COMT on Aspirin Platelets Effects (CAPE)

NCT ID: NCT03433586

Last Updated: 2021-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-10

Study Completion Date

2022-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

participants will be randomized to aspirin or placebo
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
Double-blind

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Aspirin

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

Group Type ACTIVE_COMPARATOR

Aspirin 81 mg

Intervention Type DRUG

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

Interventions

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Aspirin 81 mg

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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acetylsalicylic acid

Eligibility Criteria

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Inclusion Criteria

* healthy, 18-40 years

Exclusion Criteria

* taking aspirin. Smoking, pregnancy, history of cancer of cardiovascular disease. Mental illness.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kathryn Tayo Hall

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kathryn T Hall, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kathryn T Hall, PhD

Role: CONTACT

617 278 0938

Elaine Zaharris

Role: CONTACT

617 278 0472

Facility Contacts

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Kathryn Hall, PhD

Role: primary

617-278-0938

Harvey Roweth, PhD

Role: backup

References

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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.

Reference Type RESULT
PMID: 25035343 (View on PubMed)

Other Identifiers

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K01HL130625

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2015D006250

Identifier Type: -

Identifier Source: org_study_id

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