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The Impact of Grapefruit Juice on the Response to Clopidogrel

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ClinicalTrials.gov Identifier: NCT00817999
Recruitment Status : Completed
First Posted : January 7, 2009
Results First Posted : October 1, 2012
Last Update Posted : October 1, 2012
Sponsor:
Information provided by (Responsible Party):
Creighton University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Screening
Condition Healthy
Interventions Dietary Supplement: Grapefruit juice
Drug: Clopidogrel 75 mg/day
Drug: Clopidogrel 300 mg
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Loading Dose Maintenance Dose
Hide Arm/Group Description Healthy volunteers who received a 300 mg dose of clopidogrel with or without grapefruit juice. Healthy volunteers who received clopidogrel 75 mg/day for 7 days during each period with or without grapefruit juice.
Period Title: Grapefruit Juice
Started 15 17
Completed 15 17
Not Completed 0 0
Period Title: No Grapefruit Juice
Started 15 17
Completed 15 17
Not Completed 0 0
Arm/Group Title Loading Dose Maintenance Dose Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 15 17 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 17 participants 32 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
 100.0%
17
 100.0%
32
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 17 participants 32 participants
24.4  (5.9) 25.47  (5.66) 25.47  (5.66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 17 participants 32 participants
Female
10
  66.7%
13
  76.5%
23
  71.9%
Male
5
  33.3%
4
  23.5%
9
  28.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 17 participants 32 participants
15 17 32
1.Primary Outcome
Title % Platelet Inhibition
Hide Description % platelet inhibition measured by Verify Now
Time Frame 6 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Loading Dose With Grapefruit Juice Maintenance Dose With Grapefruit Juice Loading Dose Without Grapefruit Juice Maintenance Dose Without Grapefruit Juice
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 15 17 15 17
Mean (Standard Deviation)
Unit of Measure: percentage of platelet inhibition
23.4  (14.2) 24.6  (24.2) 41.2  (19.1) 59  (22.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Loading Dose Maintenance Dose
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Loading Dose Maintenance Dose
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Loading Dose Maintenance Dose
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Loading Dose Maintenance Dose
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/17 (0.00%) 
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Tammy Burns, PharmD
Organization: Creighton University
Phone: 402-280-4292
Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT00817999     History of Changes
Other Study ID Numbers: 08-15073
First Submitted: January 6, 2009
First Posted: January 7, 2009
Results First Submitted: August 8, 2011
Results First Posted: October 1, 2012
Last Update Posted: October 1, 2012