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Simvastatin Therapy for Moderate and Severe COPD (STATCOPE)

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ClinicalTrials.gov Identifier: NCT01061671
Recruitment Status : Terminated (Futility)
First Posted : February 3, 2010
Results First Posted : March 26, 2015
Last Update Posted : January 2, 2018
Sponsor:
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

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
Enrollment 885

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Simvastatin Placebo
Hide Arm/Group Description

40 mgms of simvastatin daily

Simvastatin: 40 mgms of simvastatin daily

Matched placebo pill daily

Placebo: Matched placebo pill daily

Period Title: Overall Study
Started 433 452
Completed 386 397
Not Completed 47 55
Reason Not Completed
Withdrawal by Subject             16             20
Lost to Follow-up             3             5
Death             28             30
Arm/Group Title Simvastatin Placebo Total
Hide Arm/Group Description

40 mgms of simvastatin daily

Simvastatin: 40 mgms of simvastatin daily

Matched placebo pill daily

Placebo: Matched placebo pill daily

Total of all reporting groups
Overall Number of Baseline Participants 433 452 885
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 433 participants 452 participants 885 participants
62.2  (8.5) 62.3  (8.4) 62.2  (8.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 433 participants 452 participants 885 participants
Female
184
  42.5%
203
  44.9%
387
  43.7%
Male
249
  57.5%
249
  55.1%
498
  56.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 433 participants 452 participants 885 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 433 participants 452 participants 885 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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 433 participants 452 participants 885 participants
United States 362 376 738
Canada 71 76 147
Smoking History (Pack Years)  
Mean (Standard Deviation)
Unit of measure:  Pack Years
Number Analyzed 433 participants 452 participants 885 participants
50.0  (26.1) 51.2  (28.7) 50.6  (27.4)
Post‐bronchodilator FEV1 (forced expiratory volume at one second)  
Mean (Standard Deviation)
Unit of measure:  Liters (L)
Number Analyzed 433 participants 452 participants 885 participants
1.19  (0.58) 1.19  (0.56) 1.19  (0.57)
FEV1/FVC (forced expiratory volume at one second/forced vital capacity)  
Mean (Standard Deviation)
Unit of measure:  Ratio
Number Analyzed 433 participants 452 participants 885 participants
0.44  (0.13) 0.44  (0.13) 0.44  (0.13)
FEV1 (% Predicted)  
Mean (Standard Deviation)
Unit of measure:  Percent predicted
Number Analyzed 433 participants 452 participants 885 participants
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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 433 participants 452 participants 885 participants
Yes 216 238 454
No 217 214 431
[1]
Measure Description: 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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 433 participants 452 participants 885 participants
Yes 367 382 749
No 66 70 136
Use of supplemental oxygen within previous 12 mo  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 433 participants 452 participants 885 participants
Yes 198 222 420
No 235 230 465
1.Primary Outcome
Title Rates of COPD Exacerbations
Hide Description [Not Specified]
Time Frame up to 37 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis excludes participants without any follow-up data.
Arm/Group Title Simvastatin Placebo
Hide Arm/Group Description:

40 mgms of simvastatin daily

Simvastatin: 40 mgms of simvastatin daily

Matched placebo pill daily

Placebo: Matched placebo pill daily

Overall Number of Participants Analyzed 430 447
Mean (Standard Deviation)
Unit of Measure: exacerbations/person-year
1.36  (1.61) 1.39  (1.73)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simvastatin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments [Not Specified]
Method negative binomial regression
Comments Adjustments of confidence intervals for between-participant variation (overdispersion).
2.Secondary Outcome
Title Time to First COPD Exacerbation
Hide Description [Not Specified]
Time Frame up to 37 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis excludes participants without any follow-up data.
Arm/Group Title Simvastatin Placebo
Hide Arm/Group Description:

40 mgms of simvastatin daily

Simvastatin: 40 mgms of simvastatin daily

Matched placebo pill daily

Placebo: Matched placebo pill daily

Overall Number of Participants Analyzed 430 447
Median (95% Confidence Interval)
Unit of Measure: Days to the first exacerbation
223
(195 to 275)
231
(193 to 303)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simvastatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.34
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
3.Secondary Outcome
Title Change in FEV1 (% Pred) From Baseline to Last Measure
Hide Description [Not Specified]
Time Frame Baseline, last measure at up to 37 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis excludes participants without any follow-up data.
Arm/Group Title Simvastatin Placebo
Hide Arm/Group Description:

40 mgms of simvastatin daily

Simvastatin: 40 mgms of simvastatin daily

Matched placebo pill daily

Placebo: Matched placebo pill daily

Overall Number of Participants Analyzed 356 356
Median (90% Confidence Interval)
Unit of Measure: percent predicted
-0.86
(-11.04 to 8.67)
-1.81
(-10.62 to 7.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simvastatin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .1461
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Acute Exacerbation COPD Hospitalization Rates (Events/Patient Year)
Hide Description [Not Specified]
Time Frame up to 37 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis excludes participants without any follow-up data.
Arm/Group Title Simvastatin Placebo
Hide Arm/Group Description:

