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Genetically Guided Statin Therapy

This study has been completed.
Sponsor:
Collaborator:
David Grant U.S. Air Force Medical Center
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01894230
First received: July 3, 2013
Last updated: June 21, 2017
Last verified: June 2017
Results First Received: April 24, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Hypercholesterolemia
Hydroxy-methylglutaryl-coenzyme A (HMG Co-A) Reductase Inhibitors Adverse Reaction
Interventions: Genetic: SLCO1B1*5 allele testing, results reported at randomization
Genetic: SLCO1B1*5 allele testing, results reported at end of study
Genetic: Genetic testing for SLCO1B1*5 allele

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Eight participants that signed a consent either withdrew consent, were lost-to follow up, or were screen-failures and thus were not randomized.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Genotype Results Plus Usual Care
  • Genetic testing for SLCO1B1*5 allele
  • Reporting for SLCO1B1*5 allele at randomization

Reporting for SLCO1B1*5 allele at randomization: Reporting of genetic test results to patient and provider at randomization

Genetic testing for SLCO1B1*5 allele: Blood test for SLCO1B1*5 allele

Usual Care Only
  • Genetic testing for SLCO1B1*5 allele
  • Reporting for SLCO1B1*5 allele at the end of study

Reporting for SLCO1B1*5 allele at the end: Usual care recommendations provided to patient and provider at randomization. Genotyping results provided at the end of study.

Genetic testing for SLCO1B1*5 allele: Blood test for SLCO1B1*5 allele


Participant Flow:   Overall Study
    Genotype Results Plus Usual Care   Usual Care Only
STARTED   83   76 
COMPLETED   76   69 
NOT COMPLETED   7   7 
Lost to Follow-up                2                2 
Withdrawal by Subject                4                4 
Non-adherent                0                1 
Death                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Genotype Results Plus Usual Care
  • Genetic testing for SLCO1B1*5 allele
  • Reporting for SLCO1B1*5 allele at randomization

Reporting for SLCO1B1*5 allele at randomization: Reporting of genetic test results to patient and provider at randomization

Genetic testing for SLCO1B1*5 allele: Blood test for SLCO1B1*5 allele

Usual Care Only
  • Genetic testing for SLCO1B1*5 allele
  • Reporting for SLCO1B1*5 allele at the end of study

Reporting for SLCO1B1*5 allele at the end: Usual care recommendations provided to patient and provider at randomization. Genotyping results provided at the end of study.

Genetic testing for SLCO1B1*5 allele: Blood test for SLCO1B1*5 allele

Total Total of all reporting groups

Baseline Measures
   Genotype Results Plus Usual Care   Usual Care Only   Total 
Overall Participants Analyzed 
[Units: Participants]
 83   76   159 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.7  (10.2)   62.5  (11.5)   62.6  (10.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      41  49.4%      50  65.8%      91  57.2% 
Male      42  50.6%      26  34.2%      68  42.8% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Race/Ethnicity       
White      66  79.5%      61  80.3%      127  79.9% 
Black/African American      14  16.9%      11  14.5%      25  15.7% 
Other      3   3.6%      4   5.3%      7   4.4% 
Region of Enrollment 
[Units: Participants]
     
United States   83   76   159 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Morisky Medication Adherence Scale (MMAS) Score   [ Time Frame: 3 months and 8 months ]

2.  Secondary:   Low Density Lipoprotein Cholesterol (LDLc) at Baseline, Month 3 and Month 8   [ Time Frame: Baseline, Month 3, Month 8 ]

3.  Secondary:   Medication Possession Ratio (MPR) From Baseline to Last Patient Follow-up   [ Time Frame: Baseline to Last patient follow-up in study (3 months or 8 months) ]

4.  Secondary:   Number of Participants Reporting New Statin Prescriptions   [ Time Frame: Baseline, Month 3, Month 8 ]

5.  Secondary:   Brief Pain Inventory (BPI) Score - Pain Severity at Month 3 and Month 8   [ Time Frame: Month 3 and Month 8 ]

6.  Secondary:   Brief Pain Inventory (BPI) Score - Pain Interference at Month 3 and Month 8   [ Time Frame: Month 3 and Month 8 ]

7.  Secondary:   Change in Short Form -12 Item (SF-12) Health Survey - Physical Component (PC)   [ Time Frame: Baseline, Month 3, Month 8 ]

8.  Secondary:   Change in Short Form -12 Item (SF-12) Health Survey - Mental Component (MC)   [ Time Frame: Baseline, Month 3, Month 8 ]

9.  Secondary:   Physical Activity Scale Score   [ Time Frame: Baseline and Month 8 ]

10.  Secondary:   Beliefs About Medications (BMQ) Score at Baseline, Month 3 and Month 8   [ Time Frame: Baseline, Month 3, Month 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Deepak Voora
Organization: Duke University
phone: 919-668-1755
e-mail: Deepak.vorra@duke.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01894230     History of Changes
Other Study ID Numbers: Pro00044989
Pro00045542 ( Other Identifier: DUHS IRB )
Study First Received: July 3, 2013
Results First Received: April 24, 2017
Last Updated: June 21, 2017