Recruiting

CAPE

Sponsor:

Brigham and Women's Hospital

Code:

NCT03433586

Conditions

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Aspirin 81 mg

Placebo

Study Details

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.

Conditions

Cardiovascular Diseases

Study ID

NCT03433586

Start date

Jul 10, 2020

Status verified date

Jun, 2021

Completion date

Apr 30, 2022

Anticipated

Primary completion date

Jan 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Inclusion Criteria:

  • healthy, 18-40 years

Exclusion Criteria:

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

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Placebo pills that are visually identical to the Aspirin pills will be taken orally, daily for 10-14 days

active comparator: Aspirin

Aspirin (81mg) will be taken orally daily for 10-14 days.

Interventions

Aspirin 81 mg

81mg of aspirin to be taken daily for 10-14 days

Placebo

Placebo pill (visually identical to aspirin pill) to be taken daily for 10-14 days

Primary outcome measure

  • platelet aggregation [ Time Frame: At end of treatment 10-14 days the platelets will be activated on the same day as blood collection. ]

Central Contacts and Locations

Central contacts

Kathryn T Hall, PhD

617 278 0938khall0@bwh.harvard.edu

Elaine Zaharris

617 278 0472ezaharris@rics.bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Kathryn Hall, PhD

617-278-0938khall0@bwh.harvard.edu

Harvey Roweth, PhD

hroweth@bwh.harvard.edu

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Jun 25, 2021

Last verified

Jun, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2021-06-25.