COMT on Aspirin Platelets Effects (CAPE)

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: January 30, 2022

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.

Interventions

  • Drug: Aspirin 81 mg
    • 81mg of aspirin to be taken daily for 10-14 days
  • Drug: Placebo
    • Placebo pill (visually identical to aspirin pill) to be taken daily for 10-14 days

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • platelet aggregation
    • Time Frame: 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 Measures

  • % expression of P-selectin on resting and activated platelets
    • Time Frame: 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

Participating in This Clinical Trial

Inclusion Criteria

  • healthy, 18-40 years Exclusion Criteria:

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Brigham and Women’s Hospital
  • Collaborator
    • National Heart, Lung, and Blood Institute (NHLBI)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kathryn Tayo Hall, Assistant Professor – Brigham and Women’s Hospital
  • Overall Official(s)
    • Kathryn T Hall, PhD, Principal Investigator, Brigham and Women’s Hospital
  • Overall Contact(s)
    • Kathryn T Hall, PhD, 617 278 0938, khall0@bwh.harvard.edu

Citations Reporting on Results

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.

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