Trial | NCT01175200  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    82
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 Started
Sep 30
2010
Primary Completion
Jul 31
2012
Study Completion
Jul 31
2012
Last Update
Jul 04
2012
Estimate

Drug Clopidogrel

antiplatelet agent

Drug Prasugrel

antiplatelet agent

Drug Lansoprazole

proton pum inhibitor

  • Other names: Lanzor, Ogast

Drug Placebo

placebo comparator similar to lansoprazole

Prasugrel Active Comparator

Clopidogrel Active Comparator

Lansoprazole Active Comparator

proton pump inhibitor

Placebo Placebo Comparator

Criteria 

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.
No Results Posted