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Study of Atorvastatin Versus Placebo to Reduce Cardiopulmonary Complications After Thoracic Surgery

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ClinicalTrials.gov Identifier: NCT00375518
Recruitment Status : Completed
First Posted : September 13, 2006
Results First Posted : January 22, 2016
Last Update Posted : January 6, 2021
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Thoracic Surgery
Interventions Drug: Atorvastatin
Drug: Placebo
Enrollment 162
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Atorvastatin Placebo
Hide Arm/Group Description Atorvastatin: Atorvastatin 40 mg once a day beginning 7 days before the operation. Surgical procedures will be as planned and unaffected by this study. Starting from the day after surgery, patients will be given their study drug for an additional 7 days. Placebo: Placebo given beginning 7 days before the operation. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
Period Title: Overall Study
Started 80 82
Completed 72 65
Not Completed 8 17
Reason Not Completed
Withdrawal by Subject             2             10
Patient Not Treated             6             6
Death             0             1
Arm/Group Title Atorvastatin Placebo Total
Hide Arm/Group Description Atorvastatin: Atorvastatin 40 mg once a day beginning 7 days before the operation. Surgical procedures will be as planned and unaffected by this study. Starting from the day after surgery, patients will be given their study drug for an additional 7 days. Placebo: Placebo given beginning 7 days before the operation. Starting from the day after surgery, patients will be given their study drug for an additional 7 days. Total of all reporting groups
Overall Number of Baseline Participants 80 82 162
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 82 participants 162 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
37
  46.3%
46
  56.1%
83
  51.2%
>=65 years
43
  53.8%
36
  43.9%
79
  48.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 82 participants 162 participants
Female
36
  45.0%
33
  40.2%
69
  42.6%
Male
44
  55.0%
49
  59.8%
93
  57.4%
1.Primary Outcome
Title Determine the Postoperative Complications Found in Each Group
Hide Description To determine whether one week of preventive therapy with atorvastatin prior to surgery and one week after surgery reduced the composite rate of cardiovascular morbidity when compared to placebo.
Time Frame one week (minimum of 5 days) before surgery and continued for one week (minimum of 5 days) after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atorvastatin Placebo
Hide Arm/Group Description:
Atorvastatin: Atorvastatin 40 mg once a day beginning 7 days before the operation. Surgical procedures will be as planned and unaffected by this study. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
Placebo: Placebo given beginning 7 days before the operation. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
Overall Number of Participants Analyzed 72 65
Measure Type: Number
Unit of Measure: participants
With Post Operative Complications 16 8
Without Post Operative Complications 56 57
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Atorvastatin Placebo
Hide Arm/Group Description Atorvastatin: Atorvastatin 40 mg once a day beginning 7 days before the operation. Surgical procedures will be as planned and unaffected by this study. Starting from the day after surgery, patients will be given their study drug for an additional 7 days. Placebo: Placebo given beginning 7 days before the operation. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
All-Cause Mortality
Atorvastatin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Atorvastatin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/80 (1.25%)      1/82 (1.22%)    
Respiratory, thoracic and mediastinal disorders     
Adult Respiratory Distress Synd (ARDS)  1  1/80 (1.25%)  1 1/82 (1.22%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-3.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Atorvastatin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/80 (38.75%)      33/82 (40.24%)    
Blood and lymphatic system disorders     
Hemoglobin  1  5/80 (6.25%)  5 6/82 (7.32%)  6
Lymphopenia  1  15/80 (18.75%)  15 17/82 (20.73%)  17
Metabolism and nutrition disorders     
Glucose, high (hyperglycemia)  1  7/80 (8.75%)  7 5/82 (6.10%)  5
Phosphate, low (hypophosphatemia)  1  12/80 (15.00%)  12 20/82 (24.39%)  20
Sodium, low (hyponatremia)  1  5/80 (6.25%)  5 0/82 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-3.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. David Amar
Organization: Memorial Sloan Kettering Cancer Center
Phone: 212-639-6798
EMail: amard@mskcc.org
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00375518    
Other Study ID Numbers: 06-079
First Submitted: September 11, 2006
First Posted: September 13, 2006
Results First Submitted: December 16, 2015
Results First Posted: January 22, 2016
Last Update Posted: January 6, 2021