Suxiao Jiuxin Pills in Microvascular Obstruction in Patients With Acute Coronary Syndrome

Last updated: March 22, 2021
Sponsor: Guangzhou University of Traditional Chinese Medicine
Overall Status: Active - Not Recruiting

Phase

4

Condition

Angina

Myocardial Ischemia

Coronary Artery Disease

Treatment

N/A

Clinical Study ID

NCT04814121
2020KT1715
  • Ages 18-75
  • All Genders

Study Summary

Microvascular obstruction is the severe complication of percutaneous coronary intervention (PCI) in patients with acute coronary syndrome. Microvascular obstruction after PCI is often association with poor prognosis. Current treatments do not show improvement in prognosis of microvascular obstruction. Suxiao Jiuxin Pills (SXJX) was shown associated with a reduction in MACE, and an improvement of heart function and quality of life in acute coronary syndrome (ACS) patients with early PCI. To evaluate the effectiveness and safety of SXJX in microvascular obstruction after PCI, the investigators designed this study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Meet the diagnosis of AMI, prepare for PCI reperfusion therapy;
  • Between the ages of 18-75;
  • Volunteer to participate in this study and have signed an informed consent form;
  • Have a correct understanding of the significance of drug research, and have a goodcompliance with the observation and evaluation.

Exclusion

Exclusion Criteria:

  • Not suitable for coronary intervention;
  • With unstable hemodynamics;
  • Platelet count<100×109;
  • Suspected aortic dissection or acute pulmonary embolism;
  • With mechanical complications;
  • With uncontrolled acute left heart failure and pulmonary edema;
  • With known bleeding history, active bleeding, bleeding constitution, or severehemostatic and coagulation dysfunction;
  • Meantain anticoagulants (such as warfarin or new anticoagulants);
  • Severe liver and kidney insufficiency (Child-Pugh B and above, Cr>177μmol/L (2mg/dl)or eGFR<45ml/min/1.73m2);
  • CTO, stent stenosis, or severe left main disease;
  • History of coronary artery bypass graft surgery;
  • Other pathophysiological conditions whose expected survival period is less than 1year;
  • Allergic history to Suxiao Jiuxin Pills;
  • Pregnant or lactating women;
  • Participating in other clinical studies;
  • With other diseases that are not suitable for participating in clinical research.

Study Design

Total Participants: 198
Study Start date:
May 01, 2021
Estimated Completion Date:
September 30, 2023