40 mgms of simvastatin daily

Simvastatin: 40 mgms of simvastatin daily

Matched placebo pill daily

Placebo: Matched placebo pill daily

Overall Number of Participants Analyzed 430 447
Mean (95% Confidence Interval)
Unit of Measure: events per patient year
0.31
(0.24 to 0.38)
0.31
(0.23 to 0.38)
Time Frame Up to 37 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Simvastatin Placebo
Hide Arm/Group Description

40 mgms of simvastatin daily

Simvastatin: 40 mgms of simvastatin daily

Matched placebo pill daily

Placebo: Matched placebo pill daily

All-Cause Mortality
Simvastatin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Simvastatin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   178/433 (41.11%)      190/452 (42.04%)    
Blood and lymphatic system disorders     
Cavernous Hemangioma  1  0/433 (0.00%)  0 1/452 (0.22%)  2
Cardiac disorders     
Rheumatic Heart Disease  1  1/433 (0.23%)  1 0/452 (0.00%)  0
Ischemic Heart Disease  1  4/433 (0.92%)  4 6/452 (1.33%)  6
Pulmonary Circulation disorders  1  4/433 (0.92%)  5 6/452 (1.33%)  6
Pericarditis  1  1/433 (0.23%)  1 0/452 (0.00%)  0
Cardiomyopathy  1  2/433 (0.46%)  2 0/452 (0.00%)  0
Cardiac Dysrhythmias  1  7/433 (1.62%)  7 4/452 (0.88%)  5
Heart Failure  1  4/433 (0.92%)  6 5/452 (1.11%)  7
Tachycardia  1  1/433 (0.23%)  1 0/452 (0.00%)  0
Eye disorders     
Orbital cellulitis  1  0/433 (0.00%)  0 1/452 (0.22%)  1
Gastrointestinal disorders     
Esophagus and stomach disorders  1  1/433 (0.23%)  1 5/452 (1.11%)  5
Appendicitis  1  1/433 (0.23%)  1 0/452 (0.00%)  0
Abdominal Hernia  1  2/433 (0.46%)  2 2/452 (0.44%)  2
Enteritis  1  3/433 (0.69%)  3 0/452 (0.00%)  0
Other Intestinal disorders  1  7/433 (1.62%)  9 5/452 (1.11%)  5
Other Digestive Disorders  1  11/433 (2.54%)  14 7/452 (1.55%)  8
Nissen Fundoplication  1  0/433 (0.00%)  0 1/452 (0.22%)  1
Ill defined digestive symptoms  1  1/433 (0.23%)  1 2/452 (0.44%)  2
General disorders     
Syncope  1  5/433 (1.15%)  5 1/452 (0.22%)  1
Dizziness  1  2/433 (0.46%)  2 0/452 (0.00%)  0
Severe Headaches  1  1/433 (0.23%)  1 0/452 (0.00%)  0
Ill defined abdominal pain  1  2/433 (0.46%)  2 3/452 (0.66%)  4
Sudden death of unknown cause  1  4/433 (0.92%)  4 4/452 (0.88%)  4
Complications of surgical and medical care  1  4/433 (0.92%)  4 2/452 (0.44%)  2
Respiratory Arrest  1  2/433 (0.46%)  2 1/452 (0.22%)  1
Abnormal Gait  1  1/433 (0.23%)  1 0/452 (0.00%)  0
Epistaxis  1  1/433 (0.23%)  1 0/452 (0.00%)  0
Sepsis  1  1/433 (0.23%)  1 4/452 (0.88%)  4
Fatigue  1  0/433 (0.00%)  0 1/452 (0.22%)  1
Infections and infestations     
Bacterial Infection  1  0/433 (0.00%)  0 1/452 (0.22%)  1
Viral Infection  1  1/433 (0.23%)  1 0/452 (0.00%)  0
Other Infection  1 [1]  0/433 (0.00%)  0 1/452 (0.22%)  1
Injury, poisoning and procedural complications     
Fractures  1  7/433 (1.62%)  7 4/452 (0.88%)  4
Sprain  1  1/433 (0.23%)  1 1/452 (0.22%)  1
Intracranial injury  1  1/433 (0.23%)  1 0/452 (0.00%)  0
Internal Injury  1  1/433 (0.23%)  2 1/452 (0.22%)  1
Contusion  1  1/433 (0.23%)  1 0/452 (0.00%)  0
Trauma from motorcycle accident  1  1/433 (0.23%)  1 0/452 (0.00%)  0
Poisoning  1  1/433 (0.23%)  1 1/452 (0.22%)  1
Concussion  1  0/433 (0.00%)  0 1/452 (0.22%)  1
Metabolism and nutrition disorders     
Metabolic disorders  1  5/433 (1.15%)  6 5/452 (1.11%)  5
Musculoskeletal and connective tissue disorders     
Arthropathy  1  1/433 (0.23%)  1 5/452 (1.11%)  6
Dorsopathy  1  4/433 (0.92%)  4 3/452 (0.66%)  3
Rheumatism  1  3/433 (0.69%)  3 1/452 (0.22%)  1
