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Trial record 1 of 1 for:    STATCOPE
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Simvastatin Therapy for Moderate and Severe COPD (STATCOPE)

This study has been terminated.
(Futility)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01061671
First Posted: February 3, 2010
Last Update Posted: October 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Canadian Institutes of Health Research (CIHR)
Ottawa Hospital Research Institute
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
Results First Submitted: January 29, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Pulmonary Disease, Chronic Obstructive
Interventions: Drug: simvastatin
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Simvastatin

40 mgms of simvastatin daily

Simvastatin: 40 mgms of simvastatin daily

Placebo

Matched placebo pill daily

Placebo: Matched placebo pill daily


Participant Flow:   Overall Study
    Simvastatin   Placebo
STARTED   433   452 
COMPLETED   386   397 
NOT COMPLETED   47   55 
Withdrawal by Subject                16                20 
Lost to Follow-up                3                5 
Death                28                30 



  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
Simvastatin

40 mgms of simvastatin daily

Simvastatin: 40 mgms of simvastatin daily

Placebo

Matched placebo pill daily

Placebo: Matched placebo pill daily

Total Total of all reporting groups

Baseline Measures
   Simvastatin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 433   452   885 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.2  (8.5)   62.3  (8.4)   62.2  (8.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      184  42.5%      203  44.9%      387  43.7% 
Male      249  57.5%      249  55.1%      498  56.3% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      4   0.9%      7   1.5%      11   1.2% 
Not Hispanic or Latino      429  99.1%      445  98.5%      874  98.8% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      2   0.5%      3   0.7%      5   0.6% 
Asian      2   0.5%      0   0.0%      2   0.2% 
Native Hawaiian or Other Pacific Islander      0   0.0%      1   0.2%      1   0.1% 
Black or African American      99  22.9%      91  20.1%      190  21.5% 
White      328  75.8%      346  76.5%      674  76.2% 
More than one race      2   0.5%      11   2.4%      13   1.5% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   362   376   738 
Canada   71   76   147 
Smoking History (Pack Years) 
[Units: Pack Years]
Mean (Standard Deviation)
 50.0  (26.1)   51.2  (28.7)   50.6  (27.4) 
Post‐bronchodilator FEV1 (forced expiratory volume at one second) 
[Units: Liters (L)]
Mean (Standard Deviation)
 1.19  (0.58)   1.19  (0.56)   1.19  (0.57) 
FEV1/FVC (forced expiratory volume at one second/forced vital capacity) 
[Units: Ratio]
Mean (Standard Deviation)
 0.44  (0.13)   0.44  (0.13)   0.44  (0.13) 
FEV1 (% Predicted) 
[Units: Percent predicted]
Mean (Standard Deviation)
 41.5  (17.8)   41.6  (17.6)   41.6  (17.7) 
Acute COPD Exacerbation requiring Hospitalization or ED visit within previous 12 mo [1] 
[Units: Participants]
     
Yes   216   238   454 
No   217   214   431 
[1] Acute COPD (Chronic Obstructive Pulmonary Disease) Exacerbation requiring Hospitalization or Emergency Department visit within previous 12 months
Systemic glucocorticoid or antibiotic use within previous 12 mo 
[Units: Participants]
     
Yes   367   382   749 
No   66   70   136 
Use of supplemental oxygen within previous 12 mo 
[Units: Participants]
     
Yes   198   222   420 
No   235   230   465 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Rates of COPD Exacerbations   [ Time Frame: up to 37 months ]

2.  Secondary:   Time to First COPD Exacerbation   [ Time Frame: up to 37 months ]

3.  Secondary:   Change in FEV1 (% Pred) From Baseline to Last Measure   [ Time Frame: Baseline, last measure at up to 37 months ]

4.  Secondary:   Acute Exacerbation COPD Hospitalization Rates (Events/Patient Year)   [ Time Frame: up to 37 months ]

5.  Secondary:   Systemic and Lung-specific Biomarkers of Inflammation and Procoagulant Activity   [ Time Frame: up to 37 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Rate of Combined Cardiovascular Events   [ Time Frame: up to 37 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   The Effect of Current Smoking Status on Inflammatory Biomarker Levels and Response to Simvastatin Treatment   [ Time Frame: up to 37 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Secondary:   Pharmacogenetics and Pharmacoepigenetics of Statin Therapy in COPD   [ Time Frame: one time point within study period ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Early termination by the Data and Safety Monitoring Board due to futility in respect to a treatment effect. The original study population goal was 1200 and the study was terminated at 885 participants.


  More Information
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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:  
Name/Title: Sarah Lindberg
Organization: University of Minnesota
phone: 612-626-9011
e-mail: sharnden@ccbr.umn.edu


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

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01061671     History of Changes
Other Study ID Numbers: 689
U10HL074424 ( U.S. NIH Grant/Contract )
First Submitted: February 2, 2010
First Posted: February 3, 2010
Results First Submitted: January 29, 2015
Results First Posted: March 26, 2015
Last Update Posted: October 11, 2017