Using AtorVASTatin to Prevent VAscular Inflammatory OccLUSion in the Critically Ill "VASTVALUS"

Completed

Phase 2/3 Results N/A

Trial Description

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.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: placebo
    ARM 1: Kind: Experimental
    Label: placebo
  • Atorvastatin 80 mg per os daily Drug
    Intervention Desc: atorvastatin 80 mg per os daily
    ARM 1: Kind: Experimental
    Label: atorvastatin 80 mg
    Description: active treatment

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary vascular occlusive events 30 days No
Secondary liver enzyme elevation 30 days Yes
Secondary rhabdomyolysis 30 days Yes
Secondary myalgias 30 days No

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