COMT on Aspirin Platelets Effects (CAPE)

Phase 4

• Conditions: Cardiovascular Diseases
• Interventions: Drug: Placebo; Drug: Aspirin 81 mg

• Registration Number: NCT03433586
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-02-09
• Study First Submitted QC: 2018-02-09
• Study First Posted: 2018-02-14
• Study Start: 2020-07-10
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-23
• Last Update Posted: 2021-06-25
• Primary Completion: 2022-01-30
• Study Completion: 2022-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• healthy, 18-40 years

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo pills that are visually identical to the Aspirin pills will be taken orally, daily for 10-14 days
Aspirin	Aspirin 81 mg	Aspirin (81mg) will be taken orally daily for 10-14 days.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
% 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

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States