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Pharmacogenomics of Antiplatelet Response (PARes-III)

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ClinicalTrials.gov Identifier: NCT02234427
Recruitment Status : Completed
First Posted : September 9, 2014
Results First Posted : January 9, 2017
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
Rehan Qayyum, Johns Hopkins University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Atherosclerosis
Intervention Drug: Aspirin
Enrollment 34
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aspirin
Hide Arm/Group Description Aspirin: 2-week aspirin therapy (81mg/day)
Period Title: Overall Study
Started 34
Completed 33 [1]
Not Completed 1
[1]
One individual withdrew after first visit
Arm/Group Title Aspirin
Hide Arm/Group Description Aspirin: 2-week aspirin therapy (81mg/day)
Overall Number of Baseline Participants 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants
53.4  (10.3)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Female
17
  50.0%
Male
17
  50.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants
African Americans 17
Caucasians 17
1.Primary Outcome
Title Differential Gene Expression
Hide Description Differences in platelet transcriptome before and after 2-week aspirin therapy The expression levels of genes before aspirin therapy was compared with the expression level of the genes after aspirin therapy. The expression levels were measured using the FPKM unit (Fragments Per Kilobase of transcript per Million mapped reads). The gene with the highest difference (pre vs. post) in FPKM is being reported with name in the units area and the actual difference in the number area
Time Frame 2-weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The data were analyzed combining results from two studies (24 from this study and additional 33 individuals from study NCT01894555; total population size = 57) to improve the power to detect a difference. Same results are reported for the two studies. Note that the top most gene (HBG1) with the lowest p-value is being reported.
Arm/Group Title Aspirin
Hide Arm/Group Description:
Aspirin: 2-week aspirin therapy (81mg/day)
Overall Number of Participants Analyzed 57
Mean (Standard Error)
Unit of Measure: FPKM for HBG1 Gene
77.1  (19.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin
Comments Null Hypothesis: There is no difference in gene expression before and after aspirin therapy
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.000005
Comments Above noted p-value is adjusted for multiple comparisons. Analysis was performed using the TopHat/Cufflinks pipeline. The differential expression algorithm uses a beta distribution and the overdispersion with a negative binomial distribution.
Method negative binomial
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aspirin
Hide Arm/Group Description Aspirin: 2-week aspirin therapy (81mg/day)
All-Cause Mortality
Aspirin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aspirin
Affected / at Risk (%)
Total   0/34 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Aspirin
Affected / at Risk (%)
Total   0/34 (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: Rehan Qayyum
Organization: Johns Hopkins School of Medicine
Phone: 410-955-7781
Responsible Party: Rehan Qayyum, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02234427     History of Changes
Other Study ID Numbers: PARes-III
First Submitted: September 5, 2014
First Posted: September 9, 2014
Results First Submitted: August 1, 2016
Results First Posted: January 9, 2017
Last Update Posted: January 9, 2017