COMT on Aspirin Platelets Effects (CAPE)

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

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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