COMT on Aspirin Platelets Effects (CAPE)

Study Overview
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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.

Official Title
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COMT on Aspirin Platelets Effects (CAPE)

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Drug: Aspirin 81 mg
* Drug: Placebo


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: participants will be randomized to aspirin or placebo
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo pills that are visually identical to the Aspirin pills will be taken orally, daily for 10-14 days | Drug: Placebo<br>* Placebo pill (visually identical to aspirin pill) to be taken daily for 10-14 days<br>|
| Active Comparator: Aspirin<br>Aspirin (81mg) will be taken orally daily for 10-14 days. | Drug: Aspirin 81 mg<br>* 81mg of aspirin to be taken daily for 10-14 days<br>* Other names: acetylsalicylic acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % 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. |