A randomized, double-blind, placebo-controlled trial to assess the efficAcy and safety of Trimetazidine in patients with angina pectoris having been treated by percutaneous coronary intervention (ATPCI study): Rationale, design, and baseline characteristics
Abstrakt
BACKGROUND: About 30% of angina patients have persisting symptoms despite successful revascularization and antianginal therapy. Moreover, in stable patients, percutaneous coronary intervention (PCI) does not improve survival as compared with medical therapy alone.
Trimetazidine, an antianginal agent devoid of hemodynamic effect, may help reducing symptoms and improving outcomes after PCI. The ATPCI study is investigating the efficacy and safety of adding trimetazidine to standard-of-care in angina patients who had a recent PCI.
METHODS: ATPCI is a randomized, double-blind, parallel-group, placebo-controlled, event-driven study in patients with coronary artery disease having undergone PCI because of stable angina (elective PCI) or unstable angina/NSTEMI (urgent PCI). After PCI, patients were randomized to trimetazidine (35 mg bid) or placebo on top of standard-of-care including event prevention drugs and antianginal treatment.
Patients will be followed for 2 to 4 years. The primary efficacy endpoint is a composite of cardiac death, hospitalization for a cardiac event and recurrence or persistence of angina.
Safety events related to trimetazidine use will be monitored. RESULTS: Recruitment lasted from September 2014 to June 2016.
A total of 6007 patients were enrolled (58% and 42% after elective and urgent PCI, respectively). Mean age was 61 years, 77% were males, and median durations of coronary artery disease were 1 and 5 months (if urgent or elective PCI, respectively).
Almost all patients received drugs for event prevention and antianginal therapy at baseline. CONCLUSION: The ATPCI study will shed further light on the management of contemporary angina patients after PCI.
Results are expected in 2019.