2. Methods
bleeding, dyspnea, stroke, diabetes mellitus, cardiac death, ACS
BLEEDING, STROKE, GASTROINTESTINAL BLEEDING, DIABETES MELLITUS, CARDIAC DEATH, PAROXYSMAL NOCTURNAL DYSPNEA, PND, ACUTE CORONARY SYNDROME, HEART FAILURE, COMPLICATIONS
We gathered clinical data for this Randomized Clinical Trial (RCT) study from patients referring to Professor Kojuri's Cardiovascular Clinic (Shiraz, Iran, e-mail: Basic clinical information of all patients and comorbidities such as diabetes mellitus (diagnosed based on ADA 2018 criteria [Patients scored their dyspnea on a 10-point Likert scale before undergoing PCI. Scores 1–3 were mild, 4–6 were moderate, and 7–10 were severe. We randomized patients using the block randomization method with a block size = 4 into two groups. One group received acetylsalicylic acid (ASA) 80 mg daily and clopidogrel 75 mg daily (Sanofi Co.; brand name: Plavix) and the other received ASA 80 mg daily and ticagrelor 90 mg twice daily (Abidi Co.; brand name: Brilavus).We thoroughly explained the study objectives and protocols to the patients and obtained informed consent, excluding those who did not wish to participate. We asked the participants to take their medications regularly and call us immediately if they faced any medical problems for further investigation. To check drug compliance and complications, we followed up on the patients via monthly phone calls and in-person visits after one, three, and six months of starting medications.After six months of close follow-up, patients scored their post-PCI dyspnea on the 10-point Likert scale. We also asked them about dyspnea on exertion, paroxysmal nocturnal dyspnea (PND), bleeding (e.g., gastrointestinal bleeding), and MACEs, defined as an acute coronary syndrome (ACS), stroke, revascularization, hospitalization due to heart failure, or cardiac death [For statistical analysis, we used IBM SPSS software version 25. To analyze the study data, we used the intention-to-treat method. As a result, patients were included in the analysis based on the originally assigned group, regardless of the received medication. We summarized data with a normal distribution using the mean ± standard deviation. We also reported the variables' odds ratio (OR) and 95% confidence interval (CI). Independent-sample The Ethics Committee of Shiraz University of Medical Sciences approved the study protocol (IR.SUMS.MED.REC.1401.351).