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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Stroke; Renal Failure
• Intervention / Treatment: Drug: placebo; Drug: atorvastatin 80 mg per os daily

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: placebo; placebo
Active Comparator: atorvastatin 80 mg; active treatment	Drug: atorvastatin 80 mg per os daily; atorvastatin 80 mg per os daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
vascular occlusive events	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
liver enzyme elevation	30 days
rhabdomyolysis	30 days
myalgias	30 days

Collaborators and Investigators

• Sponsor: University of Alberta

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: July 20, 2009
• First Submitted That Met QC Criteria: February 22, 2010
• First Posted (Estimate): February 23, 2010

Study Record Updates

• Last Update Posted (Estimate): December 16, 2011
• Last Update Submitted That Met QC Criteria: December 15, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: stroke; myocardial infarction; critically ill; renal failure; atorvastatin; vascular occlusion; Vascular occlusive events among the critically ill
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Disease Attributes; Myocardial Infarction; Infarction; Renal Insufficiency; Critical Illness; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: VASTVALUS