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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
NCT01073800
First received: July 20, 2009
Last updated: December 15, 2011
Last verified: December 2011
  Purpose

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 Intervention Phase
Myocardial Infarction
Stroke
Renal Failure
Drug: atorvastatin 80 mg per os daily
Drug: placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Using AtorVASTatin to Prevent VAscular Inflammatory OccLUSion in the Critically Ill

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • vascular occlusive events [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • liver enzyme elevation [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • rhabdomyolysis [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • myalgias [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2009
Study Completion Date: September 2011
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01073800

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

No publications provided

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT01073800     History of Changes
Other Study ID Numbers: VASTVALUS
Study First Received: July 20, 2009
Last Updated: December 15, 2011
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on October 22, 2014