Ranitidin Versus Omeprazole in Patients Taking Clopidogrel

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by University of Sao Paulo General Hospital.
Recruitment status was  Active, not recruiting
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: July 10, 2013
Last verified: October 2011

June 19, 2013
July 10, 2013
October 2011
June 2013   (final data collection date for primary outcome measure)
Comparing platelet function of patients on dual antiplatelet therapy with ASA + clopidogrel, between the groups ranitidin and omeprazole, using VerifyNow method. [ Time Frame: 1 week after drug exposure ] [ Designated as safety issue: No ]
One week after starting double-blind, double-dummy, randomized therapy with ranitidin or omeprazole on patients treated with DAPT, platelet function will be compared with the method VerifyNow(Accumetrics - USA).
Same as current
Complete list of historical versions of study NCT01896557 on ClinicalTrials.gov Archive Site
Comparison of the primary outcome with other two methods of platelet aggregability: PFA-100 and bioimpedance aggregometry [ Time Frame: 1 week after drug exposure ] [ Designated as safety issue: No ]
After 1 week of randomization to ranitidin or omeprazole, the platelet function will also be analysed by two other methods: PFA-100 (Siemens-USA) and bioimpedance aggregometry.
Same as current
Comparing the main outcome on pre-specified subgroups [ Time Frame: 1 week after drug exposure ] [ Designated as safety issue: No ]

The main outcome will be compared on pre-specified subgroups:

  • elderly (age > 65 yrs-old) versus non-elderly
  • male versus female
  • smoking versus non-smoking patients
  • obese (BMI > 30 kg/m2) versus non-obese
  • diabetic versus non-diabetic
  • patients in use or not in use of statins
  • presence or not of genetic polymorphisms on cytochrome CYP2C19.
Same as current
 
Ranitidin Versus Omeprazole in Patients Taking Clopidogrel
Possible Drug Interaction Between Clopidogrel and Ranitidin or Omeprazole in Patients With Stable Coronary Heart Disease: a Comparative Study

Previous reports have shown a possible drug interaction between clopidogrel and proton pump inhibitors (PPI´s), which could result in increased number of adverse cardiovascular events among patients on dual antiplatelet therapy(DAPT). Because of this, ranitidin has been proposed as an alternative drug to PPI´s for prophylaxis of gastrointestinal bleeding in patients who need DAPT. The study´s aim is to test the hypothesis that ranitidin doesn´t have any influence on clopidogrel pharmacodynamic.

Study population: 100 patients with Stable Coronary Artery Disease from Heart Institute

Inclusion Criteria:

  • Age > 18 years old
  • Coronary artery disease, defined as previous myocardial infarction and/or coronary angioplasty and/or CABG surgery and/or coronariography showing obstruction of at least 50 % in one of major epicardial vesses
  • Treatment with Acetylsalicylic Acid (ASA) 100 mg/day

Exclusion Criteria:

  • Use in the last 7 days of oral anticoagulant or any other antiplatelet drug beside ASA
  • Previous utilization of PPI or ranitidine in the last 7 days before randomization
  • Active bleeding
  • Pregnancy or woman of childbearing age without contraceptive method
  • Hemoglobin < 10 g/dL or hematocrit < 30 %, hematocrit > 50 %, platelets < 100.000/mm3 or > 500.000/mm3; creatinin clearance < 50 ml/minute
  • Percutaneous coronary intervention (PCI) on the last 30 days before randomization (or PCI on the last year when drug-eluted stents are used); CABG surgery on the last 90 days; acute coronay syndrome on the last 60 days
  • Active malignant neoplasm
  • Active peptic ulcer disease on the last 60 days or upper gastrointestinal bleeding any time in life
  • Known allergy to the drugs clopidogrel, ranitidine or omeprazole
  • Refuse to participate in the study]

Methodology: The study has a double-blind, double-dummy prospective design. Clopidogrel action is evaluated by platelet function tests: VerifyNow, bioimpedance aggregometry and PFA-100. The patients have measurements of platelet function on three moments: before starting clopidogrel; 1 week after DAPT with clopidogrel (without loading dose) plus ASA; and after 1 week of randomization to ranitidin 150 mg bid or omeprazole 20 mg bid.

Interventional
Phase 4
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
VA Drug Interactions [VA Drug Interaction]
Drug: omeprazole
Influence of omeprazole on clopidogrel pharmacodynamics will be evaluated.
Other Names:
  • Peprazol
  • Losec
  • PPI
Experimental: 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.
Intervention: Drug: omeprazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
August 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > 18 years old
  • Coronary artery disease, defined as previous myocardial infarction and/or coronary angioplasty and/or CABG surgery and/or coronariography showing obstruction of at least 50 % in one of major epicardial vesses
  • Treatment with Acetylsalicylic Acid (ASA) 100 mg/day

Exclusion Criteria:

  • Use on the last 7 days of any other antiplatelet drug beside ASA or oral anticoagulant
  • Previous utilization of PPI or ranitidine in the last 7 days before randomization
  • Any active bleeding
  • Pregnancy or woman of childbearing age without contraceptive method
  • Hemoglobin < 10 g/dL or hematocrit < 30 %, hematocrit > 50 %, platelets < 100.000/mm3 or > 500.000/mm3; creatinin clearance < 50 ml/minute
  • Percutaneous coronary intervention (PCI) on the last 30 days before randomization (or PCI on the last year when drug-eluted stents are used); CABG surgery on the last 90 days; acute coronay syndrome on the last 60 days
  • Active malignant neoplasm
  • Active peptic ulcer disease on the last 60 days or upper gastrointestinal bleeding any time in life
  • Known allergy to the drugs clopidogrel, ranitidine or omeprazole
  • Refuse to participate in the study
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01896557
0136/11
Yes
University of Sao Paulo General Hospital
University of Sao Paulo General Hospital
InCor Heart Institute
Principal Investigator: José C Nicolau, Professor Director of Acute Coronary Care Unit
University of Sao Paulo General Hospital
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP