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Platelet Inhibitory Effect of Clopidogrel in Patients Treated With Omeprazole, Pantoprazole, or Famotidine

Primary Purpose

Coronary Heart Disease, GI Bleeding

Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
omeprazole, 20mg twice daily
famotidine 40mg twice daily
pantoprazole 40mg once daily
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease focused on measuring GI bleeding, clopidogrel, aspirin, prevention, angiography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject is at least 18 years old.
  2. Subject is willing to comply with pre-specified follow-up evaluation and can be contacted by telephone.
  3. Use of Clopidogrel (>=75mg) and Aspirin(>=75mg) for at least 1 month.

Exclusion Criteria:

  1. Known allergy to PPI of H2 blockers
  2. Known thrombocytopenia or thrombocytopathia
  3. Subject is currently enrolled in another investigational study of a new drug, biologic or device at the time of study screening. NOTE: Subjects who are participating in the long term follow-up phase of a previously investigational and now FDA-approved product are not excluded by this criterion.
  4. Subject with symptomatic heart failure of LVEF ≤ 25%
  5. Acute myocardial infarction within the past 30 days.
  6. No acute inflammatory event during the past month (e.g. infection, autoimmune or acute coronary event)
  7. Concurrent medical condition with a life expectancy of less than 12 months.
  8. Known severe renal failure (serum creatinine level >2.5 mg/dl).
  9. History of bleeding diathesis or coagulopathy or inability or unwillingness to receive blood transfusions.
  10. Evidence of active gastrointestinal bleeding or a history of such bleeding that is not known to have been treated and proven to have resolved.
  11. History of hepatitis (viral, ischemic or chemically-induced); clinical jaundice, history of cirrhosis.
  12. Patient treated with anticoagulant medication (Coumadin, LMWH)

Sites / Locations

  • Tel Aviv Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

4 weeks of omeprazole, 20mg twice daily

4 weeks of famotidine 40mg twice daily

4 weeks of pantoprazole 40mg once daily

Arm Description

Each patient will undergo 3 phases of drug therapy: A- 4 weeks of PPI treatment (omeprazole, 20mg twice daily)) B- 4 weeks of H2 blocker treatment (famotidine 40mg twice daily) C- 4 weeks of PPI treatment (pantoprazole 40mg once daily). At the end of each phase- each patient will undergo the following evaluation: Platelet reactivity

Each patient will undergo 3 phases of drug therapy: A- 4 weeks of PPI treatment (omeprazole, 20mg twice daily)) B- 4 weeks of H2 blocker treatment (famotidine 40mg twice daily) C- 4 weeks of PPI treatment (pantoprazole 40mg once daily). At the end of each phase- each patient will undergo the following evaluation: Platelet reactivity

Each patient will undergo 3 phases of drug therapy: A- 4 weeks of PPI treatment (omeprazole, 20mg twice daily)) B- 4 weeks of H2 blocker treatment (famotidine 40mg twice daily) C- 4 weeks of PPI treatment (pantoprazole 40mg once daily). At the end of each phase- each patient will undergo the following evaluation: Platelet reactivity

Outcomes

Primary Outcome Measures

Platelet function as assessed by a CPA system

Secondary Outcome Measures

Full Information

First Posted
April 19, 2009
Last Updated
July 6, 2016
Sponsor
Tel-Aviv Sourasky Medical Center
Collaborators
Tel Aviv Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00950339
Brief Title
Platelet Inhibitory Effect of Clopidogrel in Patients Treated With Omeprazole, Pantoprazole, or Famotidine
Official Title
Platelet Inhibitory Effect of Clopidogrel in Patients Treated With Omeprazole, Pantoprazole, or Famotidine
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
Collaborators
Tel Aviv Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Current guidelines recommend the addition of proton pump inhibitors (PPI) to patients taking double anti-platelet therapy (Aspirin and Clopidogrel) to prevent upper GI bleeding1. Many post percutaneous coronary intervention (PCI) patients are treated with dual anti-platelet medications as well as PPI to prevent upper GI bleeding. Recently, it was shown that PPI interact with the P450 system in the liver and reduce the platelet inhibitory effect of Clopidogrel2,3. Clopidogrel is activated by CYP2C19, which also metabolizes PPI4. Furthermore, a recent article showed increased mortality in patients taking PPI and clopidogrel compared with patients taking clopidogrel without PPI protection5. The degree of reduction in the platelet inhibitory properties of clopidogrel might vary among the different PPI4. The use of PPI for GI protection in patients treated with dual anti-platelet therapy is not based on randomized trials, but rather on expert opinion. Since H2 blockers are also effective in preventing acid secretion and are not known to interact with the P450 system that affects clopidogrel, the investigators hypothesized that these group of drugs will not interfere with the positive antiplatelet effects of clopidogrel and therefore will offer a good alternative treatment option.
Detailed Description
In this study we will compare 3 different anti-acids regimens and their effect on platelet function

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease, GI Bleeding
Keywords
GI bleeding, clopidogrel, aspirin, prevention, angiography

