Study of Single Antithrombotic Drug Treatment Using P2Y12 Inhibitors Followed by Oral Anticoagulants in Patients With Atrial Fibrillation After Supraflex Stent Implantation

What this Trial Is About

Patients with atrial fibrillation who undergo percutaneous coronary intervention PCI with stent implantation need different antithrombotic drugs to prevent stroke and heart complications. Current standard treatment includes three antithrombotic drugs for 1 week to 1 month, then two drugs for 6 to 12 months, followed by long-term treatment with one anticoagulant. Researchers are studying whether a single drug approach can reduce bleeding while still protecting against clotting events in a large trial of 3,010 patients. This study compares two treatment plans. One group takes a P2Y12 inhibitor alone for 1 month after stent placement, then switches to a direct-acting oral anticoagulant DOAC alone for 11 months. The other group follows standard care triple therapy aspirin, P2Y12 inhibitor, DOAC for up to 1 month, dual therapy P2Y12 inhibitor and DOAC for 6 to 12 months, and then DOAC alone. The study is randomized, open-label, and conducted across multiple sites internationally. Participants are monitored over 12 months with assessments of major cardiac or cerebral events like death, heart attack, stroke, and systemic embolism, as well as bleeding complications. Researchers will track hospitalizations, revascularizations, and detailed bleeding events using established criteria. After the study, patients receive routine care. The trial aims to find a safer, effective antithrombotic approach for atrial fibrillation patients after stent implantation.

Monotherapy With P2Y12 Inhibitors in Patients With Atrial fIbrillation Undergoing Supraflex Stent Implantation