Danhong Injection in the Treatment of Unstable Angina Pectoris
|ClinicalTrials.gov Identifier: NCT02007187|
Recruitment Status : Completed
First Posted : December 10, 2013
Last Update Posted : December 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Unstable Angina Pectoris||Drug: Danhong injection Other: Standard medical care Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-blind, Multicenter, Parallel Controlled Clinical Trial of Danhong Injection in the Treatment of Unstable Angina Pectoris|
|Actual Study Start Date :||December 2013|
|Actual Primary Completion Date :||August 2017|
|Actual Study Completion Date :||November 2017|
Experimental: Danhong injection
Based on the standard medical care, 40ml of Danhong injection, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2-3 hours every day for 7 days.
Drug: Danhong injection
A kind of injection made from two kind of Chinese herbs: salvia miltiorrhiza and safflowerOther: Standard medical care
Standard medical care is in accordance with China Guideline for the diagnosis and treatment of unstable angina (UA) and non-ST-elevation myocardial infarction (NSTEMI) (2007) issued by Chinese Society of Cardiology of Chinese Medical Association
Placebo Comparator: Placebo
Based on the standard medical care, placebo was 40ml of 0.9% saline, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2-3 hours every day for 7 days.
Other: Standard medical care
Standard medical care is in accordance with China Guideline for the diagnosis and treatment of unstable angina (UA) and non-ST-elevation myocardial infarction (NSTEMI) (2007) issued by Chinese Society of Cardiology of Chinese Medical AssociationDrug: Placebo
0.9% saline added into 250ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, using brown infusion tube for infusion.
- 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.
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02007187
|Beijing, Beijing, China, 100053|
|Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine|
|Beijing, Beijing, China, 100700|
|The First Affiliated Hospital of Guangzhou University of Chinese Medicine|
|Guangzhou, Guangdong, China, 510405|
|The First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine|
|Ha'erbin, Heilongjiang, China, 150040|
|Zhengzhou No.7 People's Hospital|
|Zhengzhou, Henan, China, 450006|
|The First Hospital of Changsha|
|Changsha, Hunan, China, 410005|
|The Affiliated Hospital to Changchun University of Chinese Medicine|
|Changchun, Jilin, China, 130021|
|Hospital 463 of P.L.A.|
|Shenyang, Liaoning, China, 110046|
|First Teaching Hospital of Tianjin University of T.C.M.|
|Tianjin, Tianjin, China, 300193|
|Principal Investigator:||Zhong Wang, M.D., Ph.D.||Institute of Basic Research in Clinical Medicine，China Academy of Chinese Medical Sciences|
|Principal Investigator:||Xian Wang, M.D.||Dongzhimen Hospital, Beijing|
|Study Director:||Xiao-xi Du, Professor||China Food and Drug Administration|