Pilot Study on the Effect of High Clopidogrel Maintenance Dosing

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Scripps pilot study on the effect of high clopidogrel maintenance dosing and its relationship to cytochrome P450 2C19 polymorphism status [STSI/CTSA].

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Scripps Health
• Collaborator: National Center for Research Resources (NCRR)
• Treatments: Clopidogrel; Ticlopidine

Criteria

Inclusion Criteria:

• Males and non-pregnant females between the ages of 18-85.

• Patients able to give informed written consent.

• Patients on clopidogrel for ≥ 7 days.

Exclusion Criteria:

• Participation in a study of experimental therapy or device within prior 30 days.

• Pregnant women or women of childbearing potential not using an acceptable method of contraception who have not been proven to have a negative pregnancy test result.

• Inability to comply with all aspects of the protocol.

• History of bleeding diathesis or evidence of active abnormal bleeding within previous 90 days.

• Severe hypertension (systolic blood pressure > 200 mm Hg or diastolic blood pressure > 110 mm Hg) not adequately controlled on antihypertensive therapy.

• Major surgery within the preceding 6 weeks.

• History of stroke within 30 days or any history of hemorrhagic stroke.

• History of intracranial neoplasm.

• Current or planned administration of another parenteral GP IIb-IIIa inhibitor within 7 days of enrollment.

• Known hypersensitivity to any component of the product.

• Unstable angina with dynamic ST or T wave changes within 48 hours of enrollment.

• Administration of LMWH within 8 hours prior to enrollment or UFH within 60 minutes unless a PPT < 50 secs or ACT < 150 secs.

• On chronic anticoagulation (i.e. Coumadin).

• Hemoglobin < 10 g/dL.

• Hematocrit < 30%.

• Platelet count < 100,000 mcL.