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Coronary Artery Disease | "Pharmacodynamic Comparison of Omeprazole Versus Pantoprazole on Platelet Reactivity in Patients With Acute Coronary Syndromes on Dual Antiplatelet Therapy With New P2Y12 Inhibitors" -Trial dOPPLER-

Coronary Artery Disease research study

What is the primary objective of this study?

Clopidogrel and Prasugrel are pro-drug necessitating conversion in active metabolites through CYP 450 system (CYP), particularly CYP3A and CYP2C19 isoforms. These drugs are platelet purinergic receptor antagonists, known as P2Y12. The link between active metabolite of Clopidogrel and Prasugrel to P2Y12 receptor prevents ADP receptor activation and inhibits several events leading to conformational change of platelets, therefore facilitating their activation and aggregation, that is the basis of acute coronary syndromes. Proton pump inhibitors (PPI) are actually considered principal agents reducing gastroenteric bleeding risk associated to antiplatelet therapy. Nevertheless the interaction between PPI and antiplatelet therapy has been object of interest. Several studies demonstrated PPI reduce efficacy of clopidogrel on platelet reactivity. Only few data about Prasugrel are available showing a minor effect of PPI on its antiplatelet activity than clopidogrel. Differing from prasugrel and clopidogrel, ticagrelor is a direct inhibitor of P2Y12, not necessitating biotransformation in the liver; therefore its interaction with PPI remains unclear. Interaction between omeprazole and clopidogrel seems related to high inhibitory activity of PPI on CYP2C19, interfering with the conversion of clopidogrel in its active metabolite.

Who is eligible to participate?

Inclusion Criteria: 1. All consecutive patients undergone PTCA in our institution in the period between July 2013 and December 2013 will be eligible to be enrolled. 2. Positive biomarker indicating myocardial necrosis. 3. All patients with prior myocardial infarction (MI) or coronary artery bypass grafting; coronary artery disease will be included. Exclusion Criteria: 1. Increased risk of bleeding (ex. active bleeding, major surgery <30 days). 2. Allergy or adverse reactions to administered drugs. 3. Other drugs or medications that affect CYP3A4 mediated drug metabolism. 4. Patients with missing follow-up data will be dropped out from the study.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Coronary Artery Disease

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Pantoprazole,os, 20 mg, once per day, for 30 days

Drug:Omeprazoleos, 20 mg, once per day, for 30 days

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

pantoprazolePatients were randomly assigned to omeprazole (20 mg day) or pantoprazole (20 mg day) for 30 days. After 1-week wash-out period to avoid any carryover effect, cross-over was performed, and patients were switched to the other drug which was continued for 30 days.

OmeprazolePatients were randomly assigned to omeprazole (20 mg day) or pantoprazole (20 mg day) for 30 days. After 1-week wash-out period to avoid any carryover effect, cross-over was performed, and patients were switched to the other drug which was continued for 30 days.

Study Status

Unknown status

Start Date: February 2014

Completed Date: April 2016

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Assessment of platelet reaction units

Secondary Outcome: Frequency of high platelet reactivity

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: University of Roma La Sapienza

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02028234

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