Lowering the Risk of Operative Complications Using Atorvastatin Loading Dose

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients submitted to noncardiac surgeries are at increased risk of serious cardiovascular complications. Statins have shown to lower cholesterol levels and reduce cardiovascular events in other scenarios. The objective of this study is to explore the effects of atorvastatin, as compared with placebo, on the 30-day risk of a composite of death, nonfatal Myocardial Injury after Noncardiac Surgery (MINS), or stroke among patients who undergo noncardiac surgery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital do Coracao
• Treatments: Atorvastatin; Atorvastatin Calcium

Criteria

Inclusion Criteria:

Patients older than 40 years-old undergoing non-cardiac surgery with an expected hospital stay of at least 24hs and that fulfills any one of the following criteria:

A) Established vascular disease:

i) Major vascular surgery ii) All types of surgery in patients with overt atherosclerosis (any significant or symptomatic coronary, cerebral or peripheral artery disease)

B) Without established vascular disease:

At least 3 risk factors for cardiovascular complications:

1. Major surgery;

2. Emergency surgery;

3. Previous history of heart failure;

4. diabetes;

5. Arterial hypertension;

6. Smoking habit along the last two years;

7. chronic kidney disease (creatinine greater than 2mg/dl);

8. Patients older than 70 years.

Exclusion Criteria:

• Previous intolerance to statins

• Current rhabdomyolysis

• Current use of statins

• Severe Liver Failure (CHILD-PUGH SCORE C)

• Breast-feeding or pregnancy

• Low-risk surgeries