Hormones Inflammation and Thrombosis

NCT ID: NCT01875185

Last Updated: 2018-05-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2013-11-30

Brief 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.

Detailed 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.

Conditions

Acute Coronary Syndrome; Thrombosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Aspirin

The patients are given aspirin 81 mg orally for 7 days.

Group Type: EXPERIMENTAL

Aspirin 81 mg

Intervention Type: DRUG

Aspirin 81 mg orally daily for 7 days

Interventions

Aspirin 81 mg

Aspirin 81 mg orally daily for 7 days

Intervention Type: DRUG

Other Intervention Names

ASP

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rhondalyn McLean, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00079522

Identifier Type: -

Identifier Source: org_study_id