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Clinical Trials/NCT01073800
NCT01073800
Completed
Phase 2

Using AtorVASTatin to Prevent VAscular Inflammatory OccLUSion in the Critically Ill

University of Alberta1 site in 1 country100 target enrollmentApril 2009

Overview

Phase
Phase 2
Intervention
atorvastatin 80 mg per os daily
Conditions
Myocardial Infarction
Sponsor
University of Alberta
Enrollment
100
Locations
1
Primary Endpoint
vascular occlusive events
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 2009
End Date
September 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Men or women \>18 years of age
  • 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

  • Hepatic failure (Childs-Pugh class C)
  • Rhabdomyolysis
  • Allergy or hypersensitivity to this drug or any of its components
  • Previous intolerance
  • Enrolment in another interventional trial
  • Contraindication to gastric and/or small bowel drug administration
  • MI as major diagnosis at admission (statin indicated)
  • Coronary artery intervention within previous 3 days
  • Currently receiving a statin or indicated (MI, dyslipidemia)
  • personal or family history of hereditary muscular disorders

Arms & Interventions

atorvastatin 80 mg

active treatment

Intervention: atorvastatin 80 mg per os daily

placebo

Intervention: placebo

Outcomes

Primary Outcomes

vascular occlusive events

Time Frame: 30 days

Secondary Outcomes

  • liver enzyme elevation(30 days)
  • rhabdomyolysis(30 days)
  • myalgias(30 days)

Study Sites (1)

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