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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

Tracking Information
First Submitted Date  ICMJE February 2, 2010
First Posted Date  ICMJE February 3, 2010
Results First Submitted Date  ICMJE January 29, 2015
Results First Posted Date  ICMJE March 26, 2015
Last Update Posted Date January 2, 2018
Study Start Date  ICMJE March 2010
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2015)
Rates of COPD Exacerbations [ Time Frame: up to 37 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 2, 2010)
Frequency, severity and rates of COPD exacerbations [ Time Frame: up to 37 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2017)
  • Time to First COPD Exacerbation [ Time Frame: up to 37 months ]
  • Change in FEV1 (% Pred) From Baseline to Last Measure [ Time Frame: Baseline, last measure at up to 37 months ]
  • Acute Exacerbation COPD Hospitalization Rates (Events/Patient Year) [ Time Frame: up to 37 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2010)
  • Time to first COPD exacerbation [ Time Frame: up to 37 months ]
  • Lung function, dyspnea, and quality of life [ Time Frame: up to 37 months ]
  • Hospitalization rates and healthcare utilization [ Time Frame: up to 37 months ]
  • Systemic and lung-specific biomarkers of inflammation and procoagulant activity [ Time Frame: up to 37 months ]
  • Cost-effectiveness of simvastatin therapy for COPD [ Time Frame: up to 37 months ]
  • Rate of combined cardiovascular events [ Time Frame: up to 37 months ]
  • The effect of current smoking status on inflammatory biomarker levels and response to simvastatin treatment [ Time Frame: up to 37 months ]
  • Pharmacogenetics and pharmacoepigenetics of statin therapy in COPD [ Time Frame: one time point within study period ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Simvastatin Therapy for Moderate and Severe COPD
Official Title  ICMJE Prospective Randomized Placebo-Controlled Trial of SimvaSTATin in the Prevention of COPD Exacerbations (STATCOPE)
Brief Summary To determine the effect of daily administration of 40 mgms simvastatin taken for at least 12 months (range 12-36 months) on the frequency of exacerbations of chronic obstructive lung disease (COPD) in patients with moderate to severe COPD who are prone to exacerbations and do not have other indications for statin treatment.
Detailed Description COPD exacerbation is a common complication that significantly contributes to the high morbidity, mortality and costs associated with COPD. COPD exacerbations are associated with heightened lung inflammation that may have systemic implications (e.g., peripheral muscle weakness, cognitive impairment, depression, stroke, acute coronary syndrome, and atherosclerosis). Statins are potent agents that significantly reduce vascular events in patients with increased risks due to prior cardiac or cerebral vascular events and elevated lipid profiles. Statins have pleiotropic effects that extend well beyond their lipid lowering effects and may be potent anti-inflammatory agents. Retrospective data conducted in COPD patients indicate that statin use is associated with markedly decreased rates of COPD hospitalization and stabilization of lung function. Decreases in mortality in COPD due to complications of flu-like illnesses and deaths due to cardiovascular events have also been reported. Inflammatory biomarkers (C-reactive protein and interleukin- 6) are reported to be elevated in moderate to severe COPD patients who are prone to exacerbations. Inflammatory biomarkers (C-reactive protein and interleukin- 6) are reported to be reduced by statin therapy in patients with hyperlipidemia and cardiovascular diseases. Treatments that can effectively lessen the prevalence and severity of COPD exacerbations are desperately needed
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Disease, Chronic Obstructive
Intervention  ICMJE
  • Drug: simvastatin
    40 mgms of simvastatin daily
    Other Name: Zocor
  • Drug: Placebo
    Matched placebo pill daily
    Other Name: sugar pill
Study Arms  ICMJE
  • Active Comparator: simvastatin
    40 mgms of simvastatin daily
    Intervention: Drug: simvastatin
  • Placebo Comparator: placebo
    Matched placebo pill daily
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 13, 2014)
885
Original Estimated Enrollment  ICMJE
 (submitted: February 2, 2010)
1126
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male and female subjects, 40-80 years of age.
  2. Clinical diagnosis of at least moderate COPD as defined by the GOLD criteria:

    1. Postbronchodilator FEV1(forced expiratory volume at one second)/FVC(forced vital capacity) < 70%,
    2. Postbronchodilator FEV1 (forced expiratory volume at one second) < 80% predicted, with or without chronic symptoms (i.e., cough, sputum production).
  3. Cigarette consumption of 10 pack-years or more. Patients may or may not be active smokers.
  4. Must meet one or more of the following 4 conditions

