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Clopidogrel Pharmacogenomics Project

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ClinicalTrials.gov Identifier: NCT01097343
Recruitment Status : Completed
First Posted : April 1, 2010
Results First Posted : March 26, 2014
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Disease Susceptibility
Interventions Drug: clopidogrel 75 mg
Drug: Clopidogrel 150 mg
Enrollment 50
Recruitment Details 50 patients with 2C19*2 polymorphism were recruited to participate in a cross-over study comparing 75 vs. 150 mg of clopidogrel. 25 patients were randomized to start with 75 mg, and 25 patients started with 150 mg for 30 day dosing periods.
Pre-assignment Details Cross-over study with two 30-day dosing periods. All patients were receiving chronic clopidogrel prior to enrollment after percutaneous coronary intervention.
Arm/Group Title 75 mg First 30 Days, Followed by 150 mg 150 mg First 30 Days, Followed by 75 mg
Hide Arm/Group Description 25 patients with the target allele were identified, and receive 75mg followed by 150 mg clopidogrel daily for two separate dosing periods of 30 days 25 patients with the target allele were identified, and received 150 mg clopidogrel followed by 75 mg clopidogrel for two daily for separate dosing periods of 30 days
Period Title: First Intervention- 30 Days
Started 25 25
Completed 25 25
Not Completed 0 0
Period Title: Second Intervention- 30 Days
Started 25 25
Completed 25 25
Not Completed 0 0
Arm/Group Title Cross-over Study
Hide Arm/Group Description All Study Participants
Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
<=18 years
0
   0.0%
Between 18 and 65 years
27
  54.0%
>=65 years
23
  46.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants
62.8  (13.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
15
  30.0%
Male
35
  70.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants
50
1.Primary Outcome
Title Clopidogrel Resistance, Defined by P2Y12 Reaction Units (PRU)Value >230
Hide Description P2Y12 Reaction Units are measured using the VerifyNow P2Y12 assay. Percent of patients with clopidogrel resistance defined by PRU value will be compared among low and high dose clopidogrel groups after 30 days of therapy.
Time Frame Approximately 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
All patients completed the clinical protocol.
Arm/Group Title Cross-over Study- 75 mg Dose Cross-over Study - 150 mg Dose
Hide Arm/Group Description:
Participants received standard dose clopidogrel (75 mg) and higher dose (150 mg) for 30 days
Participants received standard dose clopidogrel (75 mg) and higher dose (150 mg) for 30 days
Overall Number of Participants Analyzed 50 50
Measure Type: Number
Unit of Measure: Number of Patients with PRU>230
30 18
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cross-over Study- 75 mg Dose, Cross-over Study - 150 mg Dose
Comments A sample of size of 50 patients for the cross-over study was chosen because it provided 80% power to detect a decrease in the rate of high on-clopidogrel platelet reactivity (HPR, defined as >230 PRU) from 75% to 46% with high dose clopidogrel, with a two-sided alpha of 0.05
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.02
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame Adverse event data was collected for 90 days after enrollment in the dosing study.
Adverse Event Reporting Description Adverse event data was collected during patient visits and with a follow-up phone call 30 days after completion of the dosing protocol.
 
Arm/Group Title 75 mg Followed by 150 mg 150 mg Followed by 75 mg
Hide Arm/Group Description Cross-over study Cross-over study
All-Cause Mortality
75 mg Followed by 150 mg 150 mg Followed by 75 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
75 mg Followed by 150 mg 150 mg Followed by 75 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/25 (4.00%)      0/25 (0.00%)    
Gastrointestinal disorders     
Major Bleeding * [1]  1/25 (4.00%)  1 0/25 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
GI bleeding requiring blood transfusion- this event occurred in a patient receiving the 150mg dose
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
75 mg Followed by 150 mg 150 mg Followed by 75 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      0/25 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Joseph S. Rossi
Organization: St. Vincent Medical Group
Phone: 765 482 0656
EMail: jrossi@thecaregroup.com
Layout table for additonal information
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01097343     History of Changes
Other Study ID Numbers: 09-2104
First Submitted: March 30, 2010
First Posted: April 1, 2010
Results First Submitted: July 9, 2012
Results First Posted: March 26, 2014
Last Update Posted: December 12, 2017