Using AtorVASTatin to Prevent VAscular Inflammatory OccLUSion in the Critically Ill

Study Overview
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Brief Summary
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Patients are admitted to the critical care unit of the hospital because of medical conditions that have a high likelihood of causing severe problems with blood flow, breathing, or brain function. These conditions also have a high likelihood of causing death. Approximately 10 to 15% of all critically ill patients die in hospital. A large amount of scientific evidence suggests that a substantial proportion of these deaths is due to a combination of blot clotting and inflammation in the blood vessels. Statins are drugs that interfere with cholesterol and fat metabolism. Cholesterol and fat in the blood are associated with blood clotting and inflammation in the blood vessels. Statins are known to be very beneficial in improving the survival after heart attacks, and in preventing heart attacks. The question that VASTVALUS asks is: do statins improve survival among all critically ill patients? In VASTVALUS, we will concentrate on patients that do not currently require a statin because of their medical condition e.g. after a heart attack, but we are concerned with the rest of the critically ill. In VASTVALUS, participating patients will receive either atorvastatin 80 mg daily or a placebo. Atorvastatin is a statin with a well-established record of safety and effectiveness. A placebo has no known medical activity. We will follow all patients in VASTVALUS to determine whether atorvastatin has any effect on the occurrence of death, stroke, heart attack, or kidney failure among the critically ill. Results from VASTVALUS will be shared with the medical community after the study is completed. As with all clinical trials, patients in VASTVALUS participate of their own choice, and can change their mind at any time.

Official Title
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Using AtorVASTatin to Prevent VAscular Inflammatory OccLUSion in the Critically Ill

Conditions
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Myocardial Infarction, Stroke, Renal Failure

Intervention / Treatment
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* Drug: atorvastatin 80 mg per os daily
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Men or women >18 years of age 2. Admitted to a critical care unit and requiring at least a 48 hour critical care unit stay for medical reasons. Medical reasons include: conditions of cardiovascular, respiratory, or neurologic impairment that require supportive care and observation. Exclusion Criteria: 1. Hepatic failure (Childs-Pugh class C) 2. Rhabdomyolysis 3. Allergy or hypersensitivity to this drug or any of its components 4. Previous intolerance 5. Enrolment in another interventional trial 6. Contraindication to gastric and/or small bowel drug administration 7. MI as major diagnosis at admission (statin indicated) 8. Coronary artery intervention within previous 3 days 9. Currently receiving a statin or indicated (MI, dyslipidemia) 10. Pregnancy 11. personal or family history of hereditary muscular disorders 12. previous history of muscle toxicity with another HMG-CoA reductase Inhibitor 13. concomitant use of a fibrate or niacin 14. hypothyroidism 15. alcohol abuse 16. excessive physical exercise 17. renal impairment 18. diabetes with hepatic fatty change 19. surgery and trauma 20. frailty 21. situations where an increased plasma level of active ingredient may occur

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: atorvastatin 80 mg<br>active treatment | Drug: atorvastatin 80 mg per os daily<br>* atorvastatin 80 mg per os daily<br>|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vascular occlusive events |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| liver enzyme elevation |  | 30 days | 
| rhabdomyolysis |  | 30 days | 
| myalgias |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atorvastatin, vascular occlusion, myocardial infarction, stroke, renal failure, critically ill, Vascular occlusive events among the critically ill