Study Protocol: Qing-Xin-Jie-Yu Granules for Coronary Artery Disease
Introduction
Managing stable coronary artery disease (SCAD) is challenging despite available treatments. Intermediate coronary lesion (ICL) is a critical stage of SCAD, but current therapies have limitations. Qing-Xin-Jie-Yu Granules (QXJYG) may offer benefits as a complementary therapy due to its anti-platelet, anti-inflammatory, and lipid-lowering effects.
Materials and Methods
This is a multicenter, randomized, double-blind, placebo-controlled trial involving 120 participants with ICL. The primary goal is to investigate the efficacy and safety of QXJYG in treating ICL, focusing on its impact on myocardial ischemia and plaque progression. Participants will receive QXJYG or a placebo for 6 months, followed by a 12-month follow-up. Various outcomes will be measured, including computed tomography-derived fractional flow reserve, coronary stenosis, Gensini score, and safety outcomes such as bleeding events and adverse events.
Discussion
This trial aims to provide reliable results on the efficacy and safety of QXJYG in treating ICL, offering new insights to address the therapeutic challenges of ICL and SCAD management.
Trial Registration
Registered on the Chinese Clinical Trial Registry (ChiCTR2200059262) on April 27, 2022.
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