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

This study has been completed.
Sponsor:
Collaborators:
Groupe Hospitalier Pitie-Salpetriere
Medco Health Solutions, Inc.
Information provided by (Responsible Party):
Ascopharm Groupe Novasco
ClinicalTrials.gov Identifier:
NCT01175200
First received: August 3, 2010
Last updated: July 3, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Anti Platelet Effects
Drug: Clopidogrel
Drug: Prasugrel
Drug: Lansoprazole
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Ascopharm Groupe Novasco:

Primary Outcome Measures:
  • Change in antiplatelet effect of clopidogrel [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    change in antiplatetelet effect of clopidogrel as compared to prasugrel when associated to lansoprazole (or placebo) in patients with stable angina


Secondary Outcome Measures:
  • high on-treatment platelet reactivity Clopidogrel pharmacokinetics responses [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    compare persistant antiplatelet hyper reactivity in patients with stable angina and treated with clopidogrel or prasugrel associated with lansoprazole (or placebo)


Enrollment: 82
Study Start Date: September 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prasugrel Drug: Prasugrel
antiplatelet agent
Active Comparator: Clopidogrel Drug: Clopidogrel
antiplatelet agent
Active Comparator: Lansoprazole
proton pump inhibitor
Drug: Lansoprazole
proton pum inhibitor
Other Names:
  • Lanzor
  • Ogast
Placebo Comparator: Placebo Drug: Placebo
placebo comparator similar to lansoprazole

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01175200

Locations
France
Pitié Salpétrière Hospital
Paris, France, 75013
Sponsors and Collaborators
Ascopharm Groupe Novasco
Groupe Hospitalier Pitie-Salpetriere
Medco Health Solutions, Inc.
  More Information

No publications provided

Responsible Party: Ascopharm Groupe Novasco
ClinicalTrials.gov Identifier: NCT01175200     History of Changes
Other Study ID Numbers: DOSAPI
Study First Received: August 3, 2010
Last Updated: July 3, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Lansoprazole
Dexlansoprazole
Proton Pump Inhibitors
Clopidogrel
Prasugrel
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Hematologic Agents
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014