Ignite Creation Date:
2024-05-05 @ 11:08 PM
Last Modification Date:
2024-10-26 @ 10:29 AM
Study NCT ID:
NCT01269333
Status:
COMPLETED
Last Update Posted:
2015-08-19
First Post:
2011-01-03
Brief Title:
Impact of Omeprazole and Fluvoxamine on Platelet Response to Clopidogrel
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
Impact of Omeprazole and Fluvoxamine on Platelet Response to Clopidogrel a Randomized Double-blind Placebo Controlled Crossover Trial
Status:
COMPLETED
Status Verified Date:
2015-08
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:
Clopidogrel is a platelets inhibitor that is widely used particularly during and after acute coronary events and coronary interventions Several studies have shown that some patients are resistant to clopidogrel The resistance mechanism is not entirely clear yet but at least in part it is related to interactions between medications
Omeprazole is a member in the family of gastric proton pump inhibitor PPI that are widely used in patients who receive combination of aspirin and clopidogrel in order to protect the stomach lining and prevent GI bleeding Data from studies on platelet aggregation indicate that treatment with omeprazole may cause partial resistance to clopidogrel and increase risk for recurrent cardiovascular events in patients after coronary interventions Recently the FDA published struck to avoid cross clopidogrel and omeprazole treatment for fear of reduction efficiency Nevertheless there are several studies that do not support increased risk of cardiovascular events among patients taking omeprazole and clopidogrel as the COGENT trial which is the single prospective controlled study that assessed the clinical implication of this drugs interaction
The accepted Mechanism of interaction between omeprazole and clopidogrel is disturbance to create clopidogrel active metabolite through CYP2C19 inhibition by omeprazole fluvoxamine - is a member in SSRIs family and a potent inhibitor of the CYP2C19 In vivo studies compared the degree of decomposition proguanil a CYP2C19 indicator by fluvoxamine and omeprazole found constant inhibition- Ki 10 Micromol L for of Omeprazole versus constant inhibition- Ki 069 Micromol L for fluvoxamine This indicates a more potent inhibition of CYP2C19 in vivo of fluvoxamine compared to omeprazole It is important to note that so far there is no date in literature studies demonstrates that there is any interaction between fluvoxamine and other CYP2C19 inhibitors and Clopidogrel
Research goals
To assess the impact of fluvoxamine and omeprazole on platelet reactivity in healthy individuals treated with clopidogrel
To verify weather the mechanism of omeprazole-clopidogrel interaction is related to CYP2C19 inhibition
Study design
Randomized blinded placebo-controlled crossover trial on healthy volunteers The response to clopidogrel will be assessed using two methods in subjects receiving clopidogrel and one of the study drugs fluvoxamine omeprazole or placebo
Omeprazole is a member in the family of gastric proton pump inhibitor PPI that are widely used in patients who receive combination of aspirin and clopidogrel in order to protect the stomach lining and prevent GI bleeding Data from studies on platelet aggregation indicate that treatment with omeprazole may cause partial resistance to clopidogrel and increase risk for recurrent cardiovascular events in patients after coronary interventions Recently the FDA published struck to avoid cross clopidogrel and omeprazole treatment for fear of reduction efficiency Nevertheless there are several studies that do not support increased risk of cardiovascular events among patients taking omeprazole and clopidogrel as the COGENT trial which is the single prospective controlled study that assessed the clinical implication of this drugs interaction
The accepted Mechanism of interaction between omeprazole and clopidogrel is disturbance to create clopidogrel active metabolite through CYP2C19 inhibition by omeprazole fluvoxamine - is a member in SSRIs family and a potent inhibitor of the CYP2C19 In vivo studies compared the degree of decomposition proguanil a CYP2C19 indicator by fluvoxamine and omeprazole found constant inhibition- Ki 10 Micromol L for of Omeprazole versus constant inhibition- Ki 069 Micromol L for fluvoxamine This indicates a more potent inhibition of CYP2C19 in vivo of fluvoxamine compared to omeprazole It is important to note that so far there is no date in literature studies demonstrates that there is any interaction between fluvoxamine and other CYP2C19 inhibitors and Clopidogrel
Research goals
To assess the impact of fluvoxamine and omeprazole on platelet reactivity in healthy individuals treated with clopidogrel
To verify weather the mechanism of omeprazole-clopidogrel interaction is related to CYP2C19 inhibition
Study design
Randomized blinded placebo-controlled crossover trial on healthy volunteers The response to clopidogrel will be assessed using two methods in subjects receiving clopidogrel and one of the study drugs fluvoxamine omeprazole or placebo
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None