COMT on Aspirin Platelets Effects (CAPE)
CAPE
2 other identifiers
interventional
45
1 country
1
Brief Summary
Specific Aim I: Examine the role of genetic variation in COMT on platelet function in a blinded, randomized, placebo controlled clinical trial of daily placebo or Aspirin (81mg) for 10 ± 3 days. Platelet function will be assessed with platelet aggregometry and by fluorescence-activated cell sorting (FACS) of platelet adhesion molecules P-selectin and GPIIb/IIIa in platelets activated with arachidonic acid, thrombin, collagen, epinephrine and ADP. Specific Aim II: Examine the effects of platelet releasates harvested at the end of each treatment arm on angiogenesis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 cardiovascular-diseases
Started Jul 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2018
CompletedFirst Posted
Study publicly available on registry
February 14, 2018
CompletedStudy Start
First participant enrolled
July 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2022
CompletedJune 25, 2021
June 1, 2021
1.6 years
February 9, 2018
June 23, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
platelet aggregation
Platelets will be activated with arachidonic acid, thrombin, collagen, ADP and epinephrine
At end of treatment 10-14 days the platelets will be activated on the same day as blood collection.
Secondary Outcomes (1)
% expression of P-selectin on resting and activated platelets
At end of treatment 10-14 days the platelets will be activated on the same day as blood collection.
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo pills that are visually identical to the Aspirin pills will be taken orally, daily for 10-14 days
Aspirin
ACTIVE COMPARATORAspirin (81mg) will be taken orally daily for 10-14 days.
Interventions
81mg of aspirin to be taken daily for 10-14 days
Placebo pill (visually identical to aspirin pill) to be taken daily for 10-14 days
Eligibility Criteria
You may qualify if:
- healthy, 18-40 years
You may not qualify if:
- taking aspirin. Smoking, pregnancy, history of cancer of cardiovascular disease. Mental illness.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Related Publications (1)
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.
PMID: 25035343RESULT
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathryn T Hall, PhD
Brigham and Women's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double-blind
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 9, 2018
First Posted
February 14, 2018
Study Start
July 10, 2020
Primary Completion
January 30, 2022
Study Completion
April 30, 2022
Last Updated
June 25, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
The generation of large-scale human or non-human genome data is not an explicit plan in this proposal. However, any genomic data as it pertains to single nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, epigenomic, or gene expression data produced from the work in this award will be made publicly available through the appropriate NIH data repositories including array express, Database of Genotypes and Phenotypes (dbGaP), Database of Short Genetic Variations (dbSNP) or Gene Expression Omnibus (GEO). We intend to share the results from this study in published manuscripts and presentations at National Meetings. Unique methodology or results developed or generated through this study will be made readily available for research purposes to qualified individuals within the scientific community. Interested researchers will be able to contact the corresponding authors of the publications for information about access to resources.