Skip to main content
OpenTrials
Completed

NCT Number: NCT01073800

Using AtorVASTatin to Prevent VAscular Inflammatory OccLUSion in the Critically Ill

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Myocardial Infarction Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Critical Illness Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Infarction Ischemia Kidney Diseases Male Urogenital Diseases Myocardial Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Failure Renal Insufficiency Stroke Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

atorvastatin 80 mg per os daily

Drug

atorvastatin 80 mg per os daily

Placebo

Drug

placebo

Primary outcomes

  1. vascular occlusive events

    Time frame: 30 days

Secondary outcomes

  1. liver enzyme elevation

    Time frame: 30 days

  2. rhabdomyolysis

    Time frame: 30 days

  3. myalgias

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Acronym: VASTVALUS

Important dates

Study start
2009
Primary completion
2009
Study completion
2011
First posted
Feb 23, 2010
Registry last updated
Dec 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.