Clinical Trial: The Effect of Dan-shen Extract On Lipoprotein Associated PHospholipase A2 Levels IN Patients With Stable Angina Pectoris

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized, Double-blind, Placebo-controlled Trial of Dan-shen Extract in Patients With Stable Angina Pectoris

Brief Summary: This is a randomized, double-blind, placebo-controlled, adaptive clinical trial, which will assess the effect of DanshenDuofensuanyan[Danshen (a kind of Chinese herbal drug) extract] treatment on Lipoprotein associated phospholipase A2 level in patients with stable angina pectoris.

Detailed Summary:
Sponsor: Taizhou Fourth People's Hospital

Current Primary Outcome: Serum level of Lp-PLA2 [ Time Frame: up to Day 60 after discharge ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The proportion of patients in each treatment group who had clinically significant change as defined by the angina-frequency score on the Seattle Angina Questionnaire [ Time Frame: Day 0 and Day 60 after discharge ]
  • carotid arterial intima-media wall thickness [ Time Frame: Day0 and Day 60 after discharge ]
  • Canadian Cardiovascular Society (CCS) grading of angina pectoris [ Time Frame: Day 0 and Day 60 after discharge ]
  • Change in the electrocardiogram (EKG) [ Time Frame: Day 0 and Day 60 after discharge ]
  • Changes in the Serum Lipid, the high-sensitivity C-Reactive Protein(hs-CRP) and the Platelet Aggregation Rate [ Time Frame: Day 0 and Day 60 after discharge ]
  • Incidence of new-onset major vascular events [ Time Frame: up to 60 days after discharge ]
    Major adverse vascular events include ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction and vascular-related death.
  • Incidence of severe hemorrhages [ Time Frame: up to 60 days after discharge ]
    The definition of "Severe hemorrhages" is in accordance with the GUSTO bleeding criteria, including fatal intracranial hemorrhage (ICH), symptomatic intracerebral hemorrhage (sICH) or which could result in substantial hemodynamic compromise requiring treatment.
  • Incidence of moderate hemorrhages [ Time Frame: up to 60 days after discharge ]
    The definition of "moderate hemorrhages" is in accordance with the GUSTO bleeding criteria, which requires blood transfusion but not results in hemodynamic compromise.


Original Secondary Outcome: Same as current

Information By: Taizhou Fourth People's Hospital

Dates:
Date Received: August 13, 2016
Date Started: September 2016
Date Completion: August 2017
Last Updated: September 11, 2016
Last Verified: September 2016