Study Design and Ethics
This study was a prospective, double-blind, randomized controlled clinical trial that was conducted on 264 patients with STEMI who underwent PPCI. The sample size of this study was (calculated based on statistical formulas and after 10% downfall), 264 people. All these patients were treated similarly with aspirin (300 mg), clopidogrel (600 mg) and statin after electrocardiographic confirmation of STEMI. Then all patients underwent PPCI. Regarding the angiography method, femoral approach was preferred. All patients received the same dose of intravenous heparin and bolus dose of eptifibatide (180 µg/kg/10 min). Then the patients were randomly divided into two groups, one group (n=147) received a maintenance dose of intravenous eptifibatide (infusion of 2µg/kg/min) and the other group (n=117) did not receive this treatment. Randomization was done by sealed envelopes at the end of the procedure. Administering the maintenance dose of eptifibatide started during the first hour after the bolus dose injection and continued for 12 hours. Standard medical treatment of ACS after PCI was performed based on guidelines and the same in both groups with aspirin (80 mg), clopidogrel (75 mg), lipid-lowering drugs, beta-blockers and angiotensin-converting enzyme inhibitors (ACEIs) or Angiotensin receptor blockers (ARBs). (9, 10). All patients were re-evaluated 1 and 3 months after the start of treatment in terms of predicted outcomes.
Also, the objectives of this research project and its implementation method were explained to all patients, and they entered this project after obtaining oral and written informed consent. It should be noted that this study was registered and approved by the Ethics Committee of Mazandaran University of Medical Sciences before its implementation.