Phase 2
N=134
Study to Evaluate the Effect of Ranolazine and Dronedarone When Given Alone and in Combination in Patients With Paroxysmal Atrial Fibrillation
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT01522651 ↗Enrolled (actual)
134
Serious AEs
12.2%
Results posted
Nov 2020
Primary outcome: Primary: Atrial Fibrillation Burden (AFB) at Baseline — 12.7; 10.8; 11.6; 11.7 Percentage of total recording time
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ranolazine (Drug); Dronedarone (Drug); Ranolazine placebo (Drug); Dronedarone placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gilead Sciences
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Atrial Fibrillation Burden (AFB) at Baseline |
12.7; 10.8; 11.6; 11.7; 11.7 | — |
| PRIMARY Percent Change From Baseline in Atrial Fibrillation Burden (AFB) by Week 12 |
-5.9; -23.0; 3.5; -59.1; -45.5 | 0.493 |
| PRIMARY Absolute Change From Baseline in AFB by Week 12 |
16.8; 17.3; 19.1; 16.8; 16.7; 4.6 | — |
| SECONDARY Percentage of Participants Who Had ≥ 30%, ≥ 50%, or ≥ 70% Reduction From Baseline in AFB |
22.2; 50.0; 21.7; 45.0; 54.5; 16.7 | — |
Summary
The primary objective of this study is to evaluate the effect of ranolazine and of low-dose dronedarone when given alone and in combination at different dose levels on atrial fibrillation burden (AFB) over 12 weeks of treatment. AFB is defined as the total time a participant is in atrial tachycardia/atrial fibrillation (AT/AF) expressed as a percentage of total recording time.
Eligibility Criteria
Key Inclusion Criteria
- 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
Key Exclusion Criteria
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) 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)
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01522651). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.