Osteopathy  1  2/433 (0.46%)  2 1/452 (0.22%)  1
Spondylolisthesis  1  1/433 (0.23%)  1 0/452 (0.00%)  0
Degenerative Disc Disease  1  1/433 (0.23%)  1 0/452 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon Cancer  1  0/433 (0.00%)  0 1/452 (0.22%)  1
Liver Cancer  1  0/433 (0.00%)  0 1/452 (0.22%)  2
Respiratory Cancer  1  9/433 (2.08%)  12 10/452 (2.21%)  14
Bone Neoplasm  1  1/433 (0.23%)  1 4/452 (0.88%)  4
Genitourinary Neoplasm  1  4/433 (0.92%)  5 5/452 (1.11%)  7
Squamous Cell Carcinoma  1  0/433 (0.00%)  0 1/452 (0.22%)  1
Lymphatic Neoplasm  1  0/433 (0.00%)  0 1/452 (0.22%)  1
Neuroendocrine Neoplasm  1  1/433 (0.23%)  1 1/452 (0.22%)  1
Nervous system disorders     
Central Nervous System disorders  1  1/433 (0.23%)  1 0/452 (0.00%)  0
Pain  1  0/433 (0.00%)  0 2/452 (0.44%)  2
Seizure  1  0/433 (0.00%)  0 1/452 (0.22%)  1
Psychiatric disorders     
Mental Disorder  1  3/433 (0.69%)  4 5/452 (1.11%)  6
Altered Mental Status  1  0/433 (0.00%)  0 1/452 (0.22%)  1
Renal and urinary disorders     
Nephrotic disorders  1  2/433 (0.46%)  2 0/452 (0.00%)  0
Other Urinary Disorder  1  5/433 (1.15%)  5 5/452 (1.11%)  5
Disorders of the Male Genitourinary System  1  0/433 (0.00%)  0 2/452 (0.44%)  3
Disorders of the Female Genitourinary System  1  1/433 (0.23%)  1 1/452 (0.22%)  1
Respiratory, thoracic and mediastinal disorders     
Acute Respiratory Infection  1  1/433 (0.23%)  3 1/452 (0.22%)  1
Pneumonia  1  34/433 (7.85%)  40 27/452 (5.97%)  32
Influenza  1  5/433 (1.15%)  5 6/452 (1.33%)  9
Bronchitis  1  0/433 (0.00%)  0 1/452 (0.22%)  2
Emphysema  1  3/433 (0.69%)  3 1/452 (0.22%)  1
Pneumoconioses  1  0/433 (0.00%)  0 1/452 (0.22%)  1
COPD Exacerbation  1  96/433 (22.17%)  155 97/452 (21.46%)  187
COPD other  1  9/433 (2.08%)  9 10/452 (2.21%)  15
Other Respiratory  1  12/433 (2.77%)  14 13/452 (2.88%)  20
Ill Defined Respiratory events  1  10/433 (2.31%)  11 13/452 (2.88%)  15
Hypoxemia  1  0/433 (0.00%)  0 2/452 (0.44%)  2
Skin and subcutaneous tissue disorders     
Skin Infection  1  2/433 (0.46%)  2 3/452 (0.66%)  4
Cellulitis  1  1/433 (0.23%)  1 0/452 (0.00%)  0
Vascular disorders     
Cerebrovascular  1  1/433 (0.23%)  1 6/452 (1.33%)  6
Artery disorder  1  2/433 (0.46%)  2 2/452 (0.44%)  3
Vein disorder  1  4/433 (0.92%)  4 3/452 (0.66%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, ICD-9
[1]
Pulmonary Aspergillosis
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Simvastatin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   316/433 (72.98%)      329/452 (72.79%)    
General disorders     
Headache  1  16/433 (3.70%)  20 23/452 (5.09%)  27
Musculoskeletal and connective tissue disorders     
Arthropathies  1  25/433 (5.77%)  38 32/452 (7.08%)  43
Dorsopathies  1  27/433 (6.24%)  35 27/452 (5.97%)  32
Rheumatism  1  67/433 (15.47%)  89 54/452 (11.95%)  73
Renal and urinary disorders     
Urinary Infection  1  26/433 (6.00%)  56 23/452 (5.09%)  30
Respiratory, thoracic and mediastinal disorders     
Acute Respiratory Infection  1  109/433 (25.17%)  159 107/452 (23.67%)  166
Pneumonia  1  22/433 (5.08%)  25 17/452 (3.76%)  19
COPD Exacerbation  1  232/433 (53.58%)  642 244/452 (53.98%)  649
Other COPD Related Symptoms  1  41/433 (9.47%)  79 43/452 (9.51%)  80
Dyspnea  1  65/433 (15.01%)  94 59/452 (13.05%)  90
Indicates events were collected by systematic assessment
1
Term from vocabulary, ICD-9
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.
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
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: January 2, 2018