Ignite Creation Date:
2024-05-05 @ 9:48 PM
Last Modification Date:
2024-10-26 @ 10:09 AM
Study NCT ID:
NCT00967434
Status:
COMPLETED
Last Update Posted:
2018-06-12
First Post:
2009-08-26
Brief Title:
Statin Drugs to Prevent Complications During Surgery
Sponsor:
Ottawa Hospital Research Institute
Organization:
Ottawa Hospital Research Institute
Study Overview
Official Title:
Short Term Atorvastatin Regime for Vasculopathic Surgical STAR-VaS Patients Study
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAR-VaS
Brief Summary:
Patients undergoing non-cardiac surgery frequently experience perioperative cardiac complications that may be due to excess inflammatory reactions Lipid lowering drugs called HMG-CoA reductase inhibitors or statins have anti-inflammatory effects Although favourable evidence suggests these drugs could also prevent perioperative cardiac complications definitive evidence of anti-inflammatory effects and benefit is lacking The purpose of this study to measure the impact of a atorvastatin on patients undergoing surgery It will attempt to determine the speed of drug effect as measured by the impact the drug has on the levels of the inflammatory mediator called C-reactive protein after surgery It is hypothesized that the perioperative use of atorvastatin will safely reduce the postoperative rise in CRP levels at 48 hours after elective vascular surgery This effect would then translate into a reduction of adverse perioperative complications including reduction in postoperative myocardial ischemia episodes as measured through Holter monitoring
Detailed Description:
Despite modern improvements in operative care non-cardiac surgery is still associated with significant and costly cardiac complications The incidence of major perioperative cardiac events varies ranging from 1 in unselected populations to 15 or more in vascular surgical patients An estimated 2 million North Americans yearly experience a perioperative cardiac event with an associated mortality of 30-50 and financial burden of over 20 billion dollars Best evidence suggests that medical optimization is the preferred strategy to reduce the risks There exists favorable physiologic evidence and promising clinical observations that statin drugs may prevent perioperative complications We propose a randomized controlled trial to evaluate short-term atorvastatin versus placebo on inflammatory changes and myocardial ischemia in patients undergoing high-risk non-cardiac surgery
The traditional belief on the etiology of perioperative myocardial events has been that supply-demand discrepancies due to hypotension or hypoxia compromise cardiac oxygen delivery thus resulting in myocardial ischemia and infarction are in dispute Therapies that target supply-demand imbalance including perioperative beta-blockers have been disappointing Emerging evidence now suggests that most perioperative cardiac events are similar to non-operative events where rupture of coronary plaques and thrombosis are central to the development of acute coronary events Key elements to plaque rupture are inflammation and endothelial dysfunction Elevated inflammatory markers particularly C-reactive protein is associated with adverse cardiac events Drugs known as statins offer benefits beyond their traditional improvement of lipid levels Statins have so-called pleiotropic effects that include anti-inflammatory endothelial function changes and plaque stabilization Atorvastatin a statin with a good safety profile is particularly effective at improving inflammatory levels and decreasing cardiac events including death
Perioperatively elevated C-reactive protein levels after surgery are associated with perioperative complications including cardiac events Thus strategies to control perioperative inflammation may reduce complications Retrospective studies and small prospective studies suggest that statins would reduce perioperative complications but definitive evidence is lacking Questions regarding dose and timing of dosing is unclear Likewise little is proven on the potential pathophysiology of atorvastatin on reducing perioperative myocardial events Our hypothesis is that atorvastatin use will reduce the postoperative rise in CRP levels at 48 hours
Eligible non-cardiac surgical patients will be randomized into 3 groups with 3 stages of treatment namely stage 1 preoperative period up to 7 days stage 2 immediate preoperative and stage 3 first 7 postoperative days Group A will receive atorvastatin in all 3 stages Group B receives placebo in stage 1 but atorvastatin stages 2 and 3 Group C receives placebo in all 3 stages Atorvastatin dose in all cases will be 80 mg C-reactive protein and lipid levels assess statin effects Safety is assessed by liver enzymes and CK levels Myocardial events assessed by troponin T ECG and Holter monitoring Follow-up at 6 months will be done
The traditional belief on the etiology of perioperative myocardial events has been that supply-demand discrepancies due to hypotension or hypoxia compromise cardiac oxygen delivery thus resulting in myocardial ischemia and infarction are in dispute Therapies that target supply-demand imbalance including perioperative beta-blockers have been disappointing Emerging evidence now suggests that most perioperative cardiac events are similar to non-operative events where rupture of coronary plaques and thrombosis are central to the development of acute coronary events Key elements to plaque rupture are inflammation and endothelial dysfunction Elevated inflammatory markers particularly C-reactive protein is associated with adverse cardiac events Drugs known as statins offer benefits beyond their traditional improvement of lipid levels Statins have so-called pleiotropic effects that include anti-inflammatory endothelial function changes and plaque stabilization Atorvastatin a statin with a good safety profile is particularly effective at improving inflammatory levels and decreasing cardiac events including death
Perioperatively elevated C-reactive protein levels after surgery are associated with perioperative complications including cardiac events Thus strategies to control perioperative inflammation may reduce complications Retrospective studies and small prospective studies suggest that statins would reduce perioperative complications but definitive evidence is lacking Questions regarding dose and timing of dosing is unclear Likewise little is proven on the potential pathophysiology of atorvastatin on reducing perioperative myocardial events Our hypothesis is that atorvastatin use will reduce the postoperative rise in CRP levels at 48 hours
Eligible non-cardiac surgical patients will be randomized into 3 groups with 3 stages of treatment namely stage 1 preoperative period up to 7 days stage 2 immediate preoperative and stage 3 first 7 postoperative days Group A will receive atorvastatin in all 3 stages Group B receives placebo in stage 1 but atorvastatin stages 2 and 3 Group C receives placebo in all 3 stages Atorvastatin dose in all cases will be 80 mg C-reactive protein and lipid levels assess statin effects Safety is assessed by liver enzymes and CK levels Myocardial events assessed by troponin T ECG and Holter monitoring Follow-up at 6 months will be done
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None