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

NCT01330589 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-10-05

No results posted yet for this study

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

Conditions

  • Acute Coronary Syndrome

Interventions

DRUG

Placebo

Non-active placebo for 7 days: PO/TID

DRUG

St. Johns Wort

For 7 days: 300mg PO/TID

Sponsors & Collaborators

  • H G Barsumian MD Memorial Fund

    collaborator OTHER

  • Louise von Hess Medical Research Institute

    collaborator OTHER

  • Lancaster General Hospital

    lead OTHER

Principal Investigators

  • Kathy M Makkar, PharmD · Lancaster General Hospital

  • Roy S Small, MD · Lancaster General Hospital

  • Rupal P Dumasia, MD · Lancaster General Hospital

  • Jill A Rebuck, PharmD · Lancaster General Hospital

  • Michael A Horst, PhD · Lancaster General Research Institute

  • Yee M Lee, PharmD · Lancaster General Hospital

  • Richard D Paoletti, RPh · Lancaster General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01330589 on ClinicalTrials.gov