Hormones Inflammation and Thrombosis

Acute Coronary Syndrome Clinical Trial

— HIT2  

Official title:

Hormones Inflammation and Thrombosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01875185
• Other study ID #: NA_00079522
• Status: Terminated
• Phase: Phase 4
• Start date: December 2012
• Est. completion date: November 2013

Study information

• Verified date: April 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Women age 18-80

2. Signed informed consent.

Exclusion Criteria:

1. History of CAD, Cerebrovascular Accident (CVA) or Peripheral Artery Disease (PAD),

2. On chronic aspirin therapy,

3. On chronic NSAID therapy.

4. Chronic anticoagulation with coumadin,

5. Known thrombocytopenia (Platelet count < 100,000),

6. Pregnancy (self-report),

7. Currently on any type of contraceptive or hormone replacement therapy,

8. Hysterectomy and/or oophorectomy.

9. Recent GI bleeding

10. Bleeding diathesis

11. Chronic Systemic Infection

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Inflammation
• Thrombosis

Intervention

Drug:
• Aspirin 81 mg
Aspirin 81 mg orally daily for 7 days

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline
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.	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	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	change from baseline to 7 days