Clinical Trial: Danhong Injection in the Treatment of Chronic Stable Angina

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Multi-center, Double-blind, Placebo-controlled Trial of Danhong Injection in the Treatment of Chronic Stable Angina

Brief Summary: The purpose of this study is to evaluate the effect of Danhong Injection on the relief of angina with the use of the Seattle Angina Questionnaire among patients with stable angina patients

Detailed Summary:
Sponsor: China Academy of Chinese Medical Sciences

Current Primary 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 at day 30 [ Time Frame: Day 30 ]

Seattle Angina Questionnaire, a 19-item questionnaire that quantifies physical limitations due to angina, any recent change in the severity of angina, the frequency of angina, satisfaction with treatment, and quality of life. Scores range from 0 to 100; higher scores indicate better health status.With a score of 20 or more on the angina-frequency scale indicating that the patient was clinically significant change.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Total score of symptoms questionnaire of TCM [ Time Frame: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90 ]
    The symptoms questionnaire of TCM consists of 6 symptoms that described in traditional Chinese medicine, including chest pain, chest distress, palpitation, dark-purple lip, dark-purple tongue and unsmooth pulse. Each symptom was assessed by the Visual Analogue Scale（VAS），where a higher score meant higher severity.
  • The proportion of patients in each treatment group who had clinically significant changes in the other four Seattle Angina Questionnaire scales （The physical limitation, angina stability, treatment satisfaction, and quality of life） [ Time Frame: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90 ]
    We defined clinical significant changes as a difference of 8 points or more on the physical-limitation scale, 25 or more on the angina-stability scale, 12 or more on the treatment-satisfaction scale, or 16 or more on the quality-of-life scale.
  • The frequency of anginal attack every week [ Time Frame: Day-7 (if exist), Day 0, Day 7, Day 14, Day 30, Day 60, Day 90 ]
    The frequency of anginal attack was recorded by the patients with the use of the diary cards which will be collected from the run-in period (Day -7) to the end of follow-up (Day 90).
  • Canadian Cardiovascular Society (CCS) grading of angina pectoris [ Time Frame: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90 ]
  • Consumption of Short-acting Nitrates [ Time Frame: Day -7( if exist), Day 0, Day 7, Day 14, Day 30, Day 60, Day 90 ]
  • Change in the electrocardiogram (EKG) [ Time Frame: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90 ]
  • Changes in the Serum Lipid, the high-sensitivity C-Reactive Protein(hs-CRP) and the Platelet Aggregation Rate [ Time Frame: Day 0, Day 14 ]
  • Incidence of new-onset major vascular events in 90 days [ Time Frame: Day 90 ]
    Major adverse vascular events include ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction and vascular-related death.
  • Overall mortality in 90 days [ Time Frame: Day 90 ]
  • Incidence of severe hemorrhages in 90 days [ Time Frame: Day 90 ]
    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 in 90 days [ Time Frame: Day 90 ]
    The definition of "moderate hemorrhages" is in accordance with the GUSTO bleeding criteria, which requires blood transfusion but not results in hemodynamic compromise.
  • Documentation of adverse events (AEs) and serious AEs [ Time Frame: 90 days ]


Original Secondary Outcome: Same as current

Information By: China Academy of Chinese Medical Sciences

Dates:
Date Received: September 5, 2012
Date Started: December 2012
Date Completion:
Last Updated: October 11, 2016
Last Verified: October 2016