CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 648 enrolled
Drug / intervention
Atorvastatin +1 moredrug
Likely dose
Atorvastatin 80mgfrom 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/NCT01543555
NCT01543555Phase 3Completed
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Multicenter Randomized Controlled Trial of Loading Dose Statins for the Prevention of Cardiovascular Complications in High-Risk Non-Cardiac Surgery

Hospital do Coracao·interventional·Posted Mar 5, 2012·Updated Dec 31, 2015

In Brief

A Phase 3 clinical trial evaluating Atorvastatin and Placebo for Myocardial Infarction and 2 related conditions. Completed, enrolled 648 participants across 1 site.

Detailed Summary

Patients submitted to noncardiac surgeries are at increased risk of serious cardiovascular complications. Statins have shown to lower cholesterol levels and reduce cardiovascular events in other scenarios. The objective of this study is to explore the effects of atorvastatin, as compared with placebo, on the 30-day risk of a composite of death, nonfatal Myocardial Injury after Noncardiac Surgery (MINS), or stroke among patients who undergo noncardiac surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyocardial Infarction, Peripheral Vascular Disease, Aortic Aneurism
CountriesBrazil
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 5, 2012
Enrollment StartNov 1, 2012
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 14.3 years ago

Interventions

Atorvastatindrug

Atorvastatin 80mg anytime within 18 hours before surgery. A postoperative 40mg atorvastatin dose administered at least 12 hours after the 80mg loading dose. Subsequently, 40mg atorvastatin daily for the next seven days.

Placebodrug

Matching placebo 80mg anytime within 18 hours before surgery. A postoperative 40mg matching placebo dose administered at least 12 hours after the 80mg loading dose. Subsequently, 40mg placebo daily for the next seven days.