Pharmacodynamic Study on Efficacy of Clopidogrel With St. John's Wort

• Status: Withdrawn
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate whether patients post PCI receiving clopidogrel who are carriers of at least one CYP 2C19 loss-of-function allele may achieve improved pharmacodynamic efficacy of clopidogrel when treated with the CYP 2C19 enzyme inducing agent, St. John's wort, as compared with placebo.

Hypothesis

1. Reduced platelet reactivity is present in patients receiving St. John's wort as compared to placebo when utilized in combination with clopidogrel

2. The combination or St. John's wort and clopidogrel results in enhanced platelet inhibition

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lancaster General Hospital
• Collaborators: H G Barsumian MD Memorial Fund; H. G. Barsumian Memorial Fund; Louise von Hess Medical Research Institute
• Treatments: Clopidogrel

Criteria

Inclusion Criteria:

• Patients age 18 or older

• Patients with a history of ACS and/or who receive PCI with stent placement at Lancaster General Hospital requiring dual antiplatelet therapy with aspirin and clopidogrel.

Exclusion Criteria:

• Patients with active or any known history of bleeding such as gastrointestinal, intracranial, or any other bleeding diathesis

• History of major surgery in the last year (any surgical procedure that involves general anesthesia or respiratory assistance)

• Clinical findings associated with an increased risk of bleeding at the judgment of the investigator

• Patients actively receiving anticoagulation therapy

• Hemoglobin < 10 g/dL

• Platelets < 150,000/mm3

• Known hepatic dysfunction

• History of intracranial malignancy or stroke

• Patients receiving thienopyridines chronically prior to PCI

• Concurrent use of CYP P450 2C19 substrates, or inhibiting/ inducing medications with the exception of proton pump inhibitors

• Illicit drug or alcohol abuse

• Daily treatment with nonsteroidal anti-inflammatory drugs or cyclooxygenase-2 inhibitors

• Allergy to St. Johns wort or lactose

• Patients expected to discontinue dual antiplatelet therapy prior to completion of the study protocol

• Patients unable to adhere to the study protocol