Using AtorVASTatin to Prevent VAscular Inflammatory OccLUSion in the Critically Ill

NCT ID: NCT01073800

Last Updated: 2011-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2011-09-30

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.

Conditions

Myocardial Infarction; Stroke; Renal Failure

Keywords

atorvastatin; vascular occlusion; myocardial infarction; stroke; renal failure; critically ill; Vascular occlusive events among the critically ill

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

atorvastatin 80 mg

active treatment

Group Type: ACTIVE_COMPARATOR

atorvastatin 80 mg per os daily

Intervention Type: DRUG

atorvastatin 80 mg per os daily

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo

Interventions

atorvastatin 80 mg per os daily

atorvastatin 80 mg per os daily

Intervention Type: DRUG

placebo

placebo

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Alberta

Edmonton, Alberta, Canada

Countries

Canada

Other Identifiers

VASTVALUS

Identifier Type: -

Identifier Source: org_study_id