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NCT Number: NCT01681316

Danhong Injection in the Treatment of Chronic Stable Angina

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

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Key information

Conditions

Chronic Stable Angina Angina Pectoris Angina, Stable Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chinese PLA General Hospital(301 Hospital), Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Danhong injection

Drug

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

Standard Medical Care

Other

Standard medical care is in accordance with China Guideline for the diagnosis and treatment of Chronic Stable Angina (2007).

Placebo

Drug

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.

Primary outcomes

  1. The proportion of patients in each treatment group who had clinically significant change as defined by the angina-frequency score on the Seattle Angina Questionnaire at day 30

    Time frame: Day 30

    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.

Secondary outcomes

  1. Total score of symptoms questionnaire of TCM

    Time frame: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90

    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.

  2. The proportion of patients in each treatment group who had clinically significant changes in the other four Seattle Angina Questionnaire scales （The physical limitation, angina stability, treatment satisfaction, and quality of life）

    Time frame: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90

    We defined clinical significant changes as a difference of 8 points or more on the physical-limitation scale, 25 or more on the angina-stability scale, 12 or more on the treatment-satisfaction scale, or 16 or more on the quality-of-life scale.

  3. The frequency of anginal attack every week

    Time frame: Day-7 (if exist), Day 0, Day 7, Day 14, Day 30, Day 60, Day 90

    The frequency of anginal attack was recorded by the patients with the use of the diary cards which will be collected from the run-in period (Day -7) to the end of follow-up (Day 90).

  4. Canadian Cardiovascular Society (CCS) grading of angina pectoris

    Time frame: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90

  5. Consumption of Short-acting Nitrates

    Time frame: Day -7( if exist), Day 0, Day 7, Day 14, Day 30, Day 60, Day 90

  6. Change in the electrocardiogram (EKG)

    Time frame: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90

  7. Changes in the Serum Lipid, the high-sensitivity C-Reactive Protein(hs-CRP) and the Platelet Aggregation Rate

    Time frame: Day 0, Day 14

  8. Incidence of new-onset major vascular events in 90 days

    Time frame: Day 90

    Major adverse vascular events include ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction and vascular-related death.

  9. Overall mortality in 90 days

    Time frame: Day 90

  10. Incidence of severe hemorrhages in 90 days

    Time frame: Day 90

    The definition of "Severe hemorrhages" is in accordance with the GUSTO bleeding criteria, including fatal intracranial hemorrhage (ICH), symptomatic intracerebral hemorrhage (sICH) or which could result in substantial hemodynamic compromise requiring treatment.

  11. Incidence of moderate hemorrhages in 90 days

    Time frame: Day 90

    The definition of "moderate hemorrhages" is in accordance with the GUSTO bleeding criteria, which requires blood transfusion but not results in hemodynamic compromise.

  12. Documentation of adverse events (AEs) and serious AEs

    Time frame: 90 days

Other outcomes

  1. The profiles of micro-RNA in 60 patients selected from certain centers

    Time frame: Day 0, Day 14, Day 90

  2. The profiles of mRNA in 60 patients selected from certain centers

    Time frame: Day 0, Day 14, Day 90

Sponsors and collaborators

Lead sponsor

China Academy of Chinese Medical Sciences

Other

Collaborators

  • China Food and Drug Administration

Registry information

Official study title

A Randomized, Multi-center, Double-blind, Placebo-controlled Trial of Danhong Injection in the Treatment of Chronic Stable Angina

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Sep 7, 2012
Registry last updated
Oct 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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