Clareo Health | Study to Evaluate the Effect of Ranolazine and Dronedarone When Given Alone and in Combination in Patients With Paroxysmal Atrial Fibrillation
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Males and females aged 18 years and older
Have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
History of PAF documented within the prior 12 months
\- Patients with PAF undergoing cardioversion greater than 4 weeks prior to Screening are eligible
Implanted (at least 3 months prior to Screening) dual chamber programmable pacemakers with AF detection capabilities
AFB ≥ 1% and ≤ 70% between the last clinic evaluation and Screening (minimum of 1 month observation period) and AFB ≥ 2% and ≤ 70% during the Run in period
Sexually active females of childbearing potential must agree to utilize effective methods of contraception during heterosexual intercourse throughout the treatment period and for 14 days following discontinuation of the study medication
You may not be if
Disease - specific:
Persistent AF or Permanent AF
History of atrial flutter or atrial tachycardia without successful ablation
Other acutely reversible causes of AF, including but not limited to: hyperthyroidism, pericarditis, myocarditis, or pulmonary embolism
New York Heart Association (NYHA) Class III and IV heart failure or NYHA Class II heart failure with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic within 4 weeks prior to Screening.
Recent history of left ventricular ejection fraction (LVEF) \< 40%
Myocardial infarction, unstable angina, or coronary artery bypass graft (CABG) surgery within three months prior to Screening or percutaneous coronary intervention (PCI) within 4 weeks prior to Screening
Clinically significant valvular disease in the opinion of the Investigator
Stroke within 3 months prior to Screening
History of serious ventricular arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation) within 4 weeks prior to Screening
Family history of long QT syndrome
Corrected QT interval (QTc) ≥ 500 msec (Bazett) at Screening ECG if in sinus rhythm (SR). If in AF, evidence of QTc ≥ 500 msec (Bazett) within 4 weeks prior to Screening
Prior heart transplant
Cardiac ablation within 4 months prior to Screening, or planned ablation during the course of the study
Concomitant medications/food
Need for concomitant treatment during the trial, with drugs or products that are strong inhibitors of cytochrome P450 3A (CYP3A), or inducers of CYP3A
\- Such medications should be discontinued 5-half lives prior to the Run-in period
Use of grapefruit juice or Seville orange juice during the study
Use of Class I and Class III antiarrhythmic drugs other than amiodarone within 5-half lives prior to the Run-in period
Use of amiodarone within 3 months prior to Screening
Use of drugs that prolong the QT interval
Previous use of ranolazine or dronedarone within 2 months prior to screening
Prior use of ranolazine or dronedarone which was discontinued for safety or tolerability
Use of dabigatran during the study
Use of digitalis preparations (eg, digoxin) during the study
Use of a greater than 1000 mg total daily dose of metformin during the study
Laboratory tests:
Hypokalemia (serum potassium \< 3.5 mEq/L) at Screening that cannot be corrected to a level of potassium ≥ 3.5 mEq/L prior to randomization
Moderate and severe hepatic impairment (ie, Child-Pugh Class B and C), abnormal liver function test defined as alanine aminotransferase (ALT), aspartate aminotransferase (AST), or bilirubin \> 2 x upper limit of normal (ULN) at Screening
Severe renal impairment defined as creatinine clearance ≤ 30 mL/min at Screening
Others:
Females who are pregnant or are breastfeeding
In the judgment of the Investigator, any clinically-significant ongoing medical condition that might jeopardize the individual's safety or interfere with the study, including participation in another clinical trial within the previous 30 days using a therapeutic modality which could have potential residual effects that might confound the results of this study
Any device-related technical issue which in the judgment of the investigator would disrupt adequate data collection or interpretation (eg, anticipated pulse generator change or lead revision)
