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IRCT20161026030511N3 IRCT 2018-12-23 Samin Daroo Company Efficacy of Ranolazine in reduction of blood sugar in type 2 diabetic patients with ischemic heart disease Efficacy and safety endpoints of Ranolazine in comparison with conventional therapy in reduction of HbA1c percentage in type 2 diabetic patients with ischemic heart disease 2016-06-21 anticipated 60 Complete https://irct.ir/trial/24223 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 Condition 1: Diabetes mellitus. Condition 2: Stable angina. Intervention 1: intervention group: treatment with Ranolazine (Ranexa) 1000 mg orally 2 times a day for 8 weeks. Intervention 2: Control group: continued their conventional therapy Nitroglycerin 2.6 mg orally twice a day. Yes - There is a plan to make this available What will be shared: The data will be sent by email to those who are interested after the article published When: 6 month after publishing the article To whom: Pharmacists and medical doctors Conditions: Only for continue the researches which is suggested in the article Where to obtain: Dr Farsad, Rajaie cardiovascular, medical and research center How to obtain: send request by email Comments: not available
public Bahram Fariborz Farsad
Valiasr Ave., Niayesh Intersection
Tehran Iran (Islamic Republic of) 1991953381 +98 21 2266 3310 ffarsad@yahoo.com Rajaie cardiovascular, medical and research center scientific Bahram Fariborz Farsad
Valiasr Ave., Niayesh Intersection
Tehran Iran (Islamic Republic of) 1991953381 +98 21 2266 3310 ffarsad@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) HbA1c more than 6.5%, Age more than 50 year, both genders with diabetes mellitus and coronary artery disease (CAD) Experiencing chronic stable angina for at least 3 months triggered by physical effort and relieved by rest and/or sublingual nitroglycerin CAD documented by one or more of the following: Angiography evidence of more than 50% stenosis of one or more coronary arteries, History of MI, cardiac imaging or exercise test diagnostic for CAD Treatment with up to 2 anti-anginal therapies at a stable dose for at least 2 weeks before starting the trial T2DM patients who use Metformin and Gliclazide 50 years no limit Both New York Heart Association class III and IV Acute coronary syndrome in the prior 2 months or planned for coronary revascularization Stroke or transient ischemic attack within 6 months prior QTc more than 500 ms Systolic blood pressure more than 180, diastolic blood pressure more than 110 mmHg Liver cirrhosis Prior treatment with CYP 3A4 inhibitors or P GlyP inductors Treatment with anti arrhythmic medicine class ll and lll Alcohol consumption or drug users Simvastatin consumption E11.0 I20.8 Type 2 diabetes mellitus with hyperosmolarity Other forms of angina pectoris Treatment - Drugs Treatment - Drugs intervention group: treatment with Ranolazine (Ranexa) 1000 mg orally 2 times a day for 8 weeks Control group: continued their conventional therapy Nitroglycerin 2.6 mg orally twice a day Percentage of HbA1c. Timepoint: Per month. Method of measurement: Blood test Hitachi 911 automatic analyzer. Reduction of using sublingual nitroglycerin per week. Timepoint: Weekly. Method of measurement: Patient report. Samin Daroo Company Approved 2015-11-30 ٍEthics committee of Shahid Beheshti University of Medical Sciences Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences, Valiasr Ave. Tehran Tehran Iran (Islamic Republic of)