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

Sponsor

University of Alberta (Other)

Overall Status

Completed

CT.gov ID

NCT01073800

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Anticipated 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 :

Apr 1, 2009

Actual Primary Completion Date :

Aug 1, 2009

Actual Study Completion Date :

Sep 1, 2011

Arms and Interventions

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 placebo

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

placebo

Outcome Measures

Primary Outcome Measures

vascular occlusive events [30 days]

Secondary Outcome Measures

liver enzyme elevation [30 days]
rhabdomyolysis [30 days]
myalgias [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1. Men or women >18 years of age
1. 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.