Danhong Injection in the Treatment of Unstable Angina Pectoris

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

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

Conditions
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Unstable Angina Pectoris

Intervention / Treatment
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* Drug: Danhong injection
* Other: Standard medical care
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female or male inpatients. Age: 35 - 75 years. Patients with clinical diagnosis of unstable stable angina according to 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, including one of the following conditions. Clinical diagnosis of Xueyu Zheng (Blood Stasis Syndrome) as the scores of Chinese medicine symptoms scales of Xueyu Zheng in UA ≥ 15. The Chinese medicine symptoms scales of Xueyu Zheng is a 6-item questionnaire including the symtoms as following: (1)chest pain-10, (2)chest distress-10, (3) palpitation-5, (4)purple or dark lip-5, (5) purple or dark tongue-5, (6) unsmooth pulse-5. Patient is willing to participate voluntarily and to sign a written patient informed consent. Exclusion Criteria: Patients with severe heart failure (EF<35%); Patients with history of infection, fever, trauma, surgery(exclude PCI) and inflammation in the past month; Patients with active tuberculosis or rheumatological disorders; Patients with renal dysfunction (Male: CCr>2.5mg/dl; Female: CCr>2.0mg/dl); Patients with liver dysfunction (any value of serum aminotransferase more than triple normal value); Patients with history of hematopoietic system diseases; Patients with mental disorder; Patients with history of drug-induced bleeding or history of bleeding caused by warfarin; Patients with malignant tumor; Patients with history of organ transplant; Woman with pregnancy, lactation or positive result of pregnancy test; Patients who is participating in other trials or has been participated in other trials in recent 3 months; Patients who were unable to participate in the study as judged by investigator.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Danhong injection<br>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<br>* A kind of injection made from two kind of Chinese herbs: salvia miltiorrhiza and safflower<br>Other: Standard medical care<br>* 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<br>|
| Placebo Comparator: Placebo<br>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<br>* 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<br>Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of the Quantification score of angina pectoris at 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. | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total score of symptoms questionnaire of TCM | 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. | Day 0, Day 7 | 
| Use of Short-acting Nitrates |  | Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 28 | 
| Change in the electrocardiogram (ECG) | 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. | Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 28 | 
| The proportion of patients who are undergoing PCI |  | Day 7, Day 28 | 
| Change in Seattle Angina Questionnaire | 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. | Day 0, Day 28 | 
| Incidence of adverse events (including serious adverse events) in 28 days |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unstable Angina Pectoris, Randomized Controlled Trial, Traditional Chinese Medicine