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Effect of Xinyue capsules on patients with coronary heart disease after percutaneous coronary intervention: study

Ming Guo1, Ming-Jie Zi1, Rui-Xi Xi1,2

  • 1Cardiovascular Diseases Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, 1 Xiyuan Caochang, Haidian District, Beijing, 100091, China.

Trials
|August 20, 2016
PubMed

Insights

This clinical trial investigates Xinyue capsules for coronary heart disease (CHD) patients post-percutaneous coronary intervention (PCI). It assesses if this Chinese herbal medicine reduces major adverse cardiovascular events, offering new treatment evidence.

Area of Science:

  • Cardiovascular Medicine
  • Pharmacology
  • Integrative Medicine

Background:

  • High risk of cardiovascular events persists in coronary heart disease (CHD) patients after percutaneous coronary intervention (PCI).
  • Panax quinquefolius saponin, a key component of Xinyue capsule, is traditionally used for CHD.
  • Xinyue capsule's efficacy and safety in this patient group require rigorous evaluation.

Purpose of the Study:

  • To evaluate the efficacy and safety of Xinyue capsules in patients with CHD following PCI.
  • To determine the impact of Xinyue capsules on major adverse cardiovascular events.
  • To provide evidence for Chinese herbal medicine in managing post-PCI CHD.

Main Methods:

  • Multicenter, placebo-controlled, double-blind, randomized clinical trial.
  • 1100 participants randomized to Xinyue capsules or placebo with conventional treatment for 24 weeks.
  • Primary outcome: time to first major adverse cardiovascular event; secondary outcomes: stroke, embolism, vascular events, and all-cause death.

Main Results:

  • Primary outcome data on major adverse cardiovascular events will be analyzed.
  • Secondary outcome data on specific cardiovascular events and mortality will be assessed.
  • Adverse events will be monitored throughout the 48-week follow-up period.

Conclusions:

  • The study aims to provide critical evidence on the role of Xinyue capsules in managing CHD patients post-PCI.
  • Results will inform the use of Chinese herbal medicine in cardiovascular care.
  • The trial's findings will contribute to understanding novel therapeutic strategies for post-procedural cardiovascular risk.
Abstract

Keywords:
Coronary heart diseaseRandomized controlled trialXinyue capsule

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