MedTrace Logo

Efficacy of Different Perioperative Statin Regimens on the Protection Against Post Coronary Artery Bypass Grafting Major Adverse Cardio-cerebral Events

NCT02706860 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2016-03-14

No results posted yet for this study

Summary

This study aims at comparing different perioperative statin regimens for the prevention of post CABG adverse events.

This was a randomized, prospective clinical trial. Ninety four patients scheduled for elective, isolated on- or off- pump CABG were randomly assigned to one of 3 treatment groups; 80 mg atorvastatin/day for 2 days preoperatively (N=37), 80 mg atorvastatin/day for 5-9 days preoperatively (N=28) or 40 mg atorvastatin/day for 5-9 days preoperatively (N=29). The corresponding preoperative doses were restarted postoperatively (post-op) when patients were able to take the medication orally and were continued for one month. Cardiac troponin I (TnI), Creatine Kinase (CK-MB) and C-reactive protein (CRP) were assayed preoperatively and post-operatively at 8, 24, 48 hours, and at discharge. Marker levels were compared among the three groups. The incidence of post-operative major adverse cardiac and cerebrovascular events (MACCE) was assessed including; 30-day all-cause mortality, myocardial infarction, atrial fibrillation, ventricular tachycardia/ventricular fibrillation, stroke and target-vessel revascularization. The incidence of renal or hepatic impairment and post-operative infections were also assessed. A Quality of life (QoL) questionnaire (EQ-5D-3L) was administered preoperatively and 1 month after CABG.

Conditions

  • Coronary Artery Bypass Grafting

Interventions

DRUG

Atorvastatin

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
42 Years
Max Age
71 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-02-28
Completion
2015-02-28

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02706860 on ClinicalTrials.gov