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
4 weeks of omeprazole, 20mg twice daily
Arm Type
Experimental
Arm Description
Each patient will undergo 3 phases of drug therapy: A- 4 weeks of PPI treatment (omeprazole, 20mg twice daily)) B- 4 weeks of H2 blocker treatment (famotidine 40mg twice daily) C- 4 weeks of PPI treatment (pantoprazole 40mg once daily). At the end of each phase- each patient will undergo the following evaluation: Platelet reactivity
Arm Title
4 weeks of famotidine 40mg twice daily
Arm Type
Experimental
Arm Description
Each patient will undergo 3 phases of drug therapy: A- 4 weeks of PPI treatment (omeprazole, 20mg twice daily)) B- 4 weeks of H2 blocker treatment (famotidine 40mg twice daily) C- 4 weeks of PPI treatment (pantoprazole 40mg once daily). At the end of each phase- each patient will undergo the following evaluation: Platelet reactivity
Arm Title
4 weeks of pantoprazole 40mg once daily
Arm Type
Experimental
Arm Description
Each patient will undergo 3 phases of drug therapy: A- 4 weeks of PPI treatment (omeprazole, 20mg twice daily)) B- 4 weeks of H2 blocker treatment (famotidine 40mg twice daily) C- 4 weeks of PPI treatment (pantoprazole 40mg once daily). At the end of each phase- each patient will undergo the following evaluation: Platelet reactivity
Intervention Type
Drug
Intervention Name(s)
omeprazole, 20mg twice daily
Other Intervention Name(s)
PPI Platelet Inhibitory
Intervention Description
Each patient will undergo 3 phases of drug therapy: A- 4 weeks of PPI treatment (omeprazole, 20mg twice daily)) B- 4 weeks of H2 blocker treatment (famotidine 40mg twice daily) C- 4 weeks of PPI treatment (pantoprazole 40mg once daily). At the end of each phase- each patient will undergo the following evaluation: Platelet reactivity
Intervention Type
Drug
Intervention Name(s)
famotidine 40mg twice daily
Other Intervention Name(s)
PPI Platelet Inhibitory
Intervention Description
Each patient will undergo 3 phases of drug therapy: A- 4 weeks of PPI treatment (omeprazole, 20mg twice daily)) B- 4 weeks of H2 blocker treatment (famotidine 40mg twice daily) C- 4 weeks of PPI treatment (pantoprazole 40mg once daily). At the end of each phase- each patient will undergo the following evaluation: Platelet reactivity
Intervention Type
Drug
Intervention Name(s)
pantoprazole 40mg once daily
Other Intervention Name(s)
PPI Platelet Inhibitory
Intervention Description
Each patient will undergo 3 phases of drug therapy: A- 4 weeks of PPI treatment (omeprazole, 20mg twice daily)) B- 4 weeks of H2 blocker treatment (famotidine 40mg twice daily) C- 4 weeks of PPI treatment (pantoprazole 40mg once daily). At the end of each phase- each patient will undergo the following evaluation: Platelet reactivity
Primary Outcome Measure Information:
Title
Platelet function as assessed by a CPA system
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is at least 18 years old. Subject is willing to comply with pre-specified follow-up evaluation and can be contacted by telephone. Use of Clopidogrel (>=75mg) and Aspirin(>=75mg) for at least 1 month. Exclusion Criteria: Known allergy to PPI of H2 blockers Known thrombocytopenia or thrombocytopathia Subject is currently enrolled in another investigational study of a new drug, biologic or device at the time of study screening. NOTE: Subjects who are participating in the long term follow-up phase of a previously investigational and now FDA-approved product are not excluded by this criterion. Subject with symptomatic heart failure of LVEF ≤ 25% Acute myocardial infarction within the past 30 days. No acute inflammatory event during the past month (e.g. infection, autoimmune or acute coronary event) Concurrent medical condition with a life expectancy of less than 12 months. Known severe renal failure (serum creatinine level >2.5 mg/dl). History of bleeding diathesis or coagulopathy or inability or unwillingness to receive blood transfusions. Evidence of active gastrointestinal bleeding or a history of such bleeding that is not known to have been treated and proven to have resolved. History of hepatitis (viral, ischemic or chemically-induced); clinical jaundice, history of cirrhosis. Patient treated with anticoagulant medication (Coumadin, LMWH)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shmuel Banai, MD
Organizational Affiliation
Tel Aviv Medical Center, Israel
Official's Role
Study Chair
Facility Information:
Facility Name
Tel Aviv Medical Center
City
Tel Aviv
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23630016
Citation
Arbel Y, Birati EY, Finkelstein A, Halkin A, Kletzel H, Abramowitz Y, Berliner S, Deutsch V, Herz I, Keren G, Banai S. Platelet inhibitory effect of clopidogrel in patients treated with omeprazole, pantoprazole, and famotidine: a prospective, randomized, crossover study. Clin Cardiol. 2013 Jun;36(6):342-6. doi: 10.1002/clc.22117. Epub 2013 Apr 29.
Results Reference
derived

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Platelet Inhibitory Effect of Clopidogrel in Patients Treated With Omeprazole, Pantoprazole, or Famotidine

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