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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01073800
Recruitment Status : Completed
First Posted : February 23, 2010
Last Update Posted : December 16, 2011
Information provided by (Responsible Party):
University of Alberta

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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Stroke Renal Failure Drug: atorvastatin 80 mg per os daily Drug: placebo Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Using AtorVASTatin to Prevent VAscular Inflammatory OccLUSion in the Critically Ill
Study Start Date : April 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: atorvastatin 80 mg
active treatment
Drug: atorvastatin 80 mg per os daily
atorvastatin 80 mg per os daily

Placebo Comparator: placebo Drug: placebo

Primary Outcome Measures :
  1. vascular occlusive events [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. liver enzyme elevation [ Time Frame: 30 days ]
  2. rhabdomyolysis [ Time Frame: 30 days ]
  3. myalgias [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01073800

Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta

Responsible Party: University of Alberta Identifier: NCT01073800     History of Changes
Other Study ID Numbers: VASTVALUS
First Posted: February 23, 2010    Key Record Dates
Last Update Posted: December 16, 2011
Last Verified: December 2011

Keywords provided by University of Alberta:
vascular occlusion
myocardial infarction
renal failure
critically ill
Vascular occlusive events among the critically ill

Additional relevant MeSH terms:
Myocardial Infarction
Critical Illness
Renal Insufficiency
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Disease Attributes
Kidney Diseases
Urologic Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors