Cardiovascular Diseases
Conditions
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.
Interventions
DRUGAspirin 81 mg
81mg of aspirin to be taken daily for 10-14 days
DRUGPlacebo
Placebo pill (visually identical to aspirin pill) to be taken daily for 10-14 days
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blind
Intervention model description
participants will be randomized to aspirin or placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy, 18-40 years
Exclusion criteria
* taking aspirin. Smoking, pregnancy, history of cancer of cardiovascular disease. Mental illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| % 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 |
Countries
United States
Contacts
Primary ContactKathryn T Hall, PhD
Backup ContactElaine Zaharris
Outcome results
None listed