Ranitidin Versus Omeprazole in Patients Taking Clopidogrel

This study has been completed.
Sponsor:
Collaborator:
InCor Heart Institute
Information provided by (Responsible Party):
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01896557
First received: June 19, 2013
Last updated: May 12, 2016
Last verified: October 2011
Results First Received: May 28, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: VA Drug Interactions [VA Drug Interaction]
Coronary Artery Disease
Interventions: Drug: omeprazole
Drug: Ranitidine
Drug: Clopidogrel

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Omeprazole

Omeprazole 20 mg (oral route) twice a day will be given to the subjects for one week. This intervention will be compared with ranitidin 150 mg (oral route) twice a day.

omeprazole: Influence of omeprazole on clopidogrel pharmacodynamics will be evaluated.

Ranitidine Ranitidine 150 mg BID oral route was added to clopidogrel.

Participant Flow for 2 periods

Period 1:   Clopidogrel Alone
    Omeprazole     Ranitidine  
STARTED     44     48  
COMPLETED     43     48  
NOT COMPLETED     1     0  
Adverse Event                 1                 0  

Period 2:   Clopidogrel + GI Protector
    Omeprazole     Ranitidine  
STARTED     43     48  
COMPLETED     41     44  
NOT COMPLETED     2     4  
low adherence                 1                 1  
Reading error                 1                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Omeprazole

Omeprazole 20 mg (oral route) twice a day will be given to the subjects for one week. This intervention will be compared with ranitidin 150 mg (oral route) twice a day.

omeprazole: Influence of omeprazole on clopidogrel pharmacodynamics will be evaluated.

Ranitidine Ranitidine 150 mg BID oral route was added to clopidogrel.
Total Total of all reporting groups

Baseline Measures
    Omeprazole     Ranitidine     Total  
Number of Participants  
[units: participants]
  41     44     85  
Age [1]
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     22     24     46  
>=65 years     19     20     39  
Age  
[units: years]
Mean (Standard Deviation)
  62.6  (10.9)     62.5  (8.9)     62.6  (9.9)  
Gender  
[units: participants]
     
Female     9     14     23  
Male     32     30     62  
[1] Age in years



  Outcome Measures
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1.  Primary:   Comparing Platelet Function of Patients on Dual Antiplatelet Therapy With ASA + Clopidogrel, Between the Groups Ranitidin and Omeprazole, Using VerifyNow Method.   [ Time Frame: One week after drug exposure (omeprazole/ranitidine); 2 weeks after baseline ]

2.  Primary:   Comparing Platelet Function of Patients on Dual Antiplatelet Therapy With ASA + Clopidogrel, Between the Groups Ranitidin and Omeprazole, Using VerifyNow Method.   [ Time Frame: One week after drug exposure (omeprazole/ranitidine); 2 weeks after baseline ]

3.  Secondary:   Comparison of the Primary Outcome With Other Two Methods of Platelet Aggregability: PFA-100 and Bioimpedance Aggregometry   [ Time Frame: 1 week after drug exposure ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Other Pre-specified:   Comparing the Main Outcome on Pre-specified Subgroups   [ Time Frame: 1 week after drug exposure ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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: Remo Holanda de Mendonca Furtado
Organization: Heart Institute of University of Sao Paulo Medical School
phone: +5511 26615058
e-mail: remo_holanda@hotmail.com



Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01896557     History of Changes
Other Study ID Numbers: 0136/11
Study First Received: June 19, 2013
Results First Received: May 28, 2015
Last Updated: May 12, 2016
Health Authority: Brazil: National Committee of Ethics in Research