The aim of TRUST study is to assess the clinical efficacy & safety, and define the optimum dosing of Myogrel (an Egyptian well known Clopidogrel) in terms of reducing stent thrombosis & other major adverse cardiovascular events in patients undergoing elective PCI with bare metal stent insertion, and referring these results to those of the international studies on the reference Clopidogrel brand.
METHODS
TRUST study is a prospective, observational, multicenter open label study in which 374 Egyptian patients with a history of myocardial ischemia (angina or myocardial infarction) were enrolled in cath labs to undergo elective PCI with bare metal stent insertion. Patients received a loading dose of 600 mg Myogrel at least 2 hours before the procedure, then distributed in 2 arms; First arm (standard dose): Patients received 75 mg Myogrel once daily (along with ASA 75-325 mg daily) for 3 months. Second arm (high dose): Patients received 150 mg Myogrel once daily for six days, followed by 75 mg Myogrel once daily (along with ASA 75-325 mg daily) for the rest of 3 months. The primary end point was stent thrombosis, while the secondary end points were myocardial infarction, need for target vessel revascularization (TVR) & cardiovascular death. In addition, drug adverse events, including the incidence of bleeding, were recorded.
RESULTS
369 patients completed the study, with 207 patients in the 1st arm & 162 patients in the 2nd arm. Such patient population included different genders (76% males), age groups (mean; 58 years), risk factors & target vessels (60% with LAD). In addition, stents inserted were varying in their numbers (mean; 1.25 stent per case), lengths (mean; 15.9 mm) & diameters (mean; 2.5 mm) between individual patients. Through the 3 months follow up period, Myogrel led to zero incidences of the primary end point; stent thrombosis & secondary end points; myocardial infarction, need for target vessel revascularization (TVR) & cardiovascular death, with 2% incidence of minor bleeding events (2.4% in 1st arm & 1.9% in 2nd arm).
CONCLUSION
In a wide variety of Egyptian patients undergoing elective PCI with bare metal stent insertion (with different genders, age groups, risk factors, target vessels, and numbers, lengths & diameters of inserted stents) Myogrel, taken by standard or high dose regimens, was proven to be clinically effective & safe, compared to the known results about the reference Clopidogrel, in reducing the risks of stent thrombosis & other major adverse cardiovascular events.
|
