| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ischemic Stroke TIA | Drug: tailored antiplatelet selection Drug: standard of care | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Personalized Antiplatelet Secondary Stroke PRevenTion (PASSPoRT). A Randomized, Phase II, Open Label, Trial in High Risk Transient Ischemic Attack (TIA) and Ischemic Stroke Survivors Age 18 Years and Older |
| Actual Study Start Date : | June 11, 2018 |
| Estimated Primary Completion Date : | July 1, 2021 |
| Estimated Study Completion Date : | July 1, 2021 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Treatment Group
Intervention group
|
Drug: tailored antiplatelet selection
antiplatelet selection guided by platelet function phenotype and/or key pharmacogene genotypes
|
|
Active Comparator: Control Group
Standard of Care group
|
Drug: standard of care
antiplatelet selection using standard of care
|
| Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Karen C Albright, PhD, DO | 315-464-4689 | AlbrighK@upstate.edu | |
| Contact: Michelle Klick, LPN, CCRP | 315-464-5729 | KlickM@upstate.edu |
| United States, New York | |
| SUNY Upstate Medical University | Recruiting |
| Syracuse, New York, United States, 13202 | |
| Contact: Karen C Albright, PhD, DO 315-464-6489 AlbrighK@upstate.edu | |
| Contact: Michelle Klick, LPN, CCRP 3154645729 KlickM@upstate.edu | |
| Principal Investigator: | Karen C Albright, PhD, DO | State University of New York - Upstate Medical University |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | March 18, 2019 | ||||||||
| First Posted Date ICMJE | June 7, 2019 | ||||||||
| Last Update Posted Date | October 29, 2020 | ||||||||
| Actual Study Start Date ICMJE | June 11, 2018 | ||||||||
| Estimated Primary Completion Date | July 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Personalized Antiplatelet Secondary Stroke PRevenTion | ||||||||
| Official Title ICMJE | Personalized Antiplatelet Secondary Stroke PRevenTion (PASSPoRT). A Randomized, Phase II, Open Label, Trial in High Risk Transient Ischemic Attack (TIA) and Ischemic Stroke Survivors Age 18 Years and Older | ||||||||
| Brief Summary | This is a descriptive study designed to evaluate the safety and feasibility of a precision medicine approach to antiplatelet selection for secondary stroke prevention. | ||||||||
| Detailed Description | 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). | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
60 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | July 1, 2021 | ||||||||
| Estimated Primary Completion Date | July 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 100 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03979781 | ||||||||
| Other Study ID Numbers ICMJE | 1158092 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | State University of New York - Upstate Medical University | ||||||||
| Study Sponsor ICMJE | State University of New York - Upstate Medical University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | State University of New York - Upstate Medical University | ||||||||
| Verification Date | October 2020 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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