Double the Dose of Clopidogrel or Switch to Prasugrel to Antagonize Proton Pump Inhibitor Interaction.
Summary
This study will establish the optimal therapeutic strategy for patients with a coronary artery disease (CAD) and chronically treated with clopidogrel 75 mg/day requiring co-administration of an anti-platelet treatment with P2Y12 antagonist and a PPI for treatment/prevention of GI ulceration.
Study Design
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Anti Platelet Effects
Intervention
Clopidogrel, Prasugrel, Lansoprazole, Placebo
Location
Pitié Salpétrière Hospital
Paris
France
75013
Status
Completed
Source
Ascopharm Groupe Novasco
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01175200
- Information obtained from ClinicalTrials.gov on July 31, 2012
Medical and Biotech [MESH] Definitions
Anti-inflammatory Agents, Non-steroidal
Anti-inflammatory agents that are not steroids. In addition to anti-inflammatory actions, they have analgesic, antipyretic, and platelet-inhibitory actions. They are used primarily in the treatment of chronic arthritic conditions and certain soft tissue disorders associated with pain and inflammation. They act by blocking the synthesis of prostaglandins by inhibiting cyclooxygenase, which converts arachidonic acid to cyclic endoperoxides, precursors of prostaglandins. Inhibition of prostaglandin synthesis accounts for their analgesic, antipyretic, and platelet-inhibitory actions; other mechanisms may contribute to their anti-inflammatory effects. Certain NSAIDs also may inhibit lipoxygenase enzymes or TYPE C PHOSPHOLIPASES or may modulate T-cell function. (AMA Drug Evaluations Annual, 1994, p 1814-5)
Gray Platelet Syndrome
A rare, inherited platelet disorder characterized by a selective deficiency in the number and contents of platelet alpha-granules. It is associated with THROMBOCYTOPENIA, enlarged platelets, and prolonged bleeding time.
Bepridil
A long-acting calcium-blocking agent with significant anti-anginal activity. The drug produces significant coronary vasodilation and modest peripheral effects. It has antihypertensive and selective anti-arrhythmia activities and acts as a calmodulin antagonist.
Antigens, Human Platelet
Human alloantigens expressed only on platelets, specifically on platelet membrane glycoproteins. These platelet-specific antigens are immunogenic and can result in pathological reactions to transfusion therapy.
Platelet Membrane Glycoprotein Iib
Platelet membrane glycoprotein IIb is an integrin alpha subunit that heterodimerizes with INTEGRIN BETA3 to form PLATELET GLYCOPROTEIN GPIIB-IIIA COMPLEX. It is synthesized as a single polypeptide chain which is then postranslationally cleaved and processed into two disulfide-linked subunits of approximately 18 and 110 kDa in size.
Clinical Trials
A Study of Acute Coronary Syndrome Patients
This study will evaluate the use of a prasugrel 60 mg loading dose administered during percutaneous coronary intervention (PCI) with and without a prior loading dose (LD)of clopidogrel on...
This study will compare the effect of a prasugrel 10-mg maintenance dose with a clopidogrel 75-mg maintenance dose on platelet activity, approximately 1 week after the first dose of study...
Prasugrel/Clopidogrel Maintenance Dose Washout Study
The primary objective of the study is to describe the cumulative proportion of subjects who return to baseline platelet P2Y12 receptor function over time (up to 12 days post last maintenan...
Plavix, Prasugrel and Drug Eluting Stents Pilot Trial
- The purpose of this study is to determine the level of inhibition of platelet activation of an approved thienopyridine(clopidogrel or prasugrel) and aspirin regimen in the...
Prasugrel Versus Double Dose Clopidogrel to Treat Clopidogrel Low-responsiveness After PCI
All patients undergoing elective or sub-acute PCI are screened by MULTIPLATE test for clopidogrel low-responsiveness after receiving 600 mg clopidogrel the day before. A cut off value has...
PubMed Articles
The interaction between proton pump inhibitors (PPIs) and clopidogrel/prasugrel were investigated. The IC(50) values of omeprazole, esomeprazole, lansoprazole, pantoprazole, and rabeprazole on the met...
OBJECTIVES: The objective was to evaluate the pharmacodynamic response of switching patients on maintenance phase clopidogrel therapy after an acute coronary syndrome (ACS) to prasugrel. BACKGROUND: P...
Platelet inhibition with prasugrel.
Platelet activation plays a pivotal role in the pathogenesis of coronary artery disease. The long-term benefit of dual anti-platelet therapy with clopidogrel and aspirin is well established for patien...
Background: High on clopidogrel treatment platelet reactivity (HTPR) is frequent in patients on hemodialysis (HD). Objectives: The primary aim of the study was to determine the antiplatelet effect...
This study sought to investigate the efficacy, safety, and antiplatelet effect of prasugrel as compared with clopidogrel in patients with high on-treatment platelet reactivity (HTPR) after elective pe...
