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.