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

NCT01175200 | Completed DMC

• 1 other identifier: DOSAPI
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Anti Platelet Effects

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• high on-treatment platelet reactivity Clopidogrel pharmacokinetics responses

  14 days

Study Arms (4)

Prasugrel

ACTIVE COMPARATOR

Drug: Prasugrel

Clopidogrel

ACTIVE COMPARATOR

Drug: Clopidogrel

Lansoprazole

ACTIVE COMPARATOR

proton pump inhibitor

Drug: Lansoprazole

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Clopidogrel DRUG

antiplatelet agent

Clopidogrel

Prasugrel DRUG

antiplatelet agent

Prasugrel

Lansoprazole DRUG

proton pum inhibitor

Also known as: Lanzor, Ogast

Lansoprazole

Placebo DRUG

placebo comparator similar to lansoprazole

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Any formal indication to maintain PPI treatment
• 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.

Sponsors & Collaborators

• Ascopharm Groupe Novasco: lead
• Groupe Hospitalier Pitie-Salpetriere: collaborator
• Medco Health Solutions, Inc.: collaborator

Study Sites (1)

Pitié Salpétrière Hospital

Paris, 75013, France

Location

MeSH Terms

Interventions

Clopidogrel; Prasugrel Hydrochloride; Lansoprazole

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Piperazines; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Benzimidazoles

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2010
• First Posted: August 4, 2010
• Study Start: September 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: July 4, 2012

Record last verified: 2012-07

Locations

FR (1)