Vascular SurgeryPhase 4APVSNCT00610545
Atorvastatin in Perioperative Vascular Surgery - Pilot Study
A Phase 4 study testing Atorvastatin in people with Vascular Surgery, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
This study is designed to determine if the use of atorvastatin (Lipitor), a member of the HMG coA reductase inhibitor class of drugs referred to as statins, will reduce cardiovascular outcomes ( mortality - myocardial infarction - stroke ) when given in high doses in comparative standard doses in the perioperative… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Vascular Surgery
- What is being tested?
- Atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2007to Dec 2008
- Phase
- Phase 4
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Vascular surgery (abdominal aortic aneurysm , carotid endarterectomy , limbs revascularization)
Who cannot join
- Pregnant or lactating women
- Patient with sensitivity to atorvastatin
- Patient has elevations in certain laboratory values (CK, AST, ALT)
- Known history of active hepatic disease or known hepatic insufficiency
- Patients participating in another clinical trial
- Prior statin therapy to include: >10 mg of atorvastatin (Lipitor) or >20 mg of other HMG-CoA Reductase Inhibitors (statins) or use rosuvastatin
- Serious infectious disease after surgery
- Known history of cancer
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Clinics Hospital - State University Campinas
Campinas, São Paulo, 13083970
About this study
Official title: Atorvastatin 80mg Versus Atorvastatin 20mg in Perioperative Vascular Surgery to Evaluate Cardiovascular Outcomes
This study is designed to determine if the use of atorvastatin (Lipitor), a member of the HMG coA reductase inhibitor class of drugs referred to as statins, will reduce cardiovascular outcomes ( mortality - myocardial infarction - stroke ) when given in high doses in comparative standard doses in the perioperative period of major vascular surgery.
Abdominal aortic aneurysm , Carotid endarterectomy , Revascularization of lower limbs
- Conditions
- Vascular Surgery
- Being tested
- Atorvastatin
- Keywords
- ATORVASTATIN, VASCULAR SURGERY, CARDIOVASCULAR OUTCOMES
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Atorvastatin 80 mg; Use Atorvastatin for 60 days , and the vascular surgery will be made between day-7 and day-60
AtorvastatinDrug
Atorvastatin 20 mg; Use Atorvastatin for 60 days , and the vascular surgery will be made between day-7 and day-60
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Use Atorvastatin 80mg for 60 days , and the vascular surgery will be made between day-7 and day-60 Receives: Drug: Atorvastatin |
| 2 | Active comparator | Use Atorvastatin 20 mg for 60 days , and the vascular surgery will be made between day-7 and day-60 Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality ; myocardial infarction ; stroke
Measured: within 90 days after surgery
Secondary outcomes (3)
Change and percent change from baseline to the surgery of treatment for LDL-C, HDL-C, TC, and TG for subjects
Measured: within 24h before surgery
Change and percent change from baseline to the surgery of treatment for hs-CRP
Measured: within 24h before surgery
Safety of atorvastatin through laboratory assessment
Measured: within 24h before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2008 (estimated)
- Study startJul 2007
- Primary completionSep 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular SurgeryStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Investigators
- OTAVIO COELHO, PhD, Study director, STATE UNIVERSITY CAMPINASRAITANY C ALMEIDA, MD, Principal investigator, STATE UNIVERSITY CAMPINAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610545
- Sponsor's protocol ID
- FCM-UNICAMP - 620/2006
- Other IDs
- 0492.0.146.000-06
- Acronym
- APVS
- Status last verified
- Feb 2009
- First submitted
- 28 Jan 2008
- Last updated
- 16 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atorvastatin 80mg Versus Atorvastatin 20mg in Perioperative Vascular Surgery to Evaluate Cardiovascular Outcomes
- ClinicalTrials.gov ID
- NCT00610545
- Acronym / sponsor ID
- APVS / FCM-UNICAMP - 620/2006
- Conditions
- Vascular Surgery
- Keywords
- ATORVASTATIN, VASCULAR SURGERY, CARDIOVASCULAR OUTCOMES
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 8 Feb 2008 (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.
This study is designed to determine if the use of atorvastatin (Lipitor), a member of the HMG coA reductase inhibitor class of drugs referred to as statins, will reduce cardiovascular outcomes ( mortality - myocardial infarction - stroke ) when given in high doses in comparative standard doses in the perioperative period of major vascular surgery.
Abdominal aortic aneurysm , Carotid endarterectomy , Revascularization of lower limbs
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: AtorvastatinUse Atorvastatin 80mg for 60 days , and the vascular surgery will be made between day-7 and day-60 |
| 2 | Active comparator | Drug: AtorvastatinUse Atorvastatin 20 mg for 60 days , and the vascular surgery will be made between day-7 and day-60 |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Vascular surgery (abdominal aortic aneurysm , carotid endarterectomy , limbs revascularization)
Key exclusion criteria (8 listed)
- Pregnant or lactating women
- Patient with sensitivity to atorvastatin
- Patient has elevations in certain laboratory values (CK, AST, ALT)
- Known history of active hepatic disease or known hepatic insufficiency
- Patients participating in another clinical 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 |
|---|---|---|
| AtorvastatinAtorvastatin 80 mg; Use Atorvastatin for 60 days , and the vascular surgery will be made between day-7 and day-60 | Drug | 1 |
| AtorvastatinAtorvastatin 20 mg; Use Atorvastatin for 60 days , and the vascular surgery will be made between day-7 and day-60 | Drug | 2 |
Primary outcome
mortality ; myocardial infarction ; stroke
Time frame: within 90 days after surgery
3 secondary outcomes
Change and percent change from baseline to the surgery of treatment for LDL-C, HDL-C, TC, and TG for subjects
Time frame: within 24h before surgery
Change and percent change from baseline to the surgery of treatment for hs-CRP
Time frame: within 24h before surgery
Safety of atorvastatin through laboratory assessment
Time frame: within 24h before surgery
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 Feb 2009.
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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.
OTAVIO COELHO, PhD study director
STATE UNIVERSITY CAMPINAS
RAITANY C ALMEIDA, MD principal investigator
STATE UNIVERSITY CAMPINAS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atorvastatin in people with Vascular Surgery, run by University of Campinas, Brazil at 1 site in Brazil.
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 1 inclusion and 8 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 Feb 2009. 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 Brazil. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
mortality ; myocardial infarction ; stroke (time frame: within 90 days after surgery). 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 Feb 2009.