Clinical trial NCT03433586: COMT on Aspirin Platelets Effects (CAPE)
Official title: COMT on Aspirin Platelets Effects (CAPE)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cardiovascular Diseases
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-02-14
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: participants will be randomized to aspirin or placebo
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

* healthy, 18-40 years

Exclusion Criteria:

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

Primary outcomes:
measure: platelet aggregation
timeFrame: At end of treatment 10-14 days the platelets will be activated on the same day as blood collection.
Secondary outcomes:
measure: % expression of P-selectin on resting and activated platelets
timeFrame: At end of treatment 10-14 days the platelets will be activated on the same day as blood collection.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Kathryn T Hall, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.