Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
45 participants
INTERVENTIONAL
2020-07-10
2022-04-30
Brief Summary
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Specific Aim II: Examine the effects of platelet releasates harvested at the end of each treatment arm on angiogenesis.
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Detailed Description
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We expect to recruit 60 healthy participants with the intention of studying 45 participants to complete the protocol.
Individuals aged 18 to 40 years will be eligible to participate in this study if they do not have history of fainting/problems related to blood draws, major chronic medical illnesses, regular or current treatment of Aspirin™.
Examine the role of genetic variation in in catechol-O-methyltransferase (COMT) on platelet function in a randomized double-blinded placebo controlled clinical trial of daily Aspirin™ (81 mg) versus placebo over 10-14 days. Platelet function will be assessed with a platelet aggregometry and by fluorescence-activated cell sorting assessment of platelet adhesion molecule GPIIIb/IIIa and p-selectin.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Placebo
Placebo pills that are visually identical to the Aspirin pills will be taken orally, daily for 10-14 days
Placebo
Placebo pill (visually identical to aspirin pill) to be taken daily for 10-14 days
Aspirin
Aspirin (81mg) will be taken orally daily for 10-14 days.
Aspirin 81 mg
81mg of aspirin to be taken daily for 10-14 days
Interventions
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Aspirin 81 mg
81mg of aspirin to be taken daily for 10-14 days
Placebo
Placebo pill (visually identical to aspirin pill) to be taken daily for 10-14 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
40 Years
ALL
Yes
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Brigham and Women's Hospital
OTHER
Responsible Party
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Kathryn Tayo Hall
Assistant Professor
Principal Investigators
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Kathryn T Hall, PhD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Hall KT, Nelson CP, Davis RB, Buring JE, Kirsch I, Mittleman MA, Loscalzo J, Samani NJ, Ridker PM, Kaptchuk TJ, Chasman DI. Polymorphisms in catechol-O-methyltransferase modify treatment effects of aspirin on risk of cardiovascular disease. Arterioscler Thromb Vasc Biol. 2014 Sep;34(9):2160-7. doi: 10.1161/ATVBAHA.114.303845. Epub 2014 Jul 17.
Other Identifiers
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2015D006250
Identifier Type: -
Identifier Source: org_study_id
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