World Journal of
Pharmaceutical and Life Sciences

A CLINICAL TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF TICAGRELOR IN BANGLADESHI PATIENTS UNDERGOING PRIMARY PERCUTANEOUS CORONARY INTERVENTION (PCI) [GLORIOUS 2 TRIAL]

*Dr. S. M. Mamun Iqbal, Dr. Syed Muhammad Baqui Billah, Dr. Kasekh Akhtar Jahan, Saifur Rahman, Dr. Nahid Sultana and Dr. Mohammed Zahidul Alam

ABSTRACT

Background: In several clinical trials, Ticagrelor was superior to Clopidogrel in reducing cardiovascular events among patients with Acute Coronary Syndrome (ACS). We evaluated the safety and efficacy of Ticagrelor in Bangladeshi patients undergoing Primary Percutaneous Coronary Intervention (PCI). Methods: Applying the inclusion and exclusion criteria, patients were allocated to Ticagrelor group [Tablet Ticagrelor 180 mg loading followed by 90 mg twice daily maintenance dose for 12 months] or to Clopidogrel group [Tablet Clopidogrel 600mg loading followed by 75mg daily maintenance dose for 12 months]. After PCI, the patients were followed up for 12 months .The primary endpoint of efficacy (death, myocardial infarction [MI] and stroke), and safety (bleeding, and dyspnea) were evaluated and compared between the two groups. Results: 111 patients with ST- Elevation Myocardial Infarction (STEMI) were recruited and 61 patients were assigned to Ticagrelor group and 51 patients to Clopidogrel group. The primary endpoint occurred in fewer patients in Ticagrelor group than in Clopidogrel group (9.8% in Clopidogrel and 5% in Ticagrelor group; p= 0.18). There was significant increase in the incidence of side effects in Ticagrelor group ( minor bleeding occurred in no patient in Clopidogrel and 1.7% of patients in Ticagrelor group , and dyspnea occurred in 2.0% of patients in the Clopidogrel group and 13.3% of patients in Ticagrelor group; p= 0.04). Conclusion: Ticagrelor numerically reduced the risk of death in patients undergoing primary PCI, but the incidence of minor bleeding and dyspnea were significantly more with Ticagrelor compared to Clopidogrel in Bangladeshi patients.

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