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Hormones Inflammation and Thrombosis (HIT2)

Primary Purpose

Acute Coronary Syndrome, Thrombosis

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Aspirin 81 mg
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Coronary Syndrome focused on measuring acute coronary syndrome, clotting, hormones, women

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aspirin

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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
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

Full Information

First Posted
June 7, 2013
Last Updated
April 2, 2018
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT01875185
Brief Title
Hormones Inflammation and Thrombosis
Acronym
HIT2
Official Title
Hormones Inflammation and Thrombosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
Lack of funds for specimen management and data analysis
Study Start Date
December 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Thrombosis
Keywords
acute coronary syndrome, clotting, hormones, women

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aspirin
Arm Type
Experimental
Arm Description
The patients are given aspirin 81 mg orally for 7 days.
Intervention Type
Drug
Intervention Name(s)
Aspirin 81 mg
Other Intervention Name(s)
ASP
Intervention Description
Aspirin 81 mg orally daily for 7 days
Primary Outcome Measure Information:
Title
Level of Urinary Thromboxane (UTXB2) in pg/mg Creatinine
Description
Urinary thromboxane (pg/mg creatinine) will be measured in premenopausal and postmenopausal women at baseline and then after taking on aspirin for 7 days.
Time Frame
Baseline
Title
The Change in the Level of UTXB2 in pg/mg Creatinine: Estrogen and Progesterone
Description
Measurement of urinary thromboxane (pg/mg creatinine) in relation to estrogen to progesterone level in premenopausal women on aspirin for 7 days.
Time Frame
baseline to 7 days
Secondary Outcome Measure Information:
Title
Level of UTXB2 in pg/mg Creatinine
Description
Comparing premenopausal women to postmenopausal women, the level of urinary thromboxane (pg/mg creatinine) in response to aspirin
Time Frame
baseline
Title
Relative Change of UTXB2 in pg/mg Creatinine in Response to Aspirin
Description
Comparing premenopausal women to postmenopausal women, the level of urinary thromboxane (pg/mg creatinine) in response to aspirin
Time Frame
change from baseline to 7 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women age 18-80 Signed informed consent. Exclusion Criteria: History of CAD, Cerebrovascular Accident (CVA) or Peripheral Artery Disease (PAD), On chronic aspirin therapy, On chronic NSAID therapy. Chronic anticoagulation with coumadin, Known thrombocytopenia (Platelet count < 100,000), Pregnancy (self-report), Currently on any type of contraceptive or hormone replacement therapy, Hysterectomy and/or oophorectomy. Recent GI bleeding Bleeding diathesis Chronic Systemic Infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rhondalyn McLean, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

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Hormones Inflammation and Thrombosis

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