Pharmacodynamic Study on Efficacy of Clopidogrel With St. John's Wort
Withdrawn before enrolling · Not applicable · Has a placebo group
Conditions studied: Acute Coronary Syndrome
In brief
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
Key facts
- Study ID
- NCT01330589
- Run by
- Lancaster General Hospital
- People needed
- 0
- Starts
- 2011-04-01
- Expected to finish
- 2015-03-01
- Last updated by the study team
- 2017-10-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Lancaster General Hospital — Lancaster, Pennsylvania, United States
Full record on ClinicalTrials.gov
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