COMT on Aspirin Platelets Effects (CAPE) (CAPE)
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| ClinicalTrials.gov Identifier: NCT03433586 |
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Recruitment Status :
Recruiting
First Posted : February 14, 2018
Last Update Posted : June 25, 2021
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cardiovascular Diseases | Drug: Aspirin 81 mg Drug: Placebo | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 45 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | participants will be randomized to aspirin or placebo |
| Masking: | Double (Participant, Investigator) |
| Masking Description: | Double-blind |
| Primary Purpose: | Basic Science |
| Official Title: | COMT on Aspirin Platelets Effects (CAPE) |
| Actual Study Start Date : | July 10, 2020 |
| Estimated Primary Completion Date : | January 30, 2022 |
| Estimated Study Completion Date : | April 30, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
Placebo pills that are visually identical to the Aspirin pills will be taken orally, daily for 10-14 days
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Drug: Placebo
Placebo pill (visually identical to aspirin pill) to be taken daily for 10-14 days |
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Active Comparator: Aspirin
Aspirin (81mg) will be taken orally daily for 10-14 days.
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Drug: Aspirin 81 mg
81mg of aspirin to be taken daily for 10-14 days
Other Name: acetylsalicylic acid |
- platelet aggregation [ Time Frame: 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
- % expression of P-selectin on resting and activated platelets [ Time Frame: 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- healthy, 18-40 years
Exclusion Criteria:
- taking aspirin. Smoking, pregnancy, history of cancer of cardiovascular disease. Mental illness.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03433586
| Contact: Kathryn T Hall, PhD | 617 278 0938 | khall0@bwh.harvard.edu | |
| Contact: Elaine Zaharris | 617 278 0472 | ezaharris@rics.bwh.harvard.edu |
| United States, Massachusetts | |
| Brigham and Women's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Kathryn Hall, PhD 617-278-0938 khall0@bwh.harvard.edu | |
| Contact: Harvey Roweth, PhD hroweth@bwh.harvard.edu | |
| Principal Investigator: | Kathryn T Hall, PhD | Brigham and Women's Hospital |
| Responsible Party: | Kathryn Tayo Hall, Assistant Professor, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT03433586 |
| Other Study ID Numbers: |
2015D006250 K01HL130625 ( U.S. NIH Grant/Contract ) |
| First Posted: | February 14, 2018 Key Record Dates |
| Last Update Posted: | June 25, 2021 |
| Last Verified: | June 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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