    1. Be using supplemental oxygenate
    2. Receiving a course of systemic corticosteroids and/or antibiotics for respiratory problems in the past year,
    3. Visiting an Emergency Department for a COPD exacerbation within the past year, or
    4. Being hospitalized for a COPD (Chronic Obstructive Pulmonary Disease) exacerbation within the past year
  5. Willingness to make return visits and availability by telephone for duration of study.
  6. Free of active coronary disease
  7. Subject with expected life expectancy > 36 months

Exclusion Criteria:

  1. Patients who:

    1. are on statin drugs.
    2. should be on statins based on established risk stratification using the ATP-III (Adult Treatment Panel) to determine 10 year risk.
  2. Documented history of active coronary heart disease, such as unstable angina, prior myocardial infarction, stroke, symptomatic peripheral vascular or carotid artery disease, or congestive heart failure within the past 3 months.
  3. A diagnosis of asthma.
  4. The presence of a diagnosis other than COPD that results in the patient being either medically unstable, or having a predicted life expectancy < 3 years.
  5. Special patient groups: prisoners, pregnant women, institutionalized patients
  6. Women who are at risk of becoming pregnant during the study (pre-menopausal) and who refuse to use acceptable birth control (hormone-based oral or barrier contraceptive) for the duration of the study.
  7. Woman using estradiol compounds for contraception. Postmenopausal women on estradiol compounds for hormone replacement therapy will be allowed into the trial.
  8. Participants otherwise meeting the inclusion criteria will not be enrolled until they are a minimum of four weeks from their most recent acute exacerbation.
  9. A clinical diagnosis of bronchiectasis defined as production of > one-half cup of purulent sputum/day.
  10. Participants using niacin, azole antifungals (itraconazole, ketoconazole, posaconazole), fibric acid derivatives, erythromycin, clarithromycin, telithromycin, diltiazem, amlodipine , ranolazine,HIV protease inhibitors (such as indinavir), amiodarone, gemfibrozil, cyclosporine, verapamil, danazol, nefazodone, and red yeast rice extracts are excluded
  11. Active liver disease. Active liver disease is defined as ALT (alanine aminotransferase), AST (aspartate aminotransferase) as greater than 1.5 times the upper limit of normal.
  12. Patients with renal failure defined by serum creatinine greater than 3mg/dl.
  13. Alcoholism. Alcoholism is defined as > 35 drinks per week. A drink is defined as one bottle of beer, one 8-ounce glass of wine, or one ounce of hard liquor.
  14. Hypersensitivity to HMG CoA (3-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitors. Hypersensitivity is defined as an allergic reaction to statin, prior history of myopathy, rhabdomyolysis or previous intolerance to statin use.
  15. Participants drinking greater than 4 cups (1qt) of grapefruit juice per day.
  16. Participants drinking greater than 3 cups of green tea per day.
  17. Diabetics will be excluded. Diabetics are defined by:

1. A CURRENT physician diagnosis of diabetes OR 2. CURRENT use of diabetic meds OR 3. Elevated HbA1c > 6.5% 18. The discretion of the Principal Investigator that the potential participant will not be a reliable study subject to complete the study requirements.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01061671
Other Study ID Numbers  ICMJE 689
U10HL074424 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of Minnesota
Original Responsible Party John E. Connett, PhD (Principal Investigator of Coordinating Center), University of Minnesota, COPD Clinical Research Network Coordinating Center
Current Study Sponsor  ICMJE University of Minnesota
Original Study Sponsor  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Collaborators  ICMJE
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Canadian Institutes of Health Research (CIHR)
  • Ottawa Hospital Research Institute
Investigators  ICMJE
Principal Investigator: John E Connett, PhD University of Minnesota (Data Coordinating Center)
Principal Investigator: Steven M Scharf, MD, PhD University of Maryland, Baltimore
Principal Investigator: Mark Dransfield, MD University of Alabama at Birmingham
Principal Investigator: George Washko, MD Brigham and Women's Hospital Boston
Principal Investigator: Richard K Albert, MD Denver Health Medical Center
Principal Investigator: Richard Casaburi, MD, PhD Harbor-UCLA Research & Education Institute
Principal Investigator: Dennis E Niewoehner, MD Minnesota Veterans Affairs Medical Center
Principal Investigator: Gerard J Criner, MD Temple University Philadelphia
Principal Investigator: Frank Sciurba, MD University of Pittsburgh
Principal Investigator: Stephen C Lazarus, MD University of California at San Francisco
Principal Investigator: Fernando J Martinez, MD University of Michigan
Principal Investigator: Don Sin, M.D. St. Paul's Hospital
Principal Investigator: Shawn Aaron, M.D. The Ottawa Hospital
PRS Account University of Minnesota
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP