Danhong Injection in the Treatment of Chronic Stable Angina

China Academy of Chinese Medical Sciences

Status and phase: Completed; Phase 4

Conditions: Chronic Stable Angina

Treatments: Drug: Danhong injection; Drug: Placebo; Other: Standard medical care

Study type: Interventional

Funder types: Other

Identifiers

NCT01681316

DH20120703

Details and patient eligibility

About

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

Enrollment: 920 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female or male inpatients.
• Age: 18 - 70 years.
• Patients with clinical diagnosis of chronic stable angina and must meet one of the following conditions:1）Patients who have a history of myocardial infarction and ST-T changes;2）Stenosis of more than 50% in at least one major epicardial coronary artery shown by Coronary Angiograph or CT Angiography; 3）Patients with coronary heart disease were determined by radionuclide angiocardiography.
• Clinical diagnosis of "Xueyu Zheng" (Blood Stasis Syndrome) as the scores of Chinese medicine symptoms scales of "Xueyu Zheng" in angina ≥ 15. The Chinese medicine symptoms scales of "Xueyu Zheng" is defined 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.
• Patients with moderate angina pectoris (The definition of "moderate angina pectoris " is in accordance with the Canadian Cardiovascular Society (CCS) grading of angina pectoris,which be classified to II or III.
• Patient is willing to participate voluntarily and to sign a written patient informed consent.

Exclusion criteria

• Woman with pregnancy, lactation or positive result of pregnancy test, or woman who is under menstrual period.
• Woman who disagree with contraception during treatment period
• Patients with severe complications that would make the condition more complicated assessed by the investigator, including liver or renal dysfunction, severe cardiopulmonary dysfunction, pulmonary hypertension, chronic obstructive pulmonary disease, a history of epilepsy or cerebral hemorrhage .
• Patients who were angina-free during the run-in period without taking any drug.
• Patients with myocardial infarction or Canadian Cardiovascular Society (CCS) grading of angina pectoris class IV within the preceding 3 months
• Patients with chest pain caused by other disease (e.g., acute myocardial infarction，severe neurosis，menopausal syndrome，hyperthyroidism).
• Patients with history of drug-induced bleeding or history of bleeding caused by warfarin.
• Patients with history of hematopoietic system diseases.
• Patients who had surgery within the past 4 weeks and have hemorrhagic tendency.
• Patients who is participating in other trials or has been participated in other trials in recent 3 months.
• Patients with history of allergy or suspected allergic to the drug.
• Patients who were suspected addicted into alcohol or drug abuse in the past 2 years.
• Patients with mental disorder.
• Patients who were unable to participate in the study as judged by investigator.
• Patients who were family members or relatives of the research center staffs.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

920 participants in 2 patient groups, including a placebo group

Danhong injection

Experimental group

Description:

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 hours.

Treatment:

Drug: Danhong injection

Other: Standard medical care

Placebo

Placebo Comparator group

Description:

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 hours.

Treatment:

Drug: Placebo

Other: Standard medical care