Evaluation of the Influence of Statins and Proton Pump Inhibitors on Clopidogrel Antiplatelet Effects
Information source: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Artery Disease
Intervention: Rosuvastatin-omeprazole (Drug); Rosuvastatin-pantoprazole (Drug); Rosuvastatin-esomeprazole (Drug); Rosuvastatin-ranitidine (Drug); Atorvastatin-omeprazole (Drug); Atorvastatin-pantoprazole (Drug); Atorvastatin-esomeprazole (Drug); Atorvastatin-ranitidine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec Official(s) and/or principal investigator(s):
Jean-Pierre Dery, MD, MHS, Principal Investigator, Affiliation: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Overall contact:
Ugo Dery, PhD, Phone: 4186568711, Ext: 3383, Email: ugo.dery@criucpq.ulaval.ca
Summary
There is conflicting evidence in the literature suggesting that the use of proton pump
inhibitors (PPIs), and/or some statins can interfere with clopidogrel antiplatelet effect
and result in adverse cardiovascular outcomes in patients treated with coronary artery
stents and dual antiplatelet therapy.
The primary aim of the study is to determine the effect of various currently used PPI on
platelet aggregation in patients undergoing percutaneous coronary intervention (PCI) and
treated with dual antiplatelet therapy.
The secondary aim of the study is to evaluate how statins and 2C19*2 polymorphism modulate
the effect of PPI on clopidogrel efficacy.
Clinical Details
Official title: Evaluation of the Influence of Statins and Proton Pump Inhibitors on Clopidogrel Antiplatelet Effects
Study design: Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Pharmacodynamics Study
Primary outcome: Percent change in residual platelet aggregation by light transmittance aggregometry and percent change in platelet reactivity index by VASP
Secondary outcome: Resistance to clopidogrel by light transmittance aggregometry (defined by RPA >55%), resistance to clopidogrel by vasodilator-stimulated phosphoprotein (VASP) (defined by PRI >55%)Prevalence and role of CYP 2C19*2 polymorphism on the effect of PPIs and statins on the antiplatelet activity of clopidogrel The composite of death from all causes, myocardial infarction, ischemia-driven repeat revascularization, and stroke Need to stop any antiplatelet medication for gastrointestinal bleeding or peptic ulcer disease
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subject must be 18 years of age or older
- Bare metal stent implantation
- Discharged with dual antiplatelet therapy for at least 60 days
- Written informed consent
Exclusion Criteria:
- Patients who do not consent to participate in the study
- Premenopausal women not using contraceptive methods or without a negative pregnancy
test in the past week
- Patients treated or planned to be treated with oral anticoagulants
- Present treatment with or clear indication for treatment with a PPI or H2 antagonists
- Allergy or intolerance to study medications including ranitidine, Proton pump
inhibitors, atorvastatin, rosuvastatin, aspirin and/or clopidogrel
- Patient treated with a strong CYP2C19 interacting drug
- History of a bleeding diathesis, or evidence of active abnormal bleeding within 30
days before enrollment
- History of intracranial hemorrhage or intracranial surgery in the last 3 months
- History of gastro-intestinal ulcers in the last 3 months
- Any serious illness or any condition that the investigator feels would influence the
impact of this therapy on the subject
- Known platelet count < 100000/mm3 at time of enrollment or within 24 hours prior to
enrollment
Locations and Contacts
Ugo Dery, PhD, Phone: 4186568711, Ext: 3383, Email: ugo.dery@criucpq.ulaval.ca
Institut Universitaire de Cardiologie et de Pneumologie de Quebec, Quebec City, Quebec G1V4G5, Canada; Recruiting
Ugo Dery, PhD, Phone: 4186568711, Ext: 3383, Email: ugo.dery@criucpq.ulaval.ca
Guy Rossignol, MSc, Phone: 4186568711, Ext: 5366, Email: guy.rossignol@criucpq.ulaval.ca
Jean-Pierre Dery, MD, MHS, Principal Investigator
Additional Information
Centre de recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Starting date: June 2009
Ending date: April 2011
Last updated: September 14, 2009
|
