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
  Purpose

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.


Condition Intervention Phase
Healthy
Dietary Supplement: Grapefruit juice
Drug: Clopidogrel 75 mg/day
Drug: Clopidogrel 300 mg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: The Impact of Grapefruit Juice on the Response to a Loading Dose and Maintenance Dose of Clopidogrel in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Creighton University:

Primary Outcome Measures:
  • % Platelet Inhibition [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    % platelet inhibition measured by Verify Now


Enrollment: 32
Study Start Date: November 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Loading Dose
Participants received a 300 mg dose of clopidogrel with or without GFJ.
Dietary Supplement: Grapefruit juice
Participants received grapefruit juice during 1 of the 2 periods.
Drug: Clopidogrel 300 mg
Experimental: Maintenance Dose
Participants received clopidogrel 75 mg/day for 7 days with or without GFJ
Dietary Supplement: Grapefruit juice
Participants received grapefruit juice during 1 of the 2 periods.
Drug: Clopidogrel 75 mg/day

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   19 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00817999

Locations
United States, Nebraska
Creighton Cardiac Center
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Investigators
Principal Investigator: Tammy Burns, PharmD Creighton Cardiac Center
  More Information

No publications provided

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT00817999     History of Changes
Other Study ID Numbers: 08-15073
Study First Received: January 6, 2009
Results First Received: August 8, 2011
Last Updated: August 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Creighton University:
Platelet Aggregation Inhibition

Additional relevant MeSH terms:
Clopidogrel
Ticlopidine
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 26, 2014