Hormones Inflammation and Thrombosis (HIT2)
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|ClinicalTrials.gov Identifier: NCT01875185|
Recruitment Status : Terminated (Lack of funds for specimen management and data analysis)
First Posted : June 11, 2013
Results First Posted : May 7, 2018
Last Update Posted : May 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Coronary Syndrome Thrombosis||Drug: Aspirin 81 mg||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hormones Inflammation and Thrombosis|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
The patients are given aspirin 81 mg orally for 7 days.
Drug: Aspirin 81 mg
Aspirin 81 mg orally daily for 7 days
Other Name: ASP
- Level of Urinary Thromboxane (UTXB2) in pg/mg Creatinine [ Time Frame: Baseline ]Urinary thromboxane (pg/mg creatinine) will be measured in premenopausal and postmenopausal women at baseline and then after taking on aspirin for 7 days.
- The Change in the Level of UTXB2 in pg/mg Creatinine: Estrogen and Progesterone [ Time Frame: baseline to 7 days ]Measurement of urinary thromboxane (pg/mg creatinine) in relation to estrogen to progesterone level in premenopausal women on aspirin for 7 days.
- Level of UTXB2 in pg/mg Creatinine [ Time Frame: baseline ]Comparing premenopausal women to postmenopausal women, the level of urinary thromboxane (pg/mg creatinine) in response to aspirin
- Relative Change of UTXB2 in pg/mg Creatinine in Response to Aspirin [ Time Frame: change from baseline to 7 days ]Comparing premenopausal women to postmenopausal women, the level of urinary thromboxane (pg/mg creatinine) in response to aspirin
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): NCT01875185
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Rhondalyn McLean, MD||Johns Hopkins University|