Coronary Heart DiseasePhase 4NCT00950339
Platelet Inhibitory Effect of Clopidogrel in Patients Treated With Omeprazole, Pantoprazole, or Famotidine
A Phase 4 study testing omeprazole, 20mg twice daily, famotidine 40mg twice daily and pantoprazole 40mg once daily in people with Coronary Heart Disease and GI Bleeding, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease, GI Bleeding
- What is being tested?
- omeprazole, 20mg twice daily, famotidine 40mg twice daily and pantoprazole 40mg once daily
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2009to Aug 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
In this study we will compare 3 different anti-acids regimens and their effect on platelet function
- Conditions
- Coronary Heart Disease, GI Bleeding
- Being tested
- omeprazole, 20mg twice daily, famotidine 40mg twice daily, pantoprazole 40mg once daily
- Keywords
- GI bleeding, clopidogrel, aspirin, prevention, angiography
- Medical subject headings
- Coronary Disease, Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omeprazole, 20mg twice dailyDrug
Also called PPI Platelet Inhibitory
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
famotidine 40mg twice dailyDrug
Also called PPI Platelet Inhibitory
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
pantoprazole 40mg once dailyDrug
Also called PPI Platelet Inhibitory
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
| Study group | Role | What they receive |
|---|---|---|
| 4 weeks of omeprazole, 20mg twice daily | Experimental | 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 Receives: Drug: omeprazole, 20mg twice daily; Drug: famotidine 40mg twice daily; Drug: pantoprazole 40mg once daily |
| 4 weeks of famotidine 40mg twice daily | Experimental | 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 Receives: Drug: omeprazole, 20mg twice daily; Drug: famotidine 40mg twice daily; Drug: pantoprazole 40mg once daily |
| 4 weeks of pantoprazole 40mg once daily | Experimental | 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 Receives: Drug: omeprazole, 20mg twice daily; Drug: famotidine 40mg twice daily; Drug: pantoprazole 40mg once daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet function as assessed by a CPA system
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionJun 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Tel Aviv Medical Center
- Responsible party
- Principal investigator, michal roll, Tel-Aviv Sourasky Medical Center
- Investigators
- Shmuel Banai, MD, Study chair, Tel Aviv Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950339
- Sponsor's protocol ID
- TASMC-09-SB-0196-09-TLV-CTIL
- Status last verified
- Jul 2016
- First submitted
- 19 Apr 2009
- Last updated
- 7 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 23630016
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Inhibitory Effect of Clopidogrel in Patients Treated With Omeprazole, Pantoprazole, or Famotidine
- ClinicalTrials.gov ID
- NCT00950339
- Acronym / sponsor ID
- TASMC-09-SB-0196-09-TLV-CTIL
- Conditions
- Coronary Heart Disease, GI Bleeding
- Keywords
- GI bleeding, clopidogrel, aspirin, prevention, angiography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Tel Aviv Medical Center
- Study start
- Aug 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 31 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 4 weeks of omeprazole, 20mg twice daily | Experimental | Drug: omeprazole, 20mg twice daily, Drug: famotidine 40mg twice daily, Drug: pantoprazole 40mg once dailyEach 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 |
| 4 weeks of famotidine 40mg twice daily | Experimental | Drug: omeprazole, 20mg twice daily, Drug: famotidine 40mg twice daily, Drug: pantoprazole 40mg once dailyEach 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 |
| 4 weeks of pantoprazole 40mg once daily | Experimental | Drug: omeprazole, 20mg twice daily, Drug: famotidine 40mg twice daily, Drug: pantoprazole 40mg once dailyEach 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| omeprazole, 20mg twice dailyAlso: PPI Platelet InhibitoryEach 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 | Drug | 4 weeks of famotidine 40mg twice daily, 4 weeks of omeprazole, 20mg twice daily, 4 weeks of pantoprazole 40mg once daily |
| famotidine 40mg twice dailyAlso: PPI Platelet InhibitoryEach 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 | Drug | 4 weeks of famotidine 40mg twice daily, 4 weeks of omeprazole, 20mg twice daily, 4 weeks of pantoprazole 40mg once daily |
| pantoprazole 40mg once dailyAlso: PPI Platelet InhibitoryEach 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 | Drug | 4 weeks of famotidine 40mg twice daily, 4 weeks of omeprazole, 20mg twice daily, 4 weeks of pantoprazole 40mg once daily |
Primary outcome
Platelet function as assessed by a CPA system
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2016.
- Derived from this study: PubMed 23630016Arbel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shmuel Banai, MD study chair
Tel Aviv Medical Center, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing omeprazole, 20mg twice daily, famotidine 40mg twice daily and pantoprazole 40mg once daily in people with Coronary Heart Disease and GI Bleeding, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet function as assessed by a CPA system (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00950339, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2016.