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Trial record 10 of 85 for:    ASPIRIN AND thromboxane

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
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Thrombosis Drug: Aspirin 81 mg Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Hormones Inflammation and Thrombosis
Study Start Date : December 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: Aspirin
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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
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United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Rhondalyn McLean, MD Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01875185     History of Changes
Other Study ID Numbers: NA_00079522
First Posted: June 11, 2013    Key Record Dates
Results First Posted: May 7, 2018
Last Update Posted: May 7, 2018
Last Verified: April 2018

Keywords provided by Johns Hopkins University:
acute coronary syndrome
clotting
hormones
women

Additional relevant MeSH terms:
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Aspirin
Inflammation
Thrombosis
Acute Coronary Syndrome
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Myocardial Ischemia
Heart Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics