Hormones Inflammation & Thrombosis

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01875185
Study type	Interventional
Source	Johns Hopkins University
Contact
Status	Terminated
Phase	Phase 4
Start date	December 2012
Completion date	November 2013

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Hormones Inflammation and Thrombosis — HIT2

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms