Trial Outcomes & Findings for Study of Atorvastatin Versus Placebo to Reduce Cardiopulmonary Complications After Thoracic Surgery (NCT NCT00375518)

NCT ID: NCT00375518

Last Updated: 2021-01-06

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 162 participants
• Primary outcome timeframe: one week (minimum of 5 days) before surgery and continued for one week (minimum of 5 days) after surgery
• Results posted on: 2021-01-06

Participant Flow

Participant milestones

Measure	Atorvastatin 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: 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 Study STARTED	80	82
Overall Study COMPLETED	72	65
Overall Study NOT COMPLETED	8	17

Reasons for withdrawal

Measure	Atorvastatin 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: 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 Study Withdrawal by Subject	2	10
Overall Study Patient Not Treated	6	6
Overall Study Death	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Atorvastatin n=80 Participants 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 n=82 Participants 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 n=162 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=5 Participants	46 Participants n=7 Participants	83 Participants n=5 Participants
Age, Categorical >=65 years	43 Participants n=5 Participants	36 Participants n=7 Participants	79 Participants n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	33 Participants n=7 Participants	69 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants	49 Participants n=7 Participants	93 Participants n=5 Participants

PRIMARY outcome

Timeframe: one week (minimum of 5 days) before surgery and continued for one week (minimum of 5 days) after surgery

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.

Outcome measures

Measure	Atorvastatin n=72 Participants 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 n=65 Participants 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.
Determine the Postoperative Complications Found in Each Group With Post Operative Complications	16 participants	8 participants
Determine the Postoperative Complications Found in Each Group Without Post Operative Complications	56 participants	57 participants

Adverse Events

Atorvastatin

Serious events: 1 serious events

Other events: 31 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Measure	Atorvastatin n=80 participants at risk 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 n=82 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Adult Respiratory Distress Synd (ARDS)	1.2% 1/80 • Number of events 1	1.2% 1/82 • Number of events 1

Other adverse events

Measure	Atorvastatin n=80 participants at risk 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 n=82 participants at risk 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.
Metabolism and nutrition disorders Glucose, high (hyperglycemia)	8.8% 7/80 • Number of events 7	6.1% 5/82 • Number of events 5
Blood and lymphatic system disorders Hemoglobin	6.2% 5/80 • Number of events 5	7.3% 6/82 • Number of events 6
Blood and lymphatic system disorders Lymphopenia	18.8% 15/80 • Number of events 15	20.7% 17/82 • Number of events 17
Metabolism and nutrition disorders Phosphate, low (hypophosphatemia)	15.0% 12/80 • Number of events 12	24.4% 20/82 • Number of events 20
Metabolism and nutrition disorders Sodium, low (hyponatremia)	6.2% 5/80 • Number of events 5	0.00% 0/82

Additional Information

Dr. David Amar

Memorial Sloan Kettering Cancer Center

Phone: 212-639-6798

Email: amard@mskcc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place