NCT03433586

COMT on Aspirin Platelets Effects (CAPE)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-07-10
• Primary completion: 2022-01-30
• Completion: 2022-04-30
• First posted: 2018-02-14
• Last updated: 2021-06-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study