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The Impact of Grapefruit Juice on the Response to Clopidogrel

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT00817999
First received: January 6, 2009
Last updated: August 28, 2012
Last verified: August 2012

January 6, 2009
August 28, 2012
November 2008
July 2011   (final data collection date for primary outcome measure)
% Platelet Inhibition [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
% platelet inhibition measured by Verify Now
Not Provided
Complete list of historical versions of study NCT00817999 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Impact of Grapefruit Juice on the Response to Clopidogrel
The Impact of Grapefruit Juice on the Response to a Loading Dose and Maintenance Dose of Clopidogrel in Healthy Volunteers

This study will measure the percentage of platelet aggregation inhibition with a loading dose of clopidogrel (300 mg) using the VerifyNow Assay System in healthy volunteers who have drank 11 oz of grapefruit juice. It will also measure the percentage of platelet aggregation inhibition with a maintenance dose of clopidogrel (75 mg/day) using the VerifyNow Assay System in healthy volunteers who have drank 11 oz grapefruit juice daily.

This study will examine the effect of GFJ on the loading dose (300 mg) of clopidogrel and will evaluate the effect of GFJ on the maintenance dose (75 mg/day) of clopidogrel. Subjects will be randomized to either initially receive GFJ prior to their loading dose of clopidogrel or receive GFJ prior to their second loading dose. The subjects who have been randomized to receive GFJ initially will drink two small cans (11 oz total) of regular strength GFJ in the morning, followed two hours later by a loading dose (300 mg) of clopidogrel and will then return to the clinic 6 hours after their loading dose to have their platelet inhibition measured. Subjects will have ~ 5 milliliters (1 teaspoonful) of whole blood drawn from an antecubital vein in their forearm via a 21 gauge needle attached to a blue-top plastic vacuette sodium citrate blood collection (Greiner, Monroe, NC) tube to test inhibition of platelet aggregation. After their first loading dose, a 2 week washout period will follow to allow for their platelet aggregation to return to normal. Following the washout period, the subjects will take their second loading dose of clopidogrel and again return to the clinic for platelet inhibition measurement. The same timing will be followed for the loading dose taken without prior GFJ.

During the maintenance dose phase of this study, subjects will take 75 mg/day clopidogrel for 7 days with or without GFJ. Subjects will be randomized to either GFJ during the first period or GFJ during the second period. A minimum 2 week washout period will occur between the two 7 day courses of clopidogrel. Platelet inhibition measurement will occur at the end of each 7 day period as described above.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Screening
Healthy
  • Dietary Supplement: Grapefruit juice
    Participants received grapefruit juice during 1 of the 2 periods.
  • Drug: Clopidogrel 75 mg/day
  • Drug: Clopidogrel 300 mg
  • Experimental: Loading Dose
    Participants received a 300 mg dose of clopidogrel with or without GFJ.
    Interventions:
    • Dietary Supplement: Grapefruit juice
    • Drug: Clopidogrel 300 mg
  • Experimental: Maintenance Dose
    Participants received clopidogrel 75 mg/day for 7 days with or without GFJ
    Interventions:
    • Dietary Supplement: Grapefruit juice
    • Drug: Clopidogrel 75 mg/day
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
July 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ages 19-40
  • Health status confirmed by medical history and physical examination and laboratory analysis

Exclusion Criteria:

  • Pregnancy
  • Taking routine prescription or over-the-counter prescriptions
  • Taken over-the-counter analgesic/anti-inflammatory medication within two weeks of study participation
  • Recently had grapefruit juice or regularly drinks grapefruit juice
Both
19 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00817999
08-15073
Yes
Creighton University
Creighton University
Not Provided
Principal Investigator: Tammy Burns, PharmD Creighton Cardiac Center
Creighton University
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP