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Lack of funds for specimen management and data analysis
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The investigators are attempting to determine if the response to aspirin in women is related to the level of estrogen and progesterone that a woman has.
Thrombosis plays a significant role in both acute coronary syndromes (ACS) and early saphenous vein graft (SVG) failure. Women with coronary heart disease have higher levels of the inflammatory mediator thromboxane, which is produced by platelets, monocytes, macrophages and the endothelium. Data show that higher levels of urinary thromboxane (UTXB2) are associated with SVG failure 6 months after Coronary Artery Bypass Graft (CABG). Women in the study cohort had higher levels of UTXB2 and higher odds of graft failure when compared to men. The elevated urinary thromboxane seen in the women in our study cohort may represent a marker and/or an etiology of thrombosis.
Are the levels of UTXB2 higher in women due to hormonal differences? In a prior pilot study we investigated whether hormonal levels are associated with changes in urinary thromboxane. We looked at hormonal and urinary thromboxane levels in 48 postmenopausal and 52 premenopausal women. We found that postmenopausal women had higher levels of UTXB2 than did premenopausal women (2495 vs. 2299, p=.02) and that in premenopausal women a higher estrogen/progesterone ratio was associated with the highest levels of urinary thromboxane.
The goal of the current study is to measure the response to seven days of aspirin administration as it relates to urinary thromboxane levels in pre and post-menopausal women. With this study we will be able to examine the change in UTXB2 comparing the premenopausal to post menopausal women. We will also be able to see if the change in UTXB2 in response to aspirin is affected by hormone levels in the premenopausal women. Lastly this study will provide reference data for more far-reaching studies exploring how global changes in hormonal balance (as seen in pregnancy or menopause) or in the level of inflammation (as seen in aging or with Coronary Artery Disease (CAD) risk factors), affect UTXB2 and platelet hyperreactivity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirin | Experimental | The patients are given aspirin 81 mg orally for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin 81 mg | Drug | Aspirin 81 mg orally daily for 7 days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Level of Urinary Thromboxane (UTXB2) in pg/mg Creatinine | Urinary thromboxane (pg/mg creatinine) will be measured in premenopausal and postmenopausal women at baseline and then after taking on aspirin for 7 days. | Baseline |
| The Change in the Level of UTXB2 in pg/mg Creatinine: Estrogen and Progesterone | Measurement of urinary thromboxane (pg/mg creatinine) in relation to estrogen to progesterone level in premenopausal women on aspirin for 7 days. | baseline to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Level of UTXB2 in pg/mg Creatinine | Comparing premenopausal women to postmenopausal women, the level of urinary thromboxane (pg/mg creatinine) in response to aspirin | baseline |
| Relative Change of UTXB2 in pg/mg Creatinine in Response to Aspirin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rhondalyn McLean, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Premenopausal | Aspirin 81 mg PO daily x 7 days |
| FG001 | Postmenopausal | Aspirin 81 mg PO daily x 7 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Premenopausal | Aspirin 81 mg PO daily x 7 days |
| BG001 | Postmenopausal | Aspirin 81 mg PO daily x 7 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Level of Urinary Thromboxane (UTXB2) in pg/mg Creatinine | Urinary thromboxane (pg/mg creatinine) will be measured in premenopausal and postmenopausal women at baseline and then after taking on aspirin for 7 days. | Data was only collected at baseline. The study was terminated prior to initiation of intervention (Aspirin) and therefore no follow-up data was collected to calculate the change from baseline. | Posted | Median | Inter-Quartile Range | pg/mg | Baseline |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Premenopausal | Aspirin 81 mg PO daily x 7 days | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| RhondaLyn McLean | Johns Hopkins University School of Medicine | (215) 662-4949 | rhondalyn.mclean@uphs.upenn.edu |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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Comparing premenopausal women to postmenopausal women, the level of urinary thromboxane (pg/mg creatinine) in response to aspirin
| change from baseline to 7 days |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | The Change in the Level of UTXB2 in pg/mg Creatinine: Estrogen and Progesterone | Measurement of urinary thromboxane (pg/mg creatinine) in relation to estrogen to progesterone level in premenopausal women on aspirin for 7 days. | Data was only collected at baseline. The study was terminated prior to obtaining study data. | Posted | baseline to 7 days |
|
|
|
| Secondary | Level of UTXB2 in pg/mg Creatinine | Comparing premenopausal women to postmenopausal women, the level of urinary thromboxane (pg/mg creatinine) in response to aspirin | Data was only collected at baseline. The study was terminated prior to initiation of intervention (Aspirin) and therefore no follow-up data was collected to calculate the change from baseline. | Posted | Median | Inter-Quartile Range | pg/mg | baseline |
|
|
|
| Secondary | Relative Change of UTXB2 in pg/mg Creatinine in Response to Aspirin | Comparing premenopausal women to postmenopausal women, the level of urinary thromboxane (pg/mg creatinine) in response to aspirin | No data was collected for this outcome measure, as the study was terminated prematurely | Posted | change from baseline to 7 days |
|
|
| 52 |
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | Postmenopausal | Aspirin 81 mg PO daily x 7 days | 0 | 48 | 0 | 48 | 0 | 48 |
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| D016769 |
| Embolism and Thrombosis |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |