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Trial record 15 of 85 for:    ASPIRIN AND thromboxane

Validation of an Assay to Measure Cyclooxygenase-1 Activity

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ClinicalTrials.gov Identifier: NCT00761891
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : April 18, 2019
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
John Oates, Vanderbilt University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Healthy
Intervention Other: Chewable aspirin
Enrollment 64
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Chewable Aspirin
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81 mg daily for 2 weeks

Chewable aspirin: chewable aspirin 81mg daily for 2 weeks

Period Title: Overall Study
Started 64
Completed 54
Not Completed 10
Reason Not Completed
Withdrawal by Subject             10
Arm/Group Title Chewable Aspirin
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81 mg daily for 2 weeks

Chewable aspirin: chewable aspirin 81mg daily for 2 weeks

Overall Number of Baseline Participants 54
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[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 54 participants
33.5
(18 to 44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
Female 28
Male 26
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
American Indian or Alaska Native
0
   0.0%
Asian
5
   9.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
9
  16.7%
White
38
  70.4%
More than one race
0
   0.0%
Unknown or Not Reported
2
   3.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 54 participants
54
1.Primary Outcome
Title A Reference Range in Normal Volunteers Taking a Routine Clinical Dose of Aspirin (81mg Daily) for 2 Weeks
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Determine the level of Thromboxane B2 at which patients with a result above are not fully inhibited, and patients with a TxB2 level below are fully inhibited.

The reference range is the level of serum thromboxane at which participants below have fully inhibited COX-1 and participants above do not have fully inhibited COX-1 activity

Time Frame 2 weeks
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chewable Aspirin
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81 mg daily for 2 weeks
Overall Number of Participants Analyzed 54
Measure Type: Number
Number (75% Confidence Interval)
Unit of Measure: ng/ml
13
(4.988 to 13)
2.Secondary Outcome
Title Serum Thromboxane
Hide Description SerumTxB2: They are formed from the prostaglandin endoperoxides and cause platelet aggregation, contraction of arteries, and other biological effects.
Time Frame Baseline and at 2 weeks
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chewable Aspirin
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81mg aspirin daily for 2 weeks
Overall Number of Participants Analyzed 54
Mean (Standard Error)
Unit of Measure: ng/ml
baseline 284.2  (11.53)
2weeks 9.542  (0.92)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Enteric-coated Aspirin
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81 mg daily for 2 weeks

Enteric-coated aspirin: enteric-coated aspirin 81mg daily for 2 weeks

All-Cause Mortality
Enteric-coated Aspirin
Affected / at Risk (%)
Total   0/64 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Enteric-coated Aspirin
Affected / at Risk (%)
Total   0/64 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Enteric-coated Aspirin
Affected / at Risk (%)
Total   0/64 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Olivier Boutaud, PhD
Organization: Department of Pharmacology, School of Medicine, Vanderbilt University
Phone: 615-343-7398
Responsible Party: John Oates, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00761891     History of Changes
Other Study ID Numbers: 061190
First Submitted: September 26, 2008
First Posted: September 30, 2008
Results First Submitted: April 10, 2017
Results First Posted: April 18, 2019
Last Update Posted: April 18, 2019