Danhong Injection in the Treatment of Chronic Stable Angina

This study is currently recruiting participants.
Verified April 2014 by China Academy of Chinese Medical Sciences
Sponsor:
Collaborator:
China: State Food and Drug Administration
Information provided by (Responsible Party):
Zhong Wang, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT01681316
First received: September 5, 2012
Last updated: April 21, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Chronic Stable Angina
Drug: Danhong injection
Other: Standard medical care
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Multi-center, Double-blind, Placebo-controlled Trial of Danhong Injection in the Treatment of Chronic Stable Angina

Resource links provided by NLM:


Further study details as provided by China Academy of Chinese Medical Sciences:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Total score of symptoms questionnaire of TCM [ Time Frame: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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).

  • Canadian Cardiovascular Society (CCS) grading of angina pectoris [ Time Frame: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90 ] [ Designated as safety issue: No ]
  • Consumption of Short-acting Nitrates [ Time Frame: Day -7( if exist), Day 0, Day 7, Day 14, Day 30, Day 60, Day 90 ] [ Designated as safety issue: No ]
  • Change in the electrocardiogram (EKG) [ Time Frame: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90 ] [ Designated as safety issue: No ]
  • Changes in the Serum Lipid, the high-sensitivity C-Reactive Protein(hs-CRP) and the Platelet Aggregation Rate [ Time Frame: Day 0, Day 14 ] [ Designated as safety issue: No ]
  • Incidence of new-onset major vascular events in 90 days [ Time Frame: Day 90 ] [ Designated as safety issue: Yes ]
    Major adverse vascular events include ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction and vascular-related death.

  • Overall mortality in 90 days [ Time Frame: Day 90 ] [ Designated as safety issue: Yes ]
  • Incidence of severe hemorrhages in 90 days [ Time Frame: Day 90 ] [ Designated as safety issue: Yes ]
    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.

  • Incidence of moderate hemorrhages in 90 days [ Time Frame: Day 90 ] [ Designated as safety issue: Yes ]
    The definition of "moderate hemorrhages" is in accordance with the GUSTO bleeding criteria, which requires blood transfusion but not results in hemodynamic compromise.

  • Documentation of adverse events (AEs) and serious AEs [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Changes in exercise tolerance tests (ETT)in 290 patients at day 14 [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    Changes in Exercise Tolerance Tests (ETT) at day 14 was defined as change in time to 0.1mv ST-segment depression and change in the Total Exercise Duration (TED) during Exercise Tolerance Testing (ETT) from baseline to day 14.

  • The profiles of micro-RNA in 60 patients selected from certain centers [ Time Frame: Day 0, Day 14, Day 90 ] [ Designated as safety issue: Yes ]
  • The profiles of mRNA in 60 patients selected from certain centers [ Time Frame: Day 0, Day 14, Day 90 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 870
Study Start Date: December 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Danhong injection
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.
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 Chronic Stable Angina (2007).
Placebo Comparator: Placebo
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.
Other: Standard medical care
Standard medical care is in accordance with China Guideline for the diagnosis and treatment of Chronic Stable Angina (2007).
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01681316

Contacts
Contