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COMT on Aspirin Platelets Effects (CAPE)

Mass General Brigham logo

Mass General Brigham

Status and phase

Unknown
Phase 4

Conditions

Cardiovascular Diseases

Treatments

Drug: Aspirin 81 mg
Drug: Placebo

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03433586
2015D006250
K01HL130625 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • healthy, 18-40 years

Exclusion criteria

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

45 participants in 2 patient groups, including a placebo group

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

Trial contacts and locations

1

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Central trial contact

Elaine Zaharris; Kathryn T Hall, PhD

Data sourced from clinicaltrials.gov

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