COMT on Aspirin Platelets Effects (CAPE)

Cardiovascular Diseases Clinical Trial

— CAPE  

Official title:

COMT on Aspirin Platelets Effects (CAPE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03433586
• Other study ID #: 2015D006250
• Secondary ID: K01HL130625
• Status: Recruiting
• Phase: Phase 4
• Start date: July 10, 2020
• Est. completion date: April 30, 2022

Study information

• Verified date: June 2021
• Source: Brigham and Women's Hospital
• Contact: Kathryn T Hall, PhD
• Phone: 617 278 0938
• Email: khall0[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: April 30, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• healthy, 18-40 years

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 T — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	platelet aggregation	Platelets will be activated with arachidonic acid, thrombin, collagen, ADP and epinephrine	At end of treatment 10-14 days the platelets will be activated on the same day as blood collection.
Secondary	% expression of P-selectin on resting and activated platelets	Platelets activated with arachidonic acid, ADP, collagen and epinephrine	At end of treatment 10-14 days the platelets will be activated on the same day as blood collection.