Paroxysmal Atrial Fibrillation: Role of Inflammation, Oxidative Stress Injury and Effect of Statins

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00321802

Acronym

PAFRIOSIES

Enrollment

Registered

2006-05-04

Start date

2006-04-30

Completion date

2012-12-31

Last updated

2015-01-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation, statin therapy, CRP levels, Paroxysmal Atrial Fibrillation

Brief summary

The purpose of this study is to determine the effect of statin therapy for prevention of atrial fibrillation (AF) in pacemaker and non-pacemaker patients with paroxysmal atrial fibrillation in the absence of significant coronary artery disease.

Detailed description

Patients with a history of paroxysmal atrial fibrillation, with or without a dual chamber pacemaker and who meet all study criteria, will be randomized to receive either a placebo, or simvastatin 40 mg, daily for 6 months. Liver enzymes are drawn at randomization and 3 months. CRP and oxidative stress products are drawn at randomization, weekly for the first month and then monthly for 5 months. Patients transmit their rhythm, twice daily for 5 consecutive days at randomization, then 5 consecutive days monthly for 6 months. Clinic visits are required at randomization, 3 months and 6 months.

Interventions

DRUGSimvastatin

Patients take 40 mg of simvastatin per day for 6 months.

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Patients with paroxysmal AF (\> 3 epis each \> 15 min in length) over 6 months * Patients on stable antiarrhythmic drug therapy and life expectancy \> 1 year

Exclusion criteria

* Patients with PAF due to reversible cause * Chronic inflammatory conditions * Other medical conditions requiring statin therapy * Patients on amiodarone or verapamil * Elevated CK or ALT * Life expectancy \<1 year * TAVN ablation * Geographic isolation * Inability to give informed consent

Design outcomes

Primary

Measure	Time frame
Time to first detected AF	6 Months

Secondary

Measure	Time frame
Changes in CRP and oxidative stress levels over time and their relationship with AF burden	6 Months

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026