Double the Dose of Clopidogrel or Switch to Prasugrel to Antagonize Proton Pump Inhibitor Interaction. (DOSAPI)

Double the Dose of Clopidogrel or Switch to Prasugrel to Antagonize Proton Pump Inhibitor Interaction. A Prospective, Mono-center, Placebo- and Active Treatment-controlled, Randomized, Cross Over Study.

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 Overview

• Status: Completed
• Conditions: Anti Platelet Effects
• Intervention / Treatment: Drug: Prasugrel; Drug: Clopidogrel; Drug: Lansoprazole; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Pitié Salpêtrière hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria :

• patient with stable Coronary Artery Disease (< 3 months) treated with clopidogrel (75mg/d)
• Between 18 and 75 years of age
• Body Mass Index between 18 and 30 kg/m2 and body weight not less than 60 kg
• No major bleeding according to ISTH definition
• Subjects who signed an informed consent document
• Subjects who signed a separate pharmacogenomic informed consent document
• Subjects registered to the French national welfare system

Exclusion Criteria:

• Personal or family history of coagulation or bleeding disorders
• Use of known inhibitors or inducers of CYP2C19 and CYP3A including grape fruit juice intake
• Known hypersensitivity to lansoprazole, its excipients, or substituted benzimidazoles,
• Known hypersensitivity to clopidogrel / prasugrel
• Anti-platelet treatment other than clopidogrel + aspirin within 7 days before inclusion
• Any formal indication to maintain PPI treatment
• PPI within 15 days before inclusion in the study
• Active pathology with 10 days before inclusion
• Prior history of stent thrombosis
• Prior history of Stroke
• Employee of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; placebo comparator similar to lansoprazole
ACTIVE_COMPARATOR: Prasugrel	Drug: Prasugrel; antiplatelet agent
ACTIVE_COMPARATOR: Clopidogrel	Drug: Clopidogrel; antiplatelet agent
ACTIVE_COMPARATOR: Lansoprazole; proton pump inhibitor	Drug: Lansoprazole; proton pum inhibitor; Other Names: Lanzor; Ogast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in antiplatelet effect of clopidogrel	change in antiplatetelet effect of clopidogrel as compared to prasugrel when associated to lansoprazole (or placebo) in patients with stable angina	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
high on-treatment platelet reactivity Clopidogrel pharmacokinetics responses	compare persistant antiplatelet hyper reactivity in patients with stable angina and treated with clopidogrel or prasugrel associated with lansoprazole (or placebo)	14 days

Collaborators and Investigators

• Sponsor: Ascopharm Groupe Novasco
• Collaborators: Groupe Hospitalier Pitie-Salpetriere; Medco Health Solutions, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (ACTUAL): July 1, 2012
• Study Completion (ACTUAL): July 1, 2012

Study Registration Dates

• First Submitted: August 3, 2010
• First Submitted That Met QC Criteria: August 3, 2010
• First Posted (ESTIMATE): August 4, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): July 4, 2012
• Last Update Submitted That Met QC Criteria: July 3, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Clopidogrel; Dexlansoprazole; Lansoprazole; Prasugrel Hydrochloride
• Other Study ID Numbers: DOSAPI