inhibitor antiplatelet therapy. Read more about this study
- Who is it for?
- Ages 22 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Risk Factor, Cardiovascular, Platelet Dysfunction Due to Drugs
- What is being tested?
- P2Y12 inhibitor and Platelet function test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- 9 Jan 2017to Jun 2018
- Phase
- Interventional
- 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 22 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject has a history of cardiovascular disease OR
- Subject has 2 or more cardiac risk factors:
- Smoking
- Hypertension
- Hyperlipidemia
- Family History of Heart Disease
Show all 10Show fewer
- Post-menopausal female
- Diabetes
- Obesity (BMI > 30)
- Sedentary lifestyle
Who cannot join
- Taken nonsteroidal anti-inflammatory drugs (NSAIDs) drugs, anti-platelet drugs or anticoagulant drugs within the past seven (7) days, over age 75, under 60 kg body weight, in the last trimester of pregnancy or breastfeeding, with a diagnosed history of: stroke or transient ischemic attacks, or other thromboembolic disease, anemia, thrombocytopenia, uncontrolled hypertension,platelet disorders,hemophilia or other bleeding disorder, gastrointestinal disease, severe renal disease, expect to engage in contact sports, scheduled for elective surgery, have a medical history as determined by the Investigator that would pose safety concerns, or possess contraindications for any of the study medications.
About this study
Official title: Pivotal Study of the AggreGuide A-100 Adenosine Diphosphate (ADP) Assay to Evaluate the Detection of Platelet Dysfunction Due to P2Y12 Antiplatelet Drugs
Study to evaluate the performance of the AggreGuide A-100 ADP assay for detection of platelet dysfunction caused by P2Y12 inhibitor antiplatelet therapy.
Read the detailed description
Study subjects will have A-100 ADP measurements performed at baseline and after initiation of P2Y12 inhibitor antiplatelet therapy, following loading and maintenance doses.
- Being tested
- P2Y12 inhibitor, Platelet function test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P2Y12 inhibitorDrug
Also called clopidogrel, prasugrel, ticagrelor
Administration of P2Y12 inhibitor antiplatelet therapy
Platelet function testDevice
Also called AggreGuide A-100 ADP assay
Blood is drawn for testing of platelet aggregation activity
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel | Experimental | Platelet function test before and after administration of P2Y12 inhibitor antiplatelet therapy after ASA 81 mg.
Loading dose day 1. Maintenance dose over subsequent 7 days. Receives: Drug: P2Y12 inhibitor; Device: Platelet function test |
| Prasugrel | Experimental | Platelet function test before and after administration of P2Y12 inhibitor antiplatelet therapy after ASA 81 mg.
Loading dose day 1. Maintenance dose over subsequent 7 days. Receives: Drug: P2Y12 inhibitor; Device: Platelet function test |
| Ticagrelor | Experimental | Platelet function test before and after administration of P2Y12 inhibitor antiplatelet therapy after ASA 81 mg.
Loading dose day 1. Maintenance dose over subsequent 7 days. Receives: Drug: P2Y12 inhibitor; Device: Platelet function test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Platelet Activity Index (PAI)
Platelet reactivity measurement using A-100 ADP assay
Measured: Baseline, day 1, day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start9 Jan 2017
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Risk Factor, CardiovascularStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aggredyne, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Phil Speros, Study director, Aggredyne, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111420
- Sponsor's protocol ID
- VAL-0085
- Status last verified
- May 2018
- First submitted
- 2 Apr 2017
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Gurbel PA, Tantry US, Bliden KP, Fisher R, Sukavaneshvar S, Dahlen J, Speros PC. Clinical validation of AggreGuide A-100 ADP, a novel assay for assessing the antiplatelet effect of oral P2Y12 antagonists. J Thromb Thrombolysis. 2021 Jul;52(1):272-280. doi: 10.1007/s11239-021-02498-0. Epub 2021 Jun 18.
