Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-26 @ 9:23 AM
Study NCT ID:
NCT01896557
Status:
COMPLETED
Last Update Posted:
2018-07-06
First Post:
2013-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ranitidin Versus Omeprazole in Patients Taking Clopidogrel
Sponsor:
University of Sao Paulo General Hospital
Organization:
Study Overview
Official Title:
Possible Drug Interaction Between Clopidogrel and Ranitidin or Omeprazole in Patients With Stable Coronary Heart Disease: a Comparative Study
Status:
COMPLETED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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 Coronary Artery Bypass Graft (CABG) surgery and/or coronariography showing obstruction of at least 50 % in one of major epicardial vessels
* 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 coronary 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 Platelet Function Analyzer-100 (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.
Inclusion Criteria:
* Age \> 18 years old
* Coronary artery disease, defined as previous myocardial infarction and/or coronary angioplasty and/or Coronary Artery Bypass Graft (CABG) surgery and/or coronariography showing obstruction of at least 50 % in one of major epicardial vessels
* 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 coronary 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 Platelet Function Analyzer-100 (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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: