Condition or disease | Intervention/treatment | Phase |
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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 |
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Experimental: Treatment Group
Intervention group
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Drug: tailored antiplatelet selection
antiplatelet selection guided by platelet function phenotype and/or key pharmacogene genotypes
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Active Comparator: Control Group
Standard of Care group
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Drug: standard of care
antiplatelet selection using standard of care
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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 | |||||||||
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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 | ||||||||
* 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 |