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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01175200

Acronym

DOSAPI

Enrollment

Registered

2010-08-04

Start date

2010-09-30

Completion date

2012-07-31

Last updated

2012-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anti Platelet Effects

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.

Interventions

DRUGClopidogrel

antiplatelet agent

DRUGPrasugrel

antiplatelet agent

DRUGLansoprazole

proton pum inhibitor

DRUGPlacebo

placebo comparator similar to lansoprazole

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026