A Phase 4 interventional study of Aspirin 81 mg and Placebo in Cardiovascular Diseases, sponsored by Brigham and Women's Hospital. Status unknown at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-25.
Sponsored by Brigham and Women's Hospital · Phase 4, Interventional, and Basic science
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.
This is a randomized double-blinded, placebo controlled study. This study is designed to detect the variation in platelet function based on COMT variation and how these platelets respond to cancerous cells.
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.
5,368 studies on the registry are indexed under Cardiovascular Diseases; 939 are open to participants now.
This study's planned enrollment of 45 is below the median of 100 across 3,084 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Placebo pills that are visually identical to the Aspirin pills will be taken orally, daily for 10-14 days
Drug: Placebo
Aspirin (81mg) will be taken orally daily for 10-14 days.
Drug: Aspirin 81 mg
81mg of aspirin to be taken daily for 10-14 days
Also known as: acetylsalicylic acid
Placebo pill (visually identical to aspirin pill) to be taken daily for 10-14 days
platelet aggregation
Platelets will be activated with arachidonic acid, thrombin, collagen, ADP and epinephrine
Time frame: At end of treatment 10-14 days the platelets will be activated on the same day as blood collection.
% expression of P-selectin on resting and activated platelets
Platelets activated with arachidonic acid, ADP, collagen and epinephrine
Time frame: At end of treatment 10-14 days the platelets will be activated on the same day as blood collection.
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Started Jul 2020 (actual). Primary completion is estimated for Jan 2022, 18 months after the start.
Of 107 non-industry phase 4 interventional studies under Cardiovascular Diseases, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 76. This study's planned 18 months is below that.
Counting every sponsor, half of 113 studies reached it within 46 months; a quarter within 26 and three quarters within 64.
Cardiovascular Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Aspirin
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