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| ID | Type | Description | Link |
|---|---|---|---|
| K01HL130625 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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 Aspirinâ„¢.
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 Aspirinâ„¢ (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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo pills that are visually identical to the Aspirin pills will be taken orally, daily for 10-14 days |
|
| Aspirin | Active Comparator | Aspirin (81mg) will be taken orally daily for 10-14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin 81 mg | Drug | 81mg of aspirin to be taken daily for 10-14 days |
|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kathryn T Hall, PhD | Contact | 617 278 0938 | khall0@bwh.harvard.edu | |
| Elaine Zaharris | Contact | 617 278 0472 | ezaharris@rics.bwh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kathryn T Hall, PhD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25035343 | Result | 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. |
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The generation of large-scale human or non-human genome data is not an explicit plan in this proposal. However, any genomic data as it pertains to single nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, epigenomic, or gene expression data produced from the work in this award will be made publicly available through the appropriate NIH data repositories including array express, Database of Genotypes and Phenotypes (dbGaP), Database of Short Genetic Variations (dbSNP) or Gene Expression Omnibus (GEO). We intend to share the results from this study in published manuscripts and presentations at National Meetings. Unique methodology or results developed or generated through this study will be made readily available for research purposes to qualified individuals within the scientific community. Interested researchers will be able to contact the corresponding authors of the publications for information about access to resources.
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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participants will be randomized to aspirin or placebo
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Double-blind
| Placebo | Drug | Placebo pill (visually identical to aspirin pill) to be taken daily for 10-14 days |
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| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |