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COMT on Aspirin Platelets Effects (CAPE)

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03433586
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
45
Enrollment
1
Location
2
Arms
21.7
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Aspirin 81 mg
  • Drug: Placebo
 Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
participants will be randomized to aspirin or placeboparticipants will be randomized to aspirin or placebo
Masking:
Double (Participant, Investigator)
Masking Description:
Double-blind
Primary Purpose:
Basic Science
Official Title:
COMT on Aspirin Platelets Effects (CAPE)
Actual Study Start Date :
Jul 10, 2020
Anticipated Primary Completion Date :
Jan 30, 2022
Anticipated Study Completion Date :
Apr 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

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

Drug: Placebo
Placebo pill (visually identical to aspirin pill) to be taken daily for 10-14 days
Active Comparator: Aspirin

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
Other Names:
  • acetylsalicylic acid

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. % 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 Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • healthy, 18-40 years
    Exclusion Criteria:
    • taking aspirin. Smoking, pregnancy, history of cancer of cardiovascular disease. Mental illness.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Brigham and Women's Hospital Boston Massachusetts United States 02115

    Sponsors and Collaborators

    • Brigham and Women's Hospital
    • National Heart, Lung, and Blood Institute (NHLBI)

    Investigators

    • Principal Investigator: Kathryn T Hall, PhD, Brigham and Women's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kathryn Tayo Hall, Assistant Professor, Brigham and Women's Hospital
    ClinicalTrials.gov Identifier:
    NCT03433586
    Other Study ID Numbers:
    • 2015D006250
    • K01HL130625
    First Posted:
    Feb 14, 2018
    Last Update Posted:
    Jun 25, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Cardiovascular Diseases
    Aspirin

    Study Results

    No Results Posted as of Jun 25, 2021