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Trial record 5 of 87 for:    ASPIRIN AND thromboxane

Aspirin Resistance in Coronary Artery Disease

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ClinicalTrials.gov Identifier: NCT00753935
Recruitment Status : Completed
First Posted : September 17, 2008
Results First Posted : April 19, 2018
Last Update Posted : April 19, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
John Oates, Vanderbilt University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Basic Science
Condition Coronary Artery Disease
Interventions Drug: enteric-coated aspirin
Drug: Chewable aspirin
Enrollment 92
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Enteric-coated Aspirin Chewable Aspirin
Hide Arm/Group Description

patients received enteric-coated aspirin 81 mg qd for 2 weeks

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

Patients received chewable aspirin 81 mg qd for 2 weeks

Chewable aspirin: chewable aspirin 81mg daily for 2 weeks

Period Title: Overall Study
Started 45 47
Completed 45 47
Not Completed 0 0
Arm/Group Title Enteric-coated Aspirin Chewable Aspirin Total
Hide Arm/Group Description patients with coronary artery disease received enteric-coated aspirin 81 mg qd for 2 weeks Patients with coronary artery disease received chewable aspirin 81 mg qd for 2 weeks Total of all reporting groups
Overall Number of Baseline Participants 45 47 92
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 45 participants 47 participants 92 participants
62
(56 to 69)
68
(59 to 75)
65
(56 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 47 participants 92 participants
Female
12
  26.7%
14
  29.8%
26
  28.3%
Male
33
  73.3%
33
  70.2%
66
  71.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 47 participants 92 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
8
  17.8%
4
   8.5%
12
  13.0%
White
36
  80.0%
42
  89.4%
78
  84.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   2.2%
1
   2.1%
2
   2.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 45 participants 47 participants 92 participants
45 47 92
1.Primary Outcome
Title Change in Serum Thromboxane B2
Hide Description Thromboxane A2, the major product of cyclooxygenase cytochrome oxidase (COX-1) in platelets, induces platelet aggregation. Thromboxane B2 is an inactive metabolite/product of thromboxane A2. This primary outcome measures the extent of inhibition of platelet COX-1 by measuring the amount of the metabolite thromboxane B2 in serum.
Time Frame after 2 weeks on aspirin
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enteric-coated Aspirin Chewable Aspirin
Hide Arm/Group Description:

patients received enteric-coated aspirin 81 mg qd for 2 weeks

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

Patients received chewable aspirin 81 mg qd for 2 weeks

Chewable aspirin: chewable aspirin 81mg daily for 2 weeks

Overall Number of Participants Analyzed 45 47
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
5.02
(3.36 to 7.86)
2.78
(1.60 to 4.76)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enteric-coated Aspirin, Chewable Aspirin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Wilcoxon rank-sum
Comments [Not Specified]
Time Frame 2 years and 11 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Enteric-coated Aspirin Chewable Aspirin
Hide Arm/Group Description patients with coronary artery disease received enteric-coated aspirin 81 mg qd for 2 weeks Patients with coronary artery disease received chewable aspirin 81 mg qd for 2 weeks
All-Cause Mortality
Enteric-coated Aspirin Chewable Aspirin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/47 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Enteric-coated Aspirin Chewable Aspirin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/47 (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 Chewable Aspirin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/47 (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
Layout table for Results Point of Contact information
Name/Title: John A. Oates, MD
Organization: Vanderbilt_University MC
Phone: 615 4343 4847
EMail: john.oates@vanderbilt.edu
Layout table for additonal information
Responsible Party: John Oates, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00753935     History of Changes
Other Study ID Numbers: 040065
5P50HL081009-03 ( U.S. NIH Grant/Contract )
First Submitted: September 15, 2008
First Posted: September 17, 2008
Results First Submitted: April 7, 2017
Results First Posted: April 19, 2018
Last Update Posted: April 19, 2018