Comparing 24-Month Versus 12-Month Dual Antiplatelet Therapy After Drug-Eluting Stent Placement in Patients With High Lipoproteina Levels

What this Trial Is About

Researchers are studying patients with elevated Lipoproteina levels above 30 mgdL who have undergone percutaneous coronary intervention PCI with drug-eluting stent DES implantation but have not experienced cardiovascular events or significant bleeding within 12 months after the procedure. The trial aims to compare whether extending dual antiplatelet therapy DAPT from the standard 12 months to 24 months can reduce major adverse cardiovascular and cerebrovascular events such as death, heart attack, and stroke. This randomized, double-blind trial also evaluates if longer DAPT is as safe as the standard duration regarding bleeding and net adverse clinical events. Participants are randomly assigned to one of two groups one group receives aspirin combined with clopidogrel for 24 months after PCI, while the other group receives aspirin plus a placebo identical to clopidogrel for 12 months. The therapy is delivered as oral medications daily. The study includes a follow-up period with assessments at 3, 6, 9, and 12 months after randomization to monitor outcomes. The trial is conducted across multiple centers with blinded evaluation of results. During the study, participants will undergo regular monitoring to assess cardiovascular events and bleeding incidents, including all-cause death, myocardial infarction, stroke, stent thrombosis, and various bleeding types classified by the Bleeding Academic Research Consortium. Data will be collected through clinical visits and evaluations at predefined intervals up to 12 months after randomization. The research team will analyze these measures to determine the efficacy and safety of extended DAPT in this high-risk population. The total study duration includes treatment and follow-up phases to ensure comprehensive outcome assessment.

24 Versus 12-Month Dual Antiplatelet Therapy After Drug-Eluting Stent in Patients With Elevated Lipoprotein(a) Levels: A Prospective, Multicenter, Double-Blind, Placebo-Controlled Randomized Trial