"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-

NCT02028234 | Unknown Phase 4

• 1 other identifier: 010114
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Assessment of platelet reaction units

  Absolute changes in platelet reactivity (expressed as P2Y(12) reaction units by the point-of-care VerifyNow assay \[Accumetrics, San Diego, California\]

  After 30 days of treatment with each drug

Secondary Outcomes (1)

• Frequency of high platelet reactivity

  After 30 days of treatment with each drug

Study Arms (2)

pantoprazole

ACTIVE COMPARATOR

Patients 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.

Drug: Pantoprazole,; Drug: Omeprazole

Omeprazole

ACTIVE COMPARATOR

Patients 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.

Drug: Pantoprazole,; Drug: Omeprazole

Interventions

Pantoprazole, DRUG

os, 20 mg, once per day, for 30 days

Also known as: pantorc

Omeprazole; pantoprazole

Omeprazole DRUG

os, 20 mg, once per day, for 30 days

Also known as: lansox

Omeprazole; pantoprazole

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All consecutive patients undergone PTCA in our institution in the period between July 2013 and December 2013 will be eligible to be enrolled.
• Positive biomarker indicating myocardial necrosis.
• All patients with prior myocardial infarction (MI) or coronary artery bypass grafting; coronary artery disease will be included.

You may not qualify if:

• Increased risk of bleeding (ex. active bleeding, major surgery \<30 days).
• Allergy or adverse reactions to administered drugs.
• Other drugs or medications that affect CYP3A4 mediated drug metabolism.
• Patients with missing follow-up data will be dropped out from the study.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Sapienza Univeristy of Rome

Rome, Italy, 00166, Italy

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Pantoprazole; Omeprazole

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

MD MARINA POLACCO

CONTACT

+393333347960; dott.mpolacco@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 2, 2014
• First Posted: January 7, 2014
• Study Start: February 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: April 1, 2016
• Last Updated: January 8, 2014

Record last verified: 2014-01

Locations

IT (1)