COMT on Aspirin Platelets Effects (CAPE)

NCT03433586 — Phase 4, Unknown, 45 participants, Brigham and Women's Hospital

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Registry	NCT03433586, acronym CAPE
Status	Unknown
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: double, basic science
Enrollment	45 (Estimated)
Sponsor	Brigham and Women's Hospital (Other); collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions	Cardiovascular Diseases
Interventions	Aspirin 81 mg, Placebo (Drug)
Dates	start 2020-07-10, primary completion 2022-01-30 (estimated), completion 2022-04-30 (estimated), first posted 2018-02-14, last updated 2021-06-25
Locations	1 site in United States

-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.

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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
Placebo	Placebo comparator	Drug: Placebo	Placebo pills that are visually identical to the Aspirin pills will be taken orally, daily for 10-14 days
Aspirin	Active comparator	Drug: Aspirin 81 mg	Aspirin (81mg) will be taken orally daily for 10-14 days.

Aspirin 81 mg (Drug), also known as acetylsalicylic acid: 81mg of aspirin to be taken daily for 10-14 days
Placebo (Drug): Placebo pill (visually identical to aspirin pill) to be taken daily for 10-14 days

+Outcome measures

Primary outcomes

platelet aggregation [At end of treatment 10-14 days the platelets will be activated on the same day as blood collection.]: Platelets will be activated with arachidonic acid, thrombin, collagen, ADP and epinephrine

Secondary outcomes

% 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.]: Platelets activated with arachidonic acid, ADP, collagen and epinephrine

+Eligibility

Sex: All, ages: 18 Years to 40 Years, accepts healthy volunteers

Inclusion Criteria:

* healthy, 18-40 years

Exclusion Criteria:

* taking aspirin. Smoking, pregnancy, history of cancer of cardiovascular disease. Mental illness.

+Locations (1)

Facility	City	Country	Status
Brigham and Women's Hospital	Boston, Massachusetts	United States	Recruiting

+Publications

Results publication: 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 25035343

+Investigators

Kathryn T Hall, PhD, Principal investigator, Brigham and Women's Hospital

+Funding

NIH grants: K01HL130625

My Notes

Public

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