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

NCT02706860 | Completed Phase 4

• 1 other identifier: CL (775)
• Study Type: interventional
• Target: 94
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative major adverse cardiocerebral events

  30 days

Study Arms (3)

"80 mg atorvastatin for 2 days" regimen

EXPERIMENTAL

80 mg atorvastatin/ day for 2 days before coronary artery bypass grafting. This dose was restarted postoperative and continued for 1 month.

Drug: Atorvastatin

"40 mg atorvastatin for 5-9 days preoperative" regime

EXPERIMENTAL

40 mg atorvastatin/ day for 5-9 days before coronary artery bypass grafting. This dose was restarted postoperative and continued for 1 month.

Drug: Atorvastatin

"80 mg atorvastatin for 5-9 days preoperative" regime

EXPERIMENTAL

80 mg atorvastatin/ day for 5-9 days before coronary artery bypass grafting. This dose was restarted postoperative and continued for 1 month.

Drug: Atorvastatin

Interventions

Atorvastatin DRUG

"40 mg atorvastatin for 5-9 days preoperative" regime; "80 mg atorvastatin for 2 days" regimen; "80 mg atorvastatin for 5-9 days preoperative" regime

Eligibility Criteria

• Age: 42 Years - 71 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ischemic Heart Disease patients referred for elective isolated on- or off- pump CABG
• Adult patients with normal preoperative hemoglobin, hematocrit, albumin, cardiac markers; Cardiac troponin I (TnI) and Creatine Kinase-MB (CK-MB) levels.
• Serum creatinine \< 2 mg/dl and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 times upper normal limit (UNL).

You may not qualify if:

• Recent history of stroke, myocardial infarction (MI), atrial fibrillation (AF) or any other type of arrhythmias.
• Any malignancy, inflammatory or muscle disease were not included in this study.
• Hypersensitivity to statins or on medications that are known to interact with statins.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Atorvastatin

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant, Clinical Pharmacy Department, Faculty of Pharmacy, Cairo University)

Study Record Dates

• First Submitted: March 8, 2016
• First Posted: March 11, 2016
• Study Start: June 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: March 14, 2016

Record last verified: 2016-03