Danhong Injection in the Treatment of Unstable Angina Pectoris

China Academy of Chinese Medical Sciences

Status and phase: Completed; Phase 4

Conditions: Unstable Angina Pectoris

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02007187

2011ZX09304-07V1.2

Details and patient eligibility

About

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

Enrollment: 160 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 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 2-3 hours every day for 7 days.

Treatment:

Other: Standard medical care

Drug: Danhong injection

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 2-3 hours every day for 7 days.

Treatment:

Other: Standard medical care

Drug: Placebo