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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Acute Coronary Syndrome
Thrombosis
Intervention Drug: Aspirin 81 mg
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Premenopausal Postmenopausal
Hide Arm/Group Description Aspirin 81 mg PO daily x 7 days Aspirin 81 mg PO daily x 7 days
Period Title: Overall Study
Started 52 48
Completed 0 0
Not Completed 52 48
Reason Not Completed
study was terminated             52             48
Arm/Group Title Premenopausal Postmenopausal Total
Hide Arm/Group Description Aspirin 81 mg PO daily x 7 days Aspirin 81 mg PO daily x 7 days Total of all reporting groups
Overall Number of Baseline Participants 52 48 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 48 participants 100 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
52
 100.0%
0
   0.0%
52
  52.0%
>=65 years
0
   0.0%
48
 100.0%
48
  48.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 48 participants 100 participants
Female
52
 100.0%
48
 100.0%
100
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 52 participants 48 participants 100 participants
52
 100.0%
48
 100.0%
100
 100.0%
1.Primary Outcome
Title Level of Urinary Thromboxane (UTXB2) in pg/mg Creatinine
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Data was only collected at baseline. The study was terminated prior to initiation of intervention (Aspirin) and therefore no follow-up data was collected to calculate the change from baseline.
Arm/Group Title Premenopausal Postmenopausal
Hide Arm/Group Description:
premenopausal Women in the cohort
Postmenopausal Women in the cohort
Overall Number of Participants Analyzed 52 48
Median (Inter-Quartile Range)
Unit of Measure: pg/mg
2495
(1775 to 3053)
2299
(1724 to 2687)
2.Primary Outcome
Title The Change in the Level of UTXB2 in pg/mg Creatinine: Estrogen and Progesterone
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Data was only collected at baseline. The study was terminated prior to obtaining study data.
Arm/Group Title Premenopausal Postmenopausal
Hide Arm/Group Description:
Aspirin 81 mg PO daily x 7 days
Aspirin 81 mg PO daily x 7 days
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Level of UTXB2 in pg/mg Creatinine
Hide Description Comparing premenopausal women to postmenopausal women, the level of urinary thromboxane (pg/mg creatinine) in response to aspirin
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Data was only collected at baseline. The study was terminated prior to initiation of intervention (Aspirin) and therefore no follow-up data was collected to calculate the change from baseline.
Arm/Group Title Premenopausal Postmenopausal
Hide Arm/Group Description:
Premenopausal females in the cohort Aspirin 81 mg PO daily x 7 days
Postmenopausal females in the cohort Aspirin 81 mg PO daily x 7 days
Overall Number of Participants Analyzed 52 48
Median (Inter-Quartile Range)
Unit of Measure: pg/mg
2299
(1724 to 2687)
2824
(2198 to 3252)
4.Secondary Outcome
Title Relative Change of UTXB2 in pg/mg Creatinine in Response to Aspirin
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
No data was collected for this outcome measure, as the study was terminated prematurely
Arm/Group Title Premenopausal Postmenopausal
Hide Arm/Group Description:
Premenopausal females in the cohort Aspirin 81 mg PO daily x 7 days
Postmenopausal females in the cohort Aspirin 81 mg PO daily x 7 days
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Premenopausal Postmenopausal
Hide Arm/Group Description Aspirin 81 mg PO daily x 7 days Aspirin 81 mg PO daily x 7 days
All-Cause Mortality
Premenopausal Postmenopausal
Affected / at Risk (%) Affected / at Risk (%)
Total   0/52 (0.00%)   0/48 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Premenopausal Postmenopausal
Affected / at Risk (%) Affected / at Risk (%)
Total   0/52 (0.00%)   0/48 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Premenopausal Postmenopausal
Affected / at Risk (%) Affected / at Risk (%)
Total   0/52 (0.00%)   0/48 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: RhondaLyn McLean
Organization: Johns Hopkins University School of Medicine
Phone: (215) 662-4949
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01875185     History of Changes
Other Study ID Numbers: NA_00079522
First Submitted: June 7, 2013
First Posted: June 11, 2013
Results First Submitted: August 15, 2017
Results First Posted: May 7, 2018
Last Update Posted: May 7, 2018