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HMG-CoA reductase inhibitor

Atorvastatin 80 mg for Atrial Fibrillation

Phase 4
Waitlist Available
Led By Aiman Smer, MBBCh
Research Sponsored by Creighton University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up hospital discharge, an expected 5-7 days
Awards & highlights

Study Summary

This study will compare the effects of 20 mg of atorvastatin to 80 mg of atorvastatin for the prevention of atrial fibrillation after cardiothoracic surgery. The study hypothesis is that 80 mg of atorvastatin will be more effective at preventing atrial fibrillation compared to 20 mg.

Eligible Conditions
  • Cardiothoracic Surgery
  • Atrial Fibrillation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~hospital discharge, an expected 5-7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and hospital discharge, an expected 5-7 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Occurrence of atrial fibrillation by hospital discharge
Secondary outcome measures
Incidence of major adverse cardiac and cardiovascular events (MACCE) at 30 days
Length of hospital stay

Side effects data

From 2013 Phase 3 trial • 59 Patients • NCT01004406
14%
Chest pain
14%
Sinusitis
10%
Otitis externa
10%
Musculoskeletal pain
5%
Hypertension
5%
Coronary artery disease
5%
Ischaemic cardiomyopathy
5%
Catheter site haemorrhage
5%
Hypertensive crisis
5%
Leukocytosis
5%
Atrial fibrillation
5%
Cholecystitis acute
5%
Dizziness
5%
Angina unstable
5%
Abdominal discomfort
5%
Gallbladder disorder
5%
Tachycardia
5%
Headache
5%
Sinus bradycardia
5%
Medical device complication
5%
Bradycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intensive LDL-lowering Therapy (ILLT)
Standard Statin Monotherapy (SMT)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Atorvastatin 80 mgExperimental Treatment1 Intervention
atorvastatin 80 mg daily 2 to 7 days prior to surgery and up to7 days post surgery
Group II: Atorvastatin 20 mgActive Control1 Intervention
atorvastatin 20 mg daily 2 to 7 days prior to surgery and up to 7 post surgery
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atorvastatin
FDA approved

Find a Location

Who is running the clinical trial?

Creighton UniversityLead Sponsor
125 Previous Clinical Trials
25,496 Total Patients Enrolled
5 Trials studying Atrial Fibrillation
305 Patients Enrolled for Atrial Fibrillation
Aiman Smer, MBBChPrincipal InvestigatorCreighton University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Intensive Statin Therapy Effect on Post-Operative Atrial Fibrillation (POAF)
2013. "Intensive Statin Therapy Effect on Post-Operative Atrial Fibrillation (POAF)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02029534.
All > Lipitor
~17 spots leftby Apr 2025
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