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IRCT20230801059005N2 IRCT 2023-11-08 Shiraz University of Medical Sciences Ranolazine effects on angina pectoris in patients with coronary artery bridge Evaluation of the effect of Ranolazine added to standard treatment to control angina pectoris in patients with coronary artery bridge who underwent angiography in Alzahra Heart Hospital, Shiraz during 2023 and 2024 2023-11-08 anticipated 52 Complete https://irct.ir/trial/73353 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization, using table of random numbers, Blinding description: All investigators, patients, and follow-up team members were kept unaware of the treatment assignments throughout the study, ensuring a non-biased controlled study. 3 Myocardial bridge in coronary arteries. Intervention 1: Intervention group: For the intervention group, in addition to beta-blocker Bisoprolol Fumarate (Concor) Tablet 2.5 mg daily (Brand: Abidi), Ranolazine Tablet 500 mg daily (Xinaro 500mg) is prescribed for 6 months. Intervention 2: Control group: Bisoprolol Fumarate (Concor) 2.5 mg daily (Brand: Abidi) and Placebo is given to this group for 6 months. Yes - There is a plan to make this available What will be shared: Only a part of data like primary outcome can be shared. When: The access period starts 1 year after the publication time of results To whom: This data will be available only to researchers working in academic and scientific institutions. Conditions: The data will be made available to researchers for further studies or more advanced analysis. Where to obtain: Researchers can send an email regarding the request for the data of our study to Dr. Hamed Bazrafshan. Email: Hamedbazrafshan@yahoo.com How to obtain: The researchers can request for this study's data through an e-mail one year after the publication data of this study in one of the pee-reviewed journals. Comments:
public Yaser Rahbarian
Shiraz University of Medical Science, Zand street
Shiraz Iran (Islamic Republic of) 7196855794 +98 71 3233 4196 y.rahbaryan@gmail.com Shiraz University of Medical Sciences scientific Hamed Bazrafshan
Shiraz University of Medical Science, Zand street
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3230 5410 hamedbazrafshan@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iranian origin No history of organ damage, heart failure or renal failure Willingness to participate in research Angina or dyspnea on exertion or at rest No coronary artery disease (less than 50% stenosis in all epicardial coronary arteries) 18 years no limit Both Not willing to keep participating in the trial patients younger than 18 years Liver failure, long QT, renal failure Using CYP3A inhibitors such as Diltiazem, Verapamil, Ketoconazole, Macrolides and protease inhibitors Patient who are using medication that cause QT prolongation Pregnancy or lactation Parkinson's disease Life expectancy less than 6 months Q24.5 Malformation of coronary vessels Treatment - Drugs Treatment - Drugs Intervention group: For the intervention group, in addition to beta-blocker Bisoprolol Fumarate (Concor) Tablet 2.5 mg daily (Brand: Abidi), Ranolazine Tablet 500 mg daily (Xinaro 500mg) is prescribed for 6 months. Control group: Bisoprolol Fumarate (Concor) 2.5 mg daily (Brand: Abidi) and Placebo is given to this group for 6 months. Severity of chest pain. Timepoint: At the beginning- 6 month later. Method of measurement: Seattle Angina Questionnaire (SAQ) and The Duke Activity Status Index (DASI). Shiraz University of Medical Sciences Approved 2023-06-17 Ethics committee of Shiraz University of Medical Sciences Zand Blvd, Shiraz Shiraz Fars Iran (Islamic Republic of)