]>
IRCT20221228056964N1 IRCT 2023-01-17 Qazvin University of Medical Sciences The effect of adding Nicorandil to the three-drug regimen on the quality of life in patients with Coronary slow blood flow disease The effect of Aspirin, Statin, Nitrate drug regimen on the quality of life in patients with Coronary slow flow disease and its comparison with the addition of Nicorandil 2023-01-21 anticipated 56 Complete https://irct.ir/trial/67739 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients are allocated to one of the two intervention groups using the random block sampling method. Random allocation software version 2 with a fixed size of 4 is used to generate randomized blocks. The principal investigator and the patients are unaware of the assigned treatment group. 3 Slow flow coronary disease. Intervention 1: First arm: conventional three-drug regimen of aspirin 80 mg/day, statin 20 mg/day, and nitroglycerin 2.6 mg twice daily for 2 months. Intervention 2: Second arm: a conventional regimen of three drugs (Aspirin 80 mg/day, Statin 20 mg/day, and Nitroglycerin 2.6 mg twice daily) along with 10 mg of Merck's Adancor brand Nicorandil twice daily. 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 The decision is made with the coordination of the academic medical ethics committee
public Hamidreza Javadi
Department of Cardiovascular Diseases, Bu Ali Sina hospital, Bu Ali Sina Street
Qazvin Iran (Islamic Republic of) 34137-86165 +98 28 3333 2930 javadi.hr@gmail.com Qazvin University of Medical Sciences scientific Hamidreza Javadi
Department of Cardiovascular Diseases, Bu Ali Sina hospital, Bu Ali Sina Street
Qazvin Iran (Islamic Republic of) 34137,86165 +98 28 3333 2930 javadi.hr@gmail.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Patients referred to Bu-Ali Sina Referral Center who are candidates for coronary angiography based on clinical criteria, echocardiography, or other causes except for acute myocardial infarction or its history and complications (such as arrhythmias or conduction disorders), and then using The relevant criteria for diagnosing slow flow coronary syndrome are set for them. 20 years no limit Both Patients with a history of Myocardial infarction, Coronary artery bypass graft surgery, Percutaneous coronary intervention, Heart failure, Valvular heart disease, connective tissue disorders, Atrio-ventricular conduction disorders, Chronic obstructive pulmonary disease, Electrolyte disturbance, Chronic kidney disease, Anemia, and Systemic Hypertension are excluded from the study. After coronary angiography, patients with coronary slow flow due to secondary causes including Coronary artery ectasia, Coronary artery aneurysm, Coronary artery spasm, Air embolism during the procedure, and Congenital anomalies of coronary arteries are excluded from the study. Patients who do not agree to participate in the plan for any reason or decide to withdraw from the plan at any time. I20.8 Other forms of angina pectoris Rehabilitation Rehabilitation First arm: conventional three-drug regimen of aspirin 80 mg/day, statin 20 mg/day, and nitroglycerin 2.6 mg twice daily for 2 months. Second arm: a conventional regimen of three drugs (Aspirin 80 mg/day, Statin 20 mg/day, and Nitroglycerin 2.6 mg twice daily) along with 10 mg of Merck's Adancor brand Nicorandil twice daily Reduction of patients' symptoms. Timepoint: Before and after the end of the medication period. Method of measurement: Clinical signs and symptoms. Improving the patients quality of life. Timepoint: Before and after the end of the medication period. Method of measurement: McNew Quality of life Questionnaire. Qazvin University of Medical Sciences Approved 2022-12-21 Ethics committee of Qazvin University of Medical Sciences Department of Cardiovascular Diseases, Bu Ali Sina hospital, Bu Ali Sina Street Qazvin Qazvin Iran (Islamic Republic of)