Study to Evaluate the Effect of Ranolazine and Dronedarone When Given Alone and in Combination in Patients With Paroxysmal Atrial Fibrillation
NCT ID: NCT01522651
Last Updated: 2020-11-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
134 participants
INTERVENTIONAL
2012-01-24
2014-03-10
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Ranolazine placebo plus dronedarone placebo for 12 weeks.
Ranolazine placebo
Tablets administered orally twice daily.
Dronedarone placebo
Capsules administered orally twice daily
Ranolazine 750 mg
Ranolazine 750 mg plus dronedarone placebo for 12 weeks.
Ranolazine
Tablets administered orally twice daily.
Dronedarone placebo
Capsules administered orally twice daily
Dronedarone 225 mg
Ranolazine placebo plus dronedarone 225 mg for 12 weeks.
Dronedarone
Capsule administered orally twice daily
Ranolazine placebo
Tablets administered orally twice daily.
Ranolazine 750 mg + Dronedarone 225 mg
Ranolazine 750 mg plus dronedarone 225 mg for 12 weeks.
Ranolazine
Tablets administered orally twice daily.
Dronedarone
Capsule administered orally twice daily
Ranolazine 750 mg + Dronedarone 150 mg
Ranolazine 750 mg plus dronedarone 150 mg for 12 weeks.
Ranolazine
Tablets administered orally twice daily.
Dronedarone
Capsule administered orally twice daily
Interventions
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Ranolazine
Tablets administered orally twice daily.
Dronedarone
Capsule administered orally twice daily
Ranolazine placebo
Tablets administered orally twice daily.
Dronedarone placebo
Capsules administered orally twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Investigational Site
Beverly Hills, California, United States
Investigational Site
Newport Beach, California, United States
Investigational Site
San Francisco, California, United States
Investigational Site
Aurora, Colorado, United States
Investigational Site
Washington D.C., District of Columbia, United States
Investigational Site
Lakeland, Florida, United States
Investigational Site
Takoma Park, Maryland, United States
Investigational Site
Towson, Maryland, United States
Investigational Site
Utica, New York, United States
Investigational Site
Cleveland, Ohio, United States
Investigational Site
Warwick, Rhode Island, United States
Investigational Site
Houston, Texas, United States
Investigational Site
Murray, Utah, United States
Investigational Site
Seattle, Washington, United States
Investigational Site
Wausau, Wisconsin, United States
Investigational Site
München, Bavaria, Germany
Investigational Site
Würzburg, Bavaria, Germany
Investigational Site
Bonn, North Rhine-Westphalia, Germany
Investigational Site
Coburg, , Germany
Investigational Site
Frankfurt, , Germany
Investigational Site
Göttingen, , Germany
Investigational Site
Ingolstadt, , Germany
Investigational Site
Lübeck, , Germany
Investigational Site
Ashkelon, Ashqelon, Israel
Investigational Site
Afula, Zefat, Israel
Investigational Site
Hadera, , Israel
Investigational Site
Haifa, , Israel
Investigational Site
Holon, , Israel
Investigational Site
Jerusalem, , Israel
Investigational Site
Nahariya, , Israel
Investigational Site
Rehovot, , Israel
Investigational Site
Como, , Italy
Investigational Site
Florence, , Italy
Investigational Site
Maastricht, Limburg, Netherlands
Investigational Site
Groningen, , Netherlands
Investigational Site
Poznan, Greater Poland Voivodeship, Poland
Investigational Site
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Investigational Site
Krakow, Lesser Poland Voivodeship, Poland
Investigational Site
Warsaw, Masovian Voivodeship, Poland
Investigational Site
Warsaw, Masovian Voivodeship, Poland
Investigational Site
Bialystok, Podlaskie Voivodeship, Poland
Investigational Site
Gdansk, Pomeranian Voivodeship, Poland
Investigational Site
Sopot, Pomeranian Voivodeship, Poland
Investigational Site
Katowice, Silesian Voivodeship, Poland
Investigational Site
Zabrze, Silesian Voivodeship, Poland
Investigational Site
Szczecin, Zachodniop, Poland
Investigational Site
Lodz, , Poland
Investigational Site
Warsaw, , Poland
Investigational Site
Lodz, Łódź Voivodeship, Poland
Investigational Site
London, England, United Kingdom
Countries
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References
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Reiffel JA, Camm AJ, Belardinelli L, Zeng D, Karwatowska-Prokopczuk E, Olmsted A, Zareba W, Rosero S, Kowey P; HARMONY Investigators. The HARMONY Trial: Combined Ranolazine and Dronedarone in the Management of Paroxysmal Atrial Fibrillation: Mechanistic and Therapeutic Synergism. Circ Arrhythm Electrophysiol. 2015 Oct;8(5):1048-56. doi: 10.1161/CIRCEP.115.002856. Epub 2015 Jul 30.
Other Identifiers
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2011-001134-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-291-0102
Identifier Type: -
Identifier Source: org_study_id