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Trial record 17 of 1255 for:    ASPIRIN AND Platelet Aggregation

Pharmacogenomics of Antiplatelet Response - I (PARes-I)

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ClinicalTrials.gov Identifier: NCT01815008
Recruitment Status : Completed
First Posted : March 20, 2013
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: Prevention
Conditions Platelet Aggregation
Platelet Transcriptome
Coronary Artery Disease
Interventions Drug: Clopidogrel
Drug: Aspirin
Enrollment 19
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Clopidogrel
Hide Arm/Group Description

Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily

Clopidogrel: Clopidogrel 75 mg daily

Aspirin: Aspirin 81 mg daily

Period Title: Overall Study
Started 19 [1]
Completed 15 [2]
Not Completed 4
[1]
Had difficulty in completing enrollment
[2]
transcriptomic data was available on 9 participants only
Arm/Group Title Clopidogrel
Hide Arm/Group Description

Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily

Clopidogrel: Clopidogrel 75 mg daily

Aspirin: Aspirin 81 mg daily

Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
45.9  (5.2)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
6
  42.9%
Male
8
  57.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
African Americans Number Analyzed 14 participants
14
1.Primary Outcome
Title Difference in ADP-induced Platelet Aggregation
Hide Description ADP-induced platelet aggregation will be measured using impedance aggregometry in whole blood before and after 1-week of clopidogrel. The difference between the baseline and after clopidogrel therapy will be determined. Higher impedance represent higher platelet aggregation.
Time Frame at baseline and at 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
Data was collected before and after one week of clopidogrel. We found it difficult to enroll patients with low risk to the combined aspirin and clopidogrel and hence study was continued for the first week only.
Arm/Group Title Clopidogrel
Hide Arm/Group Description:

Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily

Clopidogrel: Clopidogrel 75 mg daily

Aspirin: Aspirin 81 mg daily

Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: Difference in ohms (Post-Pre)
-5.2  (4.1)
2.Secondary Outcome
Title Difference in Arachidonic Acid-induced Platelet Aggregation
Hide Description Arachidonic Acid-induced platelet aggregation will be measured using impedance aggregometry in whole blood before and after 1-week of clopidogrel. The difference between the baseline and after clopidogrel therapy will be determined
Time Frame At baseline and after 1-week
Hide Outcome Measure Data
Hide Analysis Population Description
Data was collected before and after one week of clopidogrel. We found it difficult to enroll patients with low risk to the combined aspirin and clopidogrel and hence study was continued for the first week only.
Arm/Group Title Clopidogrel
Hide Arm/Group Description:

Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily

Clopidogrel: Clopidogrel 75 mg daily

Note: The 2nd week of the study was not performed as we could not find low risk population in our cohort who could be given both anti-platelets without increased estimated risk of bleeding.

Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: Difference in ohms (Post-Pre)
-5.2  (4.4)
3.Secondary Outcome
Title Difference in Collagen-induced Platelet Aggregation
Hide Description Collagen-induced platelet aggregation will be measured using impedance aggregometry in whole blood before and after 1-week of clopidogrel. The difference between the baseline and after clopidogrel therapy will be determined
Time Frame At Baseline and at 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
Note: The 2nd week of the study was not performed as we could not find low risk population in our cohort who could be given both anti-platelets without increased estimated risk of bleeding.
Arm/Group Title Clopidogrel
Hide Arm/Group Description:

Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily

Clopidogrel: Clopidogrel 75 mg daily

Aspirin: Aspirin 81 mg daily

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: Difference in ohms (Post-Pre)
-1.13  (4.1)
4.Secondary Outcome
Title Changes in Platelet Transcriptome With Clopidogrel
Hide Description Platelet transcriptome will be examined before and after 1 week of therapy with clopidogrel and differences will be determined
Time Frame At baseline and at 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
Note: The 2nd week of the study was not performed as we could not find low risk population in our cohort who could be given both anti-platelets without increased estimated risk of bleeding. Note that the top most gene (CNOT2) with the lowest p-value is being reported.
Arm/Group Title Clopidogrel
Hide Arm/Group Description:

Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily

Clopidogrel: Clopidogrel 75 mg daily

Aspirin: Aspirin 81 mg daily

Note: The 2nd week of the study was not performed as we could not find low risk population in our cohort who could be given both anti-platelets without increased estimated risk of bleeding.

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: FPKM
13.7  (3.55)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Clopidogrel
Hide Arm/Group Description

Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily

Clopidogrel: Clopidogrel 75 mg daily

Aspirin: Aspirin 81 mg daily

All-Cause Mortality
Clopidogrel
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Clopidogrel
Affected / at Risk (%)
Total   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Clopidogrel
Affected / at Risk (%)
Total   0/14 (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: NCT01815008     History of Changes
Other Study ID Numbers: K23HL105897-PARes-I
K23HL105897 ( U.S. NIH Grant/Contract )
First Submitted: March 18, 2013
First Posted: March 20, 2013
Results First Submitted: August 1, 2016
Results First Posted: January 9, 2017
Last Update Posted: January 9, 2017