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Trial record 73 of 507 for:    ASPIRIN AND P2

PPI and Clopidogrel Response

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ClinicalTrials.gov Identifier: NCT01170533
Recruitment Status : Completed
First Posted : July 27, 2010
Results First Posted : March 6, 2012
Last Update Posted : March 6, 2012
Sponsor:
Collaborators:
Bristol-Myers Squibb
Sanofi
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label)
Condition Drug Interaction
Intervention Drug: omeprazole and pantoprazole
Enrollment 20
Recruitment Details  
Pre-assignment Details The proposed study will have a prospective, randomized, cross-over design.
Arm/Group Title Omeprazole Pantoprazole
Hide Arm/Group Description This was a prospective, open-label, two-sequence, three-period, randomized crossover study conducted in non-medicated healthy male subjects between the ages of 18 and 65 years. Subjects were randomized in a 1:1 fashion to take a PPI (omeprazole) concomitantly (CONC) or staggered (STAG) by 8-12 hours for one-week on a background of clopidogrel therapy. In particular, in the CONC regimen both drugs were taken in the morning, while in the STAG regimen clopidogrel was taken in the morning and the PPI (omeprazole)in the evening. After a 2-4 week washout period, subjects crossed-over treatment regimen. After completing these two treatment phases, subjects underwent another washout period of 2-4 weeks and were treated for 1 week with clopidogrel alone, without receiving PPI therapy (CLOP regimen). This was a prospective, open-label, two-sequence, three-period, randomized crossover study conducted in non-medicated healthy male subjects between the ages of 18 and 65 years. Subjects were randomized in a 1:1 fashion to take a PPI (pantoprazole) concomitantly (CONC) or staggered (STAG) by 8-12 hours for one-week on a background of clopidogrel therapy. In particular, in the CONC regimen both drugs were taken in the morning, while in the STAG regimen clopidogrel was taken in the morning and the PPI in the evening. After a 2-4 week washout period, subjects crossed-over treatment regimen. After completing these two treatment phases, subjects underwent another washout period of 2-4 weeks and were treated for 1 week with clopidogrel alone, without receiving PPI (pantoprazole) therapy (CLOP regimen).
Period Title: Omeprazole Cross-over
Started 20 0
Completed 20 0
Not Completed 0 0
Period Title: Pantoprazole Cross-over
Started 0 20 [1]
Completed 0 20
Not Completed 0 0
[1]
15 participants continued from omeprazole cross-over; the remaining 5 were new participants
Arm/Group Title All Study Participants
Hide Arm/Group Description

This was a prospective, open-label, two-sequence, three-period, randomized crossover study conducted in non-medicated healthy male subjects between the ages of 18 and 65 years. Subjects were randomized in a 1:1 fashion to take a PPI concomitantly (CONC) or staggered (STAG) by 8-12 hours for one-week on a background of clopidogrel therapy. In particular, in the CONC regimen both drugs were taken in the morning, while in the STAG regimen clopidogrel was taken in the morning and the PPI in the evening. After a 2-4 week washout period, subjects crossed-over treatment regimen. After completing these two treatment phases, subjects underwent another washout period of 2-4 weeks and were treated for 1 week with clopidogrel alone, without receiving PPI therapy (CLOP regimen).

The PPI could be omeprazole (first phase) or pantoprazole (second phase).

Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
<=18 years
0
   0.0%
Between 18 and 65 years
25
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants
Omeprazole cross-over n=20 34  (6)
Pantoprazole cross-over n=20 33  (5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
0
   0.0%
Male
25
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants
25
1.Primary Outcome
Title Platelet Function as Assessed by the P2Y12 Reactivity Index
Hide Description P2Y12 reactivity index which will be assessed by flow cytometry determination of vasodilator-stimulated phosphoprotein (VASP).
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
A sample size of 18 patients was required to be able to detect a 10% absolute difference in PRI between both regimens with 80% power and 2-sided significance level of 0.05, assuming a 15% standard deviation for the difference between regimens.
Arm/Group Title Omeprazole Concomitant Omeprazole Staggered Pantoprazole Concomitant Pantoprazole Staggered Clopidogrel Only (Omeprazole Phase) Clopidogrel Only (Pantoprazole Phase)
Hide Arm/Group Description:
Participants took omeprazole with clopidogrel concomitantly
Participants took omeprazole with clopidogrel staggered
Participants took pantoprazole with clopidogrel concomitantly
Participants took pantoprazole with clopidogrel staggered
Participants took clopidogrel only
Participants took clopidogrel only
Overall Number of Participants Analyzed 20 20 20 20 20 20
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of platelet reactivity index
56.1  (3.5) 61.6  (3.4) 56  (3.9) 61  (3.9) 48.8  (3.4) 61.0  (3.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Omeprazole Pantoprazole
Hide Arm/Group Description This was a prospective, open-label, two-sequence, three-period, randomized crossover study conducted in non-medicated healthy male subjects between the ages of 18 and 65 years. Subjects were randomized in a 1:1 fashion to take a PPI (omeprazole) concomitantly (CONC) or staggered (STAG) by 8-12 hours for one-week on a background of clopidogrel therapy. In particular, in the CONC regimen both drugs were taken in the morning, while in the STAG regimen clopidogrel was taken in the morning and the PPI (omeprazole)in the evening. After a 2-4 week washout period, subjects crossed-over treatment regimen. After completing these two treatment phases, subjects underwent another washout period of 2-4 weeks and were treated for 1 week with clopidogrel alone, without receiving PPI therapy (CLOP regimen). This was a prospective, open-label, two-sequence, three-period, randomized crossover study conducted in non-medicated healthy male subjects between the ages of 18 and 65 years. Subjects were randomized in a 1:1 fashion to take a PPI (pantoprazole) concomitantly (CONC) or staggered (STAG) by 8-12 hours for one-week on a background of clopidogrel therapy. In particular, in the CONC regimen both drugs were taken in the morning, while in the STAG regimen clopidogrel was taken in the morning and the PPI in the evening. After a 2-4 week washout period, subjects crossed-over treatment regimen. After completing these two treatment phases, subjects underwent another washout period of 2-4 weeks and were treated for 1 week with clopidogrel alone, without receiving PPI (pantoprazole) therapy (CLOP regimen).
All-Cause Mortality
Omeprazole Pantoprazole
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Omeprazole Pantoprazole
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Omeprazole Pantoprazole
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dominick J. Angiolillo, MD, PhD
Organization: University of Florida-Jacksonville
Phone: 904-244-3933
EMail: dominick.angiolillo@jax.ufl.edu
Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01170533     History of Changes
Other Study ID Numbers: UFJ 2009-2
First Submitted: July 23, 2010
First Posted: July 27, 2010
Results First Submitted: October 31, 2011
Results First Posted: March 6, 2012
Last Update Posted: March 6, 2012