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

Not Applicable

Completed

• Conditions: Anti Platelet Effects
• Interventions: Drug: Prasugrel; Drug: Clopidogrel; Drug: Lansoprazole; Drug: Placebo

• Registration Number: NCT01175200
• Lead Sponsor: Ascopharm Groupe Novasco

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-03
• Study First Submitted QC: 2010-08-03
• Study First Posted: 2010-08-04
• Study Start: 2010-09
• Status Verified: 2012-07
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Last Update Submitted: 2012-07-03
• Last Update Posted: 2012-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prasugrel	Prasugrel	-
Clopidogrel	Clopidogrel	-
Lansoprazole	Lansoprazole	proton pump inhibitor
Placebo	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pitié Salpétrière Hospital; 🇫🇷 Paris, France