Your session is about to expire
← Back to Search
Placebo
Safety of Amiodarone and Ranolazine Together in Patients With Angina (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
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial studies the safety of using ranolazine, a chest pain medication, in patients with chronic stable angina who also take amiodarone. Ranolazine is a medication originally approved by the U.S. Food and Drug Administration in 2006. The researchers will monitor heart rhythms over a few months to see if the combination of these drugs is safe.
Eligible Conditions
- Coronary Artery Disease
- Atrial Fibrillation
- Chronic Stable Angina
- Ventricular Tachycardia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
ventricular arrhythmia
Secondary study objectives
Electrocardiogram (EKG) corrected QT (QTc) interval measurement
atrial arrhythmia burden
hospitalization
+2 moreAwards & Highlights
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 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
1,137 Previous Clinical Trials
867,849 Total Patients Enrolled
18 Trials studying Coronary Artery Disease
8,854 Patients Enrolled for Coronary Artery Disease
Erik J SIrulnick, MDPrincipal InvestigatorCardiovascular Consultants of Nevada