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

Ascopharm Groupe Novasco

Status: Completed

Conditions: Anti Platelet Effects

Treatments: Drug: Clopidogrel; Drug: Lansoprazole; Drug: Prasugrel; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01175200

DOSAPI

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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82 participants in 4 patient groups, including a placebo group

Prasugrel

Active Comparator group

Treatment:

Drug: Prasugrel

Clopidogrel

Active Comparator group

Treatment:

Drug: Clopidogrel

Lansoprazole

Active Comparator group

Description:

proton pump inhibitor

Treatment:

Drug: Lansoprazole

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo