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HMG-CoA reductase inhibitor

Intensive Statin Therapy Effect on Post-Operative Atrial Fibrillation (POAF)

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
Pivotal Trial
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 30 Other Conditions
Drug Has Already Been Approved

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
  • Atrial Fibrillation
  • Cardiothoracic Surgery

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Occurrence of atrial fibrillation by hospital discharge

Side effects data

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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 30 Other Conditions
This treatment demonstrated efficacy for 30 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

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
126 Previous Clinical Trials
25,526 Total Patients Enrolled
5 Trials studying Atrial Fibrillation
305 Patients Enrolled for Atrial Fibrillation
Aiman Smer, MBBChPrincipal InvestigatorCreighton University
~16 spots leftby Jan 2026