Ticagrelor vs. Clopidogrel in Post PCI Patients
Condition: Stable Chronic Angina
MeSH terms: Angina, Stable
Study type: Interventional

Summary: 
      Elective PCI were included in the study. Patients were randomized into two different groups.
      One group took ASA 80 mg once daily and clopidogrel 75 mg once a day, and the other one took
      ASA 80 mg once a day and ticagrelor 90 mg twice a day. After six months of close follow-up,
      patients were asked to give a score to their dyspnea and asked about the major advance
      cardiovascular events ( MACE)
    

Detailed description: 
      Clinical data of this Randomized Clinical Trial (RCT) study was gathered from patients
      referred to Prof. Kojuri cardiovascular clinic (Shiraz, Iran, Email: kojurij@yahoo.com ,
      webpage: http://kojuriclinic.com/ ) from October 2022 to March 2023. The inclusion criterion
      was experiencing elective percutaneous coronary intervention (PCI). Patients diagnosed with
      hypersensitivity to either ticagrelor or clopidogrel or the ones having any other
      contraindications such as active pathological bleeding, were excluded from the study.
      Patients who consumed anticoagulants in the course of their medical therapy were also
      excluded.

      Basic clinical information of all patients such as diabetes mellitus (diagnosed based on ADA
      2018 criteria [23]), hypertension (defined as systolic blood pressure > 130 mmHg or diastolic
      blood > 80 mmHg based on 2017 ACC/AHA hypertension guideline [24]), dyslipidemia, anemia
      (defined according to 1968 Who definition [25]), asthma (diagnosed based on 2007 NAEPP
      criteria [26]) , chronic obstructive pulmonary disease (diagnosed according to 2020 GOLD
      criteria [27]), and atrial fibrillation (AF) were recorded. Furthermore, other clinical data
      such as body mass index (normal; 18.5 to 24.9, overweight; 25 to 29.9 and obesity; higher
      than 30), left ventricle ejection fracture (LVEF), and heart failure (classified based on
      2001 ACC/AHA heart failure classification [28]), history of using tobacco within the past 3
      months, and past drug history were also recorded. Major bleeding was defined according to the
      Thrombolysis in Myocardial Infarction (TIMI) criteria: intracranial bleeding, hemorrhage with
      a hemoglobin decrease of at least 5 g/dL, or fatal bleeding that caused death within 7 days
      [29].

      Patients were asked to give a score to their dyspnea based on the 10 point Likert scale
      before undergoing PCI. Score 1-3 were considered mild, score 4-7 were considered moderate,
      and score 7-10 were considered severe. Patients were randomized using the Block randomization
      method with block size=4 into two different groups. One group took acetylsalicylic acid (ASA)
      80 mg once daily and clopidogrel 75 mg that is produced by Sanofi company available in market
      as Plavix once a day, and the other one took ASA 80 mg once a day and ticagrelor 90 mg that
      is produced by Abidi company available in market as Brilavus twice a day.

      The patients were completely informed about the advantages and disadvantages of the study,
      and inform consents were taken from participants. Patients who desired not to participate
      were excluded from the study. Participants were told to take their medications regularly, and
      they were also encouraged to call us immediately if they faced any medical problem for
      further investigation.

      After six months of close follow-up, patients were asked to give a score to their dyspnea
      happened after PCI, based on the 10 point Likert scale. They were also asked about having
      dyspnea on exertion, paroxysmal nocturnal dyspnea (PND), any bleeding such as GI bleeding,
      and occurrence of major adverse cardiovascular event (MACE; defined as acute coronary
      syndrome (ACS), stroke, revascularization, hospitalization due to heart failure, and cardiac
      death.) [29] We followed the patients by using their phone numbers which were obtained at the
      beginning of the study.

      For statistical analyses we used IBM SPSS software version 25. Independent-sample t tests and
      one-way ANOVA were used for parametric variables. The Mann-Whitney U test and Kruskal-Wallis
      test were used for nonparametric data. Values of p <0.05 were considered significant.

      The study protocol was based on Helsinky declaration, all patients were filled the written
      consent, The study protocol was approved by Ethical committee of Shiraz University of medical
      sciences under the number of IR.SUMS.MED.REC.1401.351.
    

Intervention name(s): Clopidogrel; Ticagrelor
Intervention type(s): Drug; Drug
Intervention description(s): Treatment with dual antiplatelet drug,aspirin 80 mg PO daily with clopidogrel 75 mg PO daily; Treatment with dual antiplatelet drug,aspirin 80 mg PO daily with ticagrelor 90 mg PO twice daily
Intervention MeSH terms: Clopidogrel; Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: comparing two antiplatelet drugs , head to head, randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Percutaneous coronary intervention; dual antiplatelet therapy; major adverse cardiovascular event; P2Y12 inhibitor; ticagrelor; clopidogrel