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COMT on Aspirin Platelets Effects (CAPE) (CAPE)

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ClinicalTrials.gov Identifier: NCT03433586
Recruitment Status : Not yet recruiting
First Posted : February 14, 2018
Last Update Posted : March 15, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Kathryn Tayo Hall, Brigham and Women's Hospital

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
Cardiovascular Diseases Drug: Aspirin 81 mg Not Applicable

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 enroll 100 healthy participants with the intention of studying 90 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: participants 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)
Estimated Study Start Date : April 20, 2019
Estimated Primary Completion Date : January 30, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

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: Aspirin 81 mg
81mg of aspirin for 10+/-3 days
Other Name: acetylsalicylic acid

Active Comparator: Aspirin
Aspirin (81mg) will be taken orally daily for 10-14 days.
Drug: Aspirin 81 mg
81mg of aspirin for 10+/-3 days
Other Name: acetylsalicylic acid




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. % 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



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy, 18-40 years

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03433586


Contacts
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Contact: Kathryn T Hall, PhD 617 278 0938 khall0@bwh.harvard.edu
Contact: Elaine Zaharris 617 278 0472 ezaharris@rics.bwh.harvard.edu

Sponsors and Collaborators
Brigham and Women's Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Kathryn T Hall, PhD Brigham and Women's Hospital

Publications of Results:
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Responsible Party: Kathryn Tayo Hall, Assistant Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03433586     History of Changes
Other Study ID Numbers: 2015D006250
K01HL130625 ( U.S. NIH Grant/Contract )
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No current plan

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Aspirin
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics