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IRCT20220516054874N6 IRCT 2022-09-24 Mashhad University of Medical Sciences Evaluation of the effect of Ranolazine on patients with slow flow coronary arteries Evaluation of the effect of oral Ranolazine on the clinical symptoms of patients with slow flow coronary arteries 2022-10-07 anticipated 48 Complete https://irct.ir/trial/65998 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The blocked randomization method is used. The volume of each block will be four. Then the list of blocks is written and numbers assigned to them, for example (AABB(1)- BBAA(2)- BABA(3)- BAAB(4)), which will be 12 blocks according to the sample size of 48. Then random numbers between 1 and 12 are selected according to the randomization site Randomaization.com and finally, the treatment allocation list is determined based on the random numbers, Blinding description: Using sealed envelopes Due to the use of a placebo similar to the intervention treatment, the investigator and the participants will not be informed of the assigned treatment, and the analyst will also be unaware of the assigned treatment for the two groups. Finally, after analyzing the data, the researcher who prepared the packages will reveal the codes A and B. 2 Coronary slow flow syndrome. Intervention 1: Intervention group: Patients who have less than 50% stenosis in each of the 3 main coronary arteries in their coronary angiography and have delayed filling in at least one of the coronary arteries and have slow coronary flow in a corrected TIMI frame count of more than 27 frames per second are considered to have slow coronary artery disease. They received routine treatment (including aspirin, statins, beta-blockers and angiotensin-converting enzyme inhibitors) along with oral ranolazine at a dose of 500 mg twice daily for two months. Intervention 2: Control group: Intervention group: Patients who have less than 50% stenosis in each of the 3 main coronary arteries in their coronary angiography and have delayed filling in at least one of the coronary arteries and have slow coronary flow in a corrected TIMI frame count of more than 27 frames per second are considered to have slow coronary artery disease. They received routine treatment (including aspirin, statins, beta-blockers and angiotensin-converting enzyme inhibitors) along with oral placebo tablet with shape, size, and color similar to ranolazine twice daily for two months. 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 It is not yet known if there will be a plan to make this available
public Dr. Vafa Baradaran Rahimi
Ghaeem hospital, Ahmadabad Blvd, Mashhad
Mashhad Iran (Islamic Republic of) 9177948564 0095 5138012739 baradaranrv@mums.ac.ir Mashhad University of Medical Sciences scientific Dr. Vafa Baradaran Rahimi
Ghaeem hospital, Ahmadabad Blvd, Mashhad
Mashhad Iran (Islamic Republic of) 9177948564 0095 5138012739 baradaranrv@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Consent to admission to the study Age more than 30 years old Patients who have less than 50% stenosis in each of the 3 main coronary arteries in their coronary angiography and have delayed filling in at least one of the coronary arteries and have slow coronary flow in a corrected TIMI frame count of more than 27 frames per second 30 years no limit Both Intolerance or allergy to Ranolazine History of known congenital heart disease History of any cardiovascular diseases other than mild coronary atherosclerosis I20.8 Other forms of angina pectoris Treatment - Drugs Placebo Intervention group: Patients who have less than 50% stenosis in each of the 3 main coronary arteries in their coronary angiography and have delayed filling in at least one of the coronary arteries and have slow coronary flow in a corrected TIMI frame count of more than 27 frames per second are considered to have slow coronary artery disease. They received routine treatment (including aspirin, statins, beta-blockers and angiotensin-converting enzyme inhibitors) along with oral ranolazine at a dose of 500 mg twice daily for two months. Control group: Intervention group: Patients who have less than 50% stenosis in each of the 3 main coronary arteries in their coronary angiography and have delayed filling in at least one of the coronary arteries and have slow coronary flow in a corrected TIMI frame count of more than 27 frames per second are considered to have slow coronary artery disease. They received routine treatment (including aspirin, statins, beta-blockers and angiotensin-converting enzyme inhibitors) along with oral placebo tablet with shape, size, and color similar to ranolazine twice daily for two months. Changes in the score of quality of life according to the EuroQol-VAS scale (0-100; 100 is the best quality of life and 0 is the worst quality of life). Timepoint: Before intervention and 1, and 2 months after beginning the intervention. Method of measurement: According to the EuroQol-VAS scale (0-100; 100 is the best quality of life and 0 is the worst quality of life). Frequent pain during the day. Timepoint: Before intervention and 1, and 2 months after beginning the intervention. Method of measurement: Frequent pain during the day. Duration of pain in minutes. Timepoint: Before intervention and 1, and 2 months after beginning the intervention. Method of measurement: Duration of pain in minutes. Pain intensity based on activity according to Canadian Cardiovascular Society (CCS) Grading of Angina Pectoris. Timepoint: Before intervention and 1, and 2 months after beginning the intervention. Method of measurement: According to Canadian Cardiovascular Society (CCS) Grading of Angina Pectoris. Mashhad University of Medical Sciences Approved 2022-05-31 Ethic's committee of School of Medicine, Mashhad University of Medical Sciences Faculty of Medicine, Ferdowsi University complex, Azadi Sq., Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)