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IRCT20140512017666N1 IRCT 2018-03-17 Tabriz University of Medical Sciences Oral nicorandil in PPCI Study of the effect of oral nicorandil on ST-segment resolution in patients with acute ST-segment myocardial infarction undegoing primary coronary angioplasty 2018-03-20 anticipated 240 Complete https://irct.ir/trial/29917 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: block. 3 Acute ST-segment myocardial infarction. Intervention 1: Intervention group: This group receive 20 milligram nicorandil tablet in Emergency room and another 20 milligram nicorandil in catheterization laboratory just before initiation of primary angioplasty.nicorandil tablets are made by Sanofi company.Nicorandil, a nicotinamide ester ,leads to relaxation of smooth tonic vascular muscles in both venous and arterial part of vessels via opening of potassium channel.Its major effect is vasodilation of coronary arteries and relief of ischemia. Intervention 2: Control group: this group receives routine primary angioplasty and routine anti-ischemic drugs. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Ahmad Separham
Daneshgah street-Madani heart center-cardiology department
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3337 3903 separham@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Ahmad Separham
Daneshgah street-Madani heart center-cardiology department
Tabiz Iran (Islamic Republic of) 5166614756 +98 41 3337 3903 separham@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) patients with first acute STEMI treated with primary angioplasty STEMI definition: Anginal chest pain more than 20 minutes,admission within 12 hours of symptoms onset,ECG ST-segment elevation with at least 2 contiguous ECG leads, >2 fold increase in cardiac enzymes. 18 years no limit Both previous history of ischemic heart disease left bundle branch block,paced rhythm,uninterpretable electrocardiogram,severe valvular disease,cardiomyopathy coronary anatomy unsuitable for angioplasty including those requiring coronary by-pass surgery or those candidate for medical treatment 121.0, 121 Acute myocardial infarction Treatment - Drugs N/A Intervention group: This group receive 20 milligram nicorandil tablet in Emergency room and another 20 milligram nicorandil in catheterization laboratory just before initiation of primary angioplasty.nicorandil tablets are made by Sanofi company.Nicorandil, a nicotinamide ester ,leads to relaxation of smooth tonic vascular muscles in both venous and arterial part of vessels via opening of potassium channel.Its major effect is vasodilation of coronary arteries and relief of ischemia. Control group: this group receives routine primary angioplasty and routine anti-ischemic drugs ST-segment resolution. Timepoint: 60 minutes after primary angioplasty. Method of measurement: Electrocardiogram. Left ventricular function. Timepoint: The day after primary angioplasty. Method of measurement: Echocardiography. Tabriz University of Medical Sciences Approved 2018-02-28 Ethics committee of Tabriz university of medical science Golgasht street-research deputy Tabriz East Azarbaijan Iran (Islamic Republic of)