CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 61 enrolled
Drug / intervention
Simvastatin +1 moredrug
Likely dose
Simvastatin 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00656292
NCT00656292Phase 4Completed
CompareCT.gov

Perioperative HMG-CoA-Reductase-Inhibitors: A Pilot Study Assessing the Role of "Statin" Therapy and Perioperative Inflammatory Response in Patients Undergoing Major Orthopedic Surgery

Mayo Clinic·interventional·Posted Apr 11, 2008·Updated May 19, 2017

In Brief

A Phase 4 clinical trial evaluating Simvastatin and Placebo for Perioperative Inflammatory Response. Completed, enrolled 61 participants across 1 site.

Detailed Summary

The purpose of the present study is to quantify the degree of modulation, if any, in the perioperative inflammatory response associated with statins use. Specifically, we hypothesize that: In a population of patients undergoing elective orthopedic spine surgery, administration of a specific statin (Simvastatin, Zocor®, Merck Pharmaceuticals), will be associated with a decrease in perioperative inflammatory markers when compared to patients not taking statins

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPerioperative Inflammatory Response
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 11, 2008
Enrollment StartApr 1, 2008
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 7.9 yearsPosted 18.2 years ago

Interventions

Simvastatindrug

40 mg po/nasogastric tube (NG) every day for 6 days

Placebodrug

1 pill po/NG every day x 6 days