Danhong Injection in the Treatment of Unstable Angina Pectoris

Unstable Angina Pectoris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02007187
• Other study ID #: 2011ZX09304-07V1.2
• Status: Completed
• Phase: Phase 4
• First received: December 5, 2013
• Last updated: November 29, 2017
• Start date: December 2013
• Est. completion date: November 2017

Study information

• Verified date: November 2017
• Source: China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: November 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Unstable
• Unstable Angina Pectoris

Intervention

Drug:
• Danhong injection
A kind of injection made from two kind of Chinese herbs: salvia miltiorrhiza and safflower

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 Association

Drug:
• 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.

Locations

Country	Name	City	State
China	Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine	Beijing	Beijing
China	Xuanwu Hospital	Beijing	Beijing
China	The Affiliated Hospital to Changchun University of Chinese Medicine	Changchun	Jilin
China	The First Hospital of Changsha	Changsha	Hunan
China	The First Affiliated Hospital of Guangzhou University of Chinese Medicine	Guangzhou	Guangdong
China	The First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine	Ha'erbin	Heilongjiang
China	Hospital 463 of P.L.A.	Shenyang	Liaoning
China	First Teaching Hospital of Tianjin University of T.C.M.	Tianjin	Tianjin
China	Zhengzhou No.7 People's Hospital	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
China Academy of Chinese Medical Sciences	China Food and Drug Administration

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Use of Short-acting Nitrates		Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 28
Secondary	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
Secondary	The proportion of patients who are undergoing PCI		Day 7, Day 28
Secondary	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
Secondary	Incidence of adverse events (including serious adverse events) in 28 days		28 days