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Study to evaluate the performance of the AggreGuide A-100 ADP assay for detection of platelet dysfunction caused by P2Y12 inhibitor antiplatelet therapy.
Study subjects will have A-100 ADP measurements performed at baseline and after initiation of P2Y12 inhibitor antiplatelet therapy, following loading and maintenance doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P2Y12 inhibitor | Drug | Administration of P2Y12 inhibitor antiplatelet therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Platelet Activity Index (PAI) | Platelet reactivity measurement using A-100 ADP assay | Baseline, day 1, day 7 |
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Inclusion Criteria:
Subject has a history of cardiovascular disease OR
Subject has 2 or more cardiac risk factors:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Phil Speros | Aggredyne, Inc. | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34143384 | Derived | 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. |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| D000068799 | Prasugrel Hydrochloride |
| D000077486 | Ticagrelor |
| D010979 | Platelet Function Tests |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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Platelet function test results are not provided to the participant, care provider, or investigator
| Platelet function test | Device | Blood is drawn for testing of platelet aggregation activity |
|
|
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010879 | Piperazines |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D006403 | Hematologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |