Clinical Trial: Danhong Injection in the Treatment of Unstable Angina Pectoris

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

Official Title: A Randomized, Double-blind, Multicenter, Parallel Controlled Clinical Trial of Danhong Injection in the Treatment of Unstable Angina Pectoris

Brief Summary: The purpose of this study is to determine the efficacy and safety of Danhong injection in the treatment of unstable angina pectoris.

Detailed Summary:
Sponsor: China Academy of Chinese Medical Sciences

Current Primary Outcome: Change from baseline of the Quantification score of angina pectoris at Day 7 [ Time Frame: Day 7 ]

Quantification score of angina pectoris is a 4-item questionnaire that quantifies the frequency of angina, the duration of angina at every attack, the severity of angina and the use of nitroglycerin in a week. Scores range from 0 to 24; higher scores indicate worse health status.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Total score of symptoms questionnaire of TCM [ Time Frame: Day 0, Day 7 ]
    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.
  • Use of Short-acting Nitrates [ Time Frame: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 28 ]
  • Change in the electrocardiogram (ECG) [ Time Frame: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 28 ]
    ECG will be done five times every day, when 5-10 min before use of nitrates or Danhong injection, 5-10 min after use of nitrates or Danhong injection, at the time 22:00. If there is an angina attack, an additional ECG should be done when the angina attacks.
  • The proportion of patients who are undergoing PCI [ Time Frame: Day 7, Day 28 ]
  • Change in Seattle Angina Questionnaire [ Time Frame: Day 0, Day 28 ]
    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.
  • Incidence of adverse events (including serious adverse events) in 28 days [ Time Frame: 28 days ]


Original Secondary Outcome: Same as current

Information By: China Academy of Chinese Medical Sciences

Dates:
Date Received: December 5, 2013
Date Started: December 2013
Date Completion:
Last Updated: October 9, 2016
Last Verified: October 2016