Statin Drugs to Prevent Complications During Surgery

NCT00967434 | Completed DMC

• 1 other identifier: 2006832-01H
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Inflammation; Myocardial Infarction; Myocardial Ischemia

Keywords

infarction; ischemia; surgery; perioperative; statins

Outcome Measures

Primary Outcomes (1)

• C-reactive protein levels at 48 hours postoperatively

  48 hours

Secondary Outcomes (4)

• perioperative myocardial ischemia as detected by Holter monitoring

  48 hours

• perioperative myocardial injury as measured by troponin levels

  up to 7 postoperative days

• liver enzyme levels

  up to 7 postoperative days

• myopathy as assessed by CK levels

  up to 7 postoperative days

Study Arms (3)

Group A- atorvastatin in pre and postop

ACTIVE COMPARATOR

Atorvastatin 80 mg administered daily for at least 7 preoperative days, 80 mg on day of surgery and 80 mg daily for up to 7 postoperative days.

Drug: Atorvastatin

Group B- Atorvastatin postop

ACTIVE COMPARATOR

Placebo administered for up to 7 preoperative days, atorvastatin 80 mg administered on day of surgery and daily for up to 7 postoperative days.

Drug: Atorvastatin

Group C- Placebo

PLACEBO COMPARATOR

Patients receive placebo daily for up 7 preoperative days, placebo on day of surgery and placebo daily for up to 7 postoperative days.

Drug: Placebo

Interventions

Atorvastatin DRUG

atorvastatin 80 mg daily for at least 7 preoperative days atorvastatin 80 mg on day of surgery atorvastatin 80 mg daily for up to 7 postoperative days

Also known as: lipitor

Group A- atorvastatin in pre and postop

Placebo DRUG

Daily placebo in preoperative period Placebo on day of surgery Daily placebo for up to 7 postoperative days

Group C- Placebo

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective high-risk surgery defined by use of the POISE criteria
• over 45 years of age

You may not qualify if:

• lack of informed consent
• contraindication to statin (i.e. liver insufficiency or cirrhosis, active muscular disorder or myopathy, or previous adverse reaction to statin)
• pregnant
• enrolled in another conflicting study
• previously enrolled in STAR VaS
• presently using a statin drug

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Anesthesiologists' Society: collaborator
• Heart and Stroke Foundation of Ontario: collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1Y4E9, Canada

Location

Related Publications (1)

• Neilipovitz DT, Bryson GL, Taljaard M. STAR VaS--Short Term Atorvastatin Regime for Vasculopathic Subjects: a randomized placebo-controlled trial evaluating perioperative atorvastatin therapy in noncardiac surgery. Can J Anaesth. 2012 Jun;59(6):527-37. doi: 10.1007/s12630-012-9702-z. Epub 2012 Apr 13.

  PMID: 22528165 DERIVED

MeSH Terms

Conditions

Inflammation; Myocardial Infarction; Myocardial Ischemia; Infarction; Ischemia

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Necrosis

Intervention Hierarchy (Ancestors)

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

Study Officials

• David T Neilipovitz, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

• Greg L Bryson, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2009
• First Posted: August 27, 2009
• Study Start: December 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: December 1, 2010
• Last Updated: June 12, 2018

Record last verified: 2018-06

Locations

CA (1)