Using AtorVASTatin to Prevent VAscular Inflammatory OccLUSion in the Critically Ill

NCT01073800 | Completed Phase 2 DMC

• 1 other identifier: VASTVALUS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• vascular occlusive events

  30 days

Secondary Outcomes (3)

• liver enzyme elevation

  30 days

• rhabdomyolysis

  30 days

• myalgias

  30 days

Study Arms (2)

atorvastatin 80 mg

ACTIVE COMPARATOR

active treatment

Drug: atorvastatin 80 mg per os daily

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

atorvastatin 80 mg per os daily DRUG

atorvastatin 80 mg per os daily

atorvastatin 80 mg

placebo DRUG

placebo

placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Men or women \>18 years of age
• \. 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.

You may not qualify if:

• \. Hepatic failure (Childs-Pugh class C)
• \. Rhabdomyolysis
• \. Allergy or hypersensitivity to this drug or any of its components
• \. Previous intolerance
• \. Enrolment in another interventional trial
• \. Contraindication to gastric and/or small bowel drug administration
• \. MI as major diagnosis at admission (statin indicated)
• \. Coronary artery intervention within previous 3 days
• \. Currently receiving a statin or indicated (MI, dyslipidemia)
• \. Pregnancy
• \. personal or family history of hereditary muscular disorders
• \. previous history of muscle toxicity with another HMG-CoA reductase Inhibitor
• \. concomitant use of a fibrate or niacin
• \. hypothyroidism
• \. alcohol abuse

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

MeSH Terms

Conditions

Myocardial Infarction; Stroke; Renal Insufficiency; Critical Illness

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2009
• First Posted: February 23, 2010
• Study Start: April 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: September 1, 2011
• Last Updated: December 16, 2011

Record last verified: 2011-12

Locations

CA (1)