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Placebo

Ranolazine for Atrial Fibrillation (SARA Trial)

Phase 4
Waitlist Available
Led By Erik J SIrulnick, MD
Research Sponsored by Cardiovascular Consultants of Nevada
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 3 months
Awards & highlights

SARA Trial Summary

Ranolazine is an effective and remarkably safe agent for the treatment of patients with chronic stable angina, but its inhibition of voltage gated potassium channels and electrocardiogram (EKG) corrected QT (QTc) prolongation properties have lead many to question its safety when combined with antiarrhythmic drugs. The investigators have proposed a study to determine the safety of ranolazine in patients with chronic stable angina who also take amiodarone. And are conducting a prospective single-center randomized single-blinded placebo controlled trial to run out of our large cardiology practice setting at Cardiovascular Consultants of Nevada. The hypothesis is that there will be no difference in the ventricular arrhythmia burden. The primary outcome will be the measurement of ventricular arrhythmia episodes on serial holter monitor and other serially acquired recordings (such as electrocardiogram, pacemaker or implantable defibrillator (ICD) data, and stress test data) over a three month trial period.

Eligible Conditions
  • Atrial Fibrillation
  • Coronary Artery Disease
  • Chronic Stable Angina
  • Ventricular Tachycardia

SARA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ventricular arrhythmia
Secondary outcome measures
Electrocardiogram (EKG) corrected QT (QTc) interval measurement
atrial arrhythmia burden
hospitalization
+2 more

SARA Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: RanolazineActive Control1 Intervention
500 mg twice daily, titrated to 1000 mg twice daily if needed for relief of anginal symptoms
Group II: sugar pillPlacebo Group1 Intervention
one pill twice daily, uptitrated to two pills twice daily to mirror ranolazine prescription strategy

Find a Location

Who is running the clinical trial?

Cardiovascular Consultants of NevadaLead Sponsor
Gilead SciencesIndustry Sponsor
1,084 Previous Clinical Trials
848,212 Total Patients Enrolled
6 Trials studying Atrial Fibrillation
242 Patients Enrolled for Atrial Fibrillation
Erik J SIrulnick, MDPrincipal InvestigatorCardiovascular Consultants of Nevada

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~4 spots leftby May 2025