]>

IRCT20250821066938N1 IRCT 2026-04-29 Babol University of Medical Sciences Investigation of the antianginal effect of ranolazine versus high-dose nitrocardin on quality of life and symptom control in patients with stable angina pectoris with a history of coronary intervention Investigation of the antianginal effect of ranolazine versus high-dose nitrocardin on quality of life and symptom control in patients with stable angina pectoris with a history of percutaneous coronary intervention 2025-09-23 anticipated 88 Complete https://irct.ir/trial/85724 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be performed using blocks of 4 and blocks of 22, using the randomizer.org website. Patients will then be randomly assigned to receive ranolazine 500 mg every 12 hours (actoverco) or nitrocardine 6.4 mg twice daily (alborzdarou) in addition to their initial antianginal regimen. N/A patients with stable angina. Intervention group: Patients in this group will receive Ranolazine 500 mg tablets (manufactured by Actoverco) twice daily (every 12 hours) for one month, in addition to their standard anti-anginal therapy. For patients already taking Nitrates at a dose of 2.6 mg BID (twice daily), this dosage will be maintained without change.. 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 Due to ethical considerations and to ensure maximum protection of participant confidentiality, we currently have no plan to share individual participant data, even in de‑identified form. In addition, the necessary infrastructure for secure data management and controlled secondary access is not fully available at the study site. Therefore, in order to minimize any risk of unintended disclosure of participant information and in accordance with the Ethics Committee’s emphasis on data confidentiality, individual-level data will not be shared publicly or with other researchers

public Saeed Abrotan

Ganj afrooz

Babol Iran (Islamic Republic of) ۴۷۱۷۶-۴۷۷۴۵ +98 11 3219 9591 abrotan@yahoo.com Babol University of Medical Sciences scientific Saeed Abrotan

Ganj Afrooz

Babol Iran (Islamic Republic of) ۴۷۱۷۶-۴۷۷۴۵ +98 11 3219 9591 abrotan@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) The patient's age is 40 to 75 years. The patient has had chronic angina for at least one month (at least two episodes of anginal pain or discomfort in the chest, jaw, shoulders, back, neck, or arms that is aggravated by activity or emotional stress and relieved by rest or sublingual nitroglycerin, and that occur on two separate days). Patients with a documented history of coronary artery disease (including ≥60% stenosis of at least one major coronary artery on angiography, history of myocardial infarction, or stress-induced reversible ischemia as seen by radionucleotide imaging or echocardiography) and who have undergone angioplasty (percutaneous coronary intervention) at least 6 months after the procedure. Patients with EF (ejection fraction) of at least 40 percent. The patient is being treated with anti-ischemic drugs (beta blockers, calcium channel blockers, long-acting nitrates, ranolazine) for at least 2 weeks. Patients for whom the use of ranolysin is safe and in accordance with the treatment protocol. After explaining the procedure to the patient, consent must be obtained from the patient and his/her family. 40 years 70 years Both A patient with stable angina who is being treated with nitrates at maximum dose (nitrocardin 6.4mg every 12 hours or once every 8 hours) and whose pain is still not controlled. The patient has NYAH class 3 or 4 heart failure. The patient has a history of myocardial infarction or unstable angina (pain lasting more than 15 to 20 minutes) within the last 2 months. The patient has been referred to the center with acute myocardial infarction or active pericarditis. The patient has undergone coronary artery bypass grafting (CABG) surgery or a decision has been made for CABG in the future. Patients with a history of serious ventricular arrhythmias or QTc prolongation greater than 500 milliseconds. The patient has a history of stroke or transient ischemic attacks within the last 6 months. The patient has uncontrolled blood pressure. The patient has liver disorder with clear clinical evidence (including liver cirrhosis). The patient has severe renal dysfunction (GFR <30ml/min per 1.73m2) or is undergoing renal dialysis treatment. Patients taking drugs that have severe drug interactions with ranolysin (such as ketoconazole, clarithromycin, CYP3A4 inhibitor drugs). Patients who have not tolerated ranolysin in the past for any reason. Patients with inability to cooperate with the study (such as cognitive or psychiatric disorders). Pregnant or breastfeeding women. 1Patients who cannot participate during the study period due to non-medical reasons such as relocation. Treatment - Drugs Intervention group: Patients in this group will receive Ranolazine 500 mg tablets (manufactured by Actoverco) twice daily (every 12 hours) for one month, in addition to their standard anti-anginal therapy. For patients already taking Nitrates at a dose of 2.6 mg BID (twice daily), this dosage will be maintained without change. The outcome variables in this study include changes in the severity and frequency of angina symptoms as well as health-related quality of life. The severity and frequency of angina and the limitation of physical activities will be assessed using the Seattle Angina Questionnaire-7 (SAQ-7), and health-related quality of life will be evaluated using the MacNew Heart Disease Health-related Quality of Life questionnaire.Both questionnaires will be completed by the patients at baseline and at the end of the one‑month follow‑up period. Total and domain scores of each questionnaire will be calculated, and the changes in these scores between baseline and follow‑up will be compared between the two treatment groups. Timepoint: At two time points: at baseline (before initiation of the intervention) and at the end of the one‑month follow‑up period after treatment initiation. Method of measurement: Variables will be measured using standardized self-administered questionnaires. Angina frequency, angina burden and physical limitation will be assessed using the Seattle Angina Questionnaire‑7 (SAQ‑7), and health-related quality of life will be evaluated using the MacNew Heart Disease HRQoL questionnaire.Both questionnaires will be completed by patients at two time points (baseline and at the end of the one‑month follow‑up). For each patient, total and domain scores will be calculated according to the standard scoring instructions, and changes from baseline will be compared between the two treatment groups. Babol University of Medical Sciences Approved 2025-05-13 Ethics committee of Babol University of Medical Sciences Ganjafrooz Blvd., Babol Town Babol Mazandaran Iran (Islamic Republic of)