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This is a descriptive study designed to evaluate the safety and feasibility of a precision medicine approach to antiplatelet selection for secondary stroke prevention.
Subjects meeting inclusion/exclusion criteria will be randomly assigned to: (1) the treatment group where antiplatelet medications will be selected using platelet function phenotype and/or key pharmacogene genotypes (2) the control group where participants will receive standard care for antiplatelet therapy (without knowledge of phenotype or genotype).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Intervention group |
|
| Control Group | Active Comparator | Standard of Care group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tailored antiplatelet selection | Drug | antiplatelet selection guided by platelet function phenotype and/or key pharmacogene genotypes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility - Recruitment and Platelet Reactivity | ability to recruit participants and achieve platelet reactivity target using platelet function assays | 90 days |
| Safety - Bleeding Complications | bleeding questionnaire | 90 days |
| Safety - Bleeding Complications | bleeding questionnaire | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-centered Outcomes - Satisfaction | consumer assessment of healthcare providers and systems | 90 days |
| Patient-centered Outcomes - Satisfaction | consumer assessment of healthcare providers and systems |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen C Albright, PhD, DO | State University of New York - Upstate Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SUNY Upstate Medical University | Syracuse | New York | 13202 | United States |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| standard of care | Drug | antiplatelet selection using standard of care |
|
| 1 year |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |