Myocardial InfarctionPhase 2/3VASTVALUSNCT01073800
Using AtorVASTatin to Prevent VAscular Inflammatory OccLUSion in the Critically Ill
A Phase 2/3 study testing atorvastatin 80 mg per os daily in people with Myocardial Infarction and Stroke, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Myocardial Infarction, Stroke, Renal Failure
- What is being tested?
- atorvastatin 80 mg per os daily
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2009to Sep 2011
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- atorvastatin 80 mg per os daily, placebo
- Keywords
- atorvastatin, vascular occlusion, myocardial infarction, stroke, renal failure, critically ill, Vascular occlusive events among the critically ill
- Medical subject headings
- Myocardial Infarction, Stroke, Renal Insufficiency, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atorvastatin 80 mg per os dailyDrug
atorvastatin 80 mg per os daily
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| atorvastatin 80 mg | Active comparator | active treatment Receives: Drug: atorvastatin 80 mg per os daily |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
vascular occlusive events
Measured: 30 days
Secondary outcomes (3)
liver enzyme elevation
Measured: 30 days
rhabdomyolysis
Measured: 30 days
myalgias
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startApr 2009
- Primary completionAug 2009
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073800
- Sponsor's protocol ID
- VASTVALUS
- Acronym
- VASTVALUS
- Status last verified
- Dec 2011
- First submitted
- 20 Jul 2009
- Last updated
- 16 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using AtorVASTatin to Prevent VAscular Inflammatory OccLUSion in the Critically Ill
- ClinicalTrials.gov ID
- NCT01073800
- Acronym / sponsor ID
- VASTVALUS / VASTVALUS
- Conditions
- Myocardial Infarction, Stroke, Renal Failure
- Keywords
- atorvastatin, vascular occlusion, myocardial infarction, stroke, renal failure, critically ill, Vascular occlusive events among the critically ill
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 23 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| atorvastatin 80 mg | Active comparator | Drug: atorvastatin 80 mg per os dailyactive treatment |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| atorvastatin 80 mg per os dailyatorvastatin 80 mg per os daily | Drug | atorvastatin 80 mg |
| placeboplacebo | Drug | placebo |
Primary outcome
vascular occlusive events
Time frame: 30 days
3 secondary outcomes
liver enzyme elevation
Time frame: 30 days
rhabdomyolysis
Time frame: 30 days
myalgias
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing atorvastatin 80 mg per os daily in people with Myocardial Infarction and Stroke, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vascular occlusive events (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2011; AzTrials last refreshed its copy on 6 Nov 2026.