PubMed 34143384
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. 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 Detection of Platelet Dysfunction Due to P2Y12 Antiplatelet Drugs
- ClinicalTrials.gov ID
- NCT03111420
- Acronym / sponsor ID
- VAL-0085
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Aggredyne, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jan 2017 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 12 Apr 2017 (actual)
- 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.
Study to evaluate the performance of the AggreGuide A-100 ADP assay for detection of platelet dysfunction caused by P2Y12 inhibitor antiplatelet therapy.
Detailed description
Study subjects will have A-100 ADP measurements performed at baseline and after initiation of P2Y12 inhibitor antiplatelet therapy, following loading and maintenance doses.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel | Experimental | Drug: P2Y12 inhibitor, Device: Platelet function testPlatelet function test before and after administration of P2Y12 inhibitor antiplatelet therapy after ASA 81 mg. Loading dose day 1. Maintenance dose over subsequent 7 days. |
| Prasugrel | Experimental | Drug: P2Y12 inhibitor, Device: Platelet function testPlatelet function test before and after administration of P2Y12 inhibitor antiplatelet therapy after ASA 81 mg. Loading dose day 1. Maintenance dose over subsequent 7 days. |
| Ticagrelor | Experimental | Drug: P2Y12 inhibitor, Device: Platelet function testPlatelet function test before and after administration of P2Y12 inhibitor antiplatelet therapy after ASA 81 mg. Loading dose day 1. Maintenance dose over subsequent 7 days. |
Who may qualify
- Ages
- 22 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject has a history of cardiovascular disease OR
- Subject has 2 or more cardiac risk factors:
Key exclusion criteria (1 listed)
- Taken nonsteroidal anti-inflammatory drugs (NSAIDs) drugs, anti-platelet drugs or anticoagulant drugs within the past seven (7) days, over age 75, under 60 kg body weight, in the last trimester of pregnancy or breastfeeding, with a diagnosed history of: stroke or transient ischemic attacks, or other thromboembolic disease, anemia, thrombocytopenia, uncontrolled hypertension,platelet disorders,hemophilia or other bleeding disorder, gastrointestinal disease, severe renal disease, expect to engage in contact sports, scheduled for elective surgery, have a medical history as determined by the Investigator that would pose safety concerns, or possess contraindications for any of the study medications.
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 |
|---|---|---|
| P2Y12 inhibitorAlso: clopidogrel, prasugrel, ticagrelorAdministration of P2Y12 inhibitor antiplatelet therapy | Drug | Clopidogrel, Prasugrel, Ticagrelor |
| Platelet function testAlso: AggreGuide A-100 ADP assayBlood is drawn for testing of platelet aggregation activity | Device | Clopidogrel, Prasugrel, Ticagrelor |
Primary outcome
Change in Platelet Activity Index (PAI)
Time frame: Baseline, day 1, day 7
Platelet reactivity measurement using A-100 ADP assay
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 21 Feb 2019.
- Derived from this study: PubMed 34143384Gurbel PA, Tantry US, Bliden KP, Fisher R, Sukavaneshvar S, Dahlen J, Speros PC. Clinical validation of AggreGuide A-100 ADP, a novel assay for assessing the antiplatelet effect of oral P2Y12 antagonists. J Thromb Thrombolysis. 2021 Jul;52(1):272-280. doi: 10.1007/s11239-021-02498-0. Epub 2021 Jun 18.
- 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.
Phil Speros study director
Aggredyne, Inc.
Questions about this trial
What is this clinical trial studying?
A study testing P2Y12 inhibitor and Platelet function test in people with Risk Factor, Cardiovascular and Platelet Dysfunction Due to Drugs, run by Aggredyne, Inc..
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 10 inclusion and 1 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 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in Platelet Activity Index (PAI) (time frame: Baseline, day 1, day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03111420, which also lists 1 linked publication.
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 21 Feb 2019.