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IRCT20120111008698N24 IRCT 2019-08-02 Tehran University of Medical Sciences Evaluating the role of intravenous pentoxifylline on successfullness of stenting in patients with myocardial infarction PENTOS Evaluating the role of intravenous Pentoxifylline administration on increasing primary percutaneous coronary intervention (PPCI) success in ST elevation myocardial infarction (STEMI) patient 2019-06-20 anticipated 320 Complete https://irct.ir/trial/34950 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, Permuted Block randomization method was used individually. The randomized list of numbers 1 to 320 is randomly divided into two groups A or B, and the admitted patients are listed in group A or B, respectively, Blinding description: In this study, researchers and data analysers are unaware of the allocation of study groups, and those who prepare a draft article are also kept blind to the allocation of blind study groups Patients in group A or B and receiving a drug or placebo by the patient are unaware. N/A Acute myocardial infarction. Intervention 1: Intervention group: Administration of intravenous pentoxifylline; 50 mg IV bolus, then 50 mg IV infusion in 30 minutes. Intervention 2: Control group: Administration of solvent: NaCl 0.9 % serum. Yes - There is a plan to make this available What will be shared: Data such as primary and secondary outcome information When: Start the access period 6 months after printing the results To whom: For researchers working in academic and scientific institutions Conditions: Conditions for using the data or documentation will be determined depending on the type of use, with the coordinator of the project Where to obtain: E-mail: a-talasaz@tums.ac.ir How to obtain: E-mail: a-talasaz@tums.ac.ir Comments:
public Dr. Hessam Kakavand
Pharmacotherapy Department, Faculty of Pharmacy, Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) 88029731 +98 21 8802 9261 hessamkakavand@yahoo.com Tehran University of Medical Sciences scientific Dr Azita Hajhossein Talasaz
Pharmacotherapy Department, Faculty of Pharmacy, Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) 88029731 +98 21 2260 6951 atalasaz@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients older than 18 who are candidate for primary PCI. Pain or chest discomfort greater than or equal to 20 minutes, less than or equal to 12 hours, and ST elevation ≥ 1 mm in the adjacent limb leads and precordial leads except for V2, V3, or ST elevation ≥ 2 mm in V2, V3 in men or ST height ≥ 1.5 mm in V2, V3 in women. Obtain informed consent from all patients before enrollment. 18 years no limit Both Start angina more than 12 hours CPR before transition to cath-lab Patients with history of cardiac transplantation Patients with history of PCI or CABG in last month Patients who received thrombolytic Current use of pentoxyfilline Use of ketorolac in last 24 hours I21 ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction Treatment - Drugs Placebo Intervention group: Administration of intravenous pentoxifylline; 50 mg IV bolus, then 50 mg IV infusion in 30 minutes Control group: Administration of solvent: NaCl 0.9 % serum Coronary blood flow and myocardial perfusion. Timepoint: during angiography. Method of measurement: TIMI flow criteria and observations during the angiography. Hs-CRP. Timepoint: baseline and 48 hours after PCI. Method of measurement: blood sample. TNT. Timepoint: baseline and 24 hours and 48 hours after PCI. Method of measurement: blood sample. 30 day MACE. Timepoint: one month after PCI. Method of measurement: follow-up visit or phone call. TFC. Timepoint: during angiography. Method of measurement: TIMI frame count and observations during the angiography. MBG. Timepoint: during angiography. Method of measurement: myocardial blush grade and observations during the angiography. Tehran University of Medical Sciences Approved 2018-03-10 Ethics committee of Tehran University of Medical Sciences Tehran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)