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IRCT20220515054863N2 IRCT 2022-11-01 Tehran University of Medical Sciences Efficacy of Ranolazine in treating ventricular premature beats Comparison of the efficacy of Ranolazine with placebo for reducing ventricular premature beats (VPBs) in patients with high burden of VPBs in holter monitoring 2022-12-01 anticipated 96 Complete https://irct.ir/trial/66483 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible participants will be randomized to two 1:1 parallel arms receiving ranolazine or placebo. The random sequence will be generated by R software "blockrand" package, with the method of block randomization in block sizes of 2, 4, and 6. Trial medications (ranolazine and placebo) will be identical in appearance, and stored in sequentially numbered sealed opaque unlabeled boxing. An unblinded investigator will put a number on the medications’ boxing prior to the start of recruitment, according to the random sequence. Each patient who is enrolled will receive the appropriate sequentially numbered and blinded box of medications, which contains pills prescribed for the duration of the study. Patients will receive medications after enrollment, completion of baseline forms, and providing informed consent. A randomization log will be kept at the recruitment site to ensure sequential allocation of treatments. Allocation concealment is ensured by using variable block sizes. Moreover, the ranolazine and placebo pills and their boxing are completely identical; therefore, guessing the next treatment allocation would not be possible, Blinding description: Blinding will be achieved through using ranolazine and placebo pills that are identical in appearance, and are manufactured by the same pharmaceutical company (Koushan Pharmed). Participants, the principal investigator, the echocardiography specialist, the recruiting physician, the outcome assessor, and nurse investigators who collect data and complete forms will all be blinded in the trial. Each participant receives a unique code and all of the forms will be filled out based on the code. During the statistical analysis, it will be determined whether each code is related to Ranolazine or placebo. N/A premature ventricular beats, ventricular premature depolarization, premature ventricular complexes, premature ventricular contraction. Intervention 1: Intervention group: Drug name: Ranolazine, formula: C24H33N3O4, dose: 1000 mg Bid for 30 days, company: Koushan Pharmed. Intervention 2: Control group: placebo, company: Koushan Pharmed. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Undecided - It is not yet known if there will be a plan to make this available
public Masih Tajdini
Tehran Heart Center, Kargar st
Tehran Iran (Islamic Republic of) 1411713138 +98 21 8802 9600 mtajdini@sina.tums.ac.ir Tehran University of Medical Sciences scientific Ali Bozorgi
Tehran Heart Center, Kargar st
Tehran Iran (Islamic Republic of) 1411713138 +98 21 8802 9600 alibozorgi2001@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Minimum age of 18 PVC burden between 10 to 30 percent among whole beats 18 years no limit Both Patients with Atrial Fibrillation (AF) Patients diagnosed with ischemic ventricular tachycardia (VT) Patients with a history of serious ventricular tachyarrhythmias in the past 4 weeks (e.g., sustained ventricular tachycardia and ventricular fibrillation) Patients who have a QT interval higher than 550 milliseconds or consume medications that prolong the QT interval Patients with a heart transplant Patients undergoing dialysis Patients with a creatinine clearance below 30 ml/min or a blood creatinine over 2.5 mg/dl Patients with moderate to severe hepatic dysfunction Patients receiving metformin with a dose extending 1000 mg Bid Patients receiving simvastatin with a daily dose extending 20 mg Patients receiving Dabigatran Patients receiving a CYP3A4 inhibitor (Ketoconazole, Clarithromycin, Ritonavir, Diltiazem, Fluconazole, Erythromycin, Verapamil or grapefruit juice) Patients with a history of Ranolazine consumption in the past two months Patients who have previously discontinued Ranolazine due to side effects Pregnant or breastfeeding patients, or patients planning for pregnancy during the study period Patients without informed consent I49.3 Ventricular premature depolarization Treatment - Drugs Placebo Intervention group: Drug name: Ranolazine, formula: C24H33N3O4, dose: 1000 mg Bid for 30 days, company: Koushan Pharmed Control group: placebo, company: Koushan Pharmed Difference in PVC burden on holter before and after treatment. Timepoint: 30 days. Method of measurement: Holter monitoring at the time of enrollment and 30 days after receiving therapy. Any patient-reported side effects. Timepoint: 30 days. Method of measurement: interview. Koushan Pharmed Tehran University of Medical Sciences Koushan Pharmed Approved 2022-10-31 Ethics Committee of Tehran Heart Center-Tehran University of Medical Sciences Tehran Heart Center, Kargar st Tehran Tehran Iran (Islamic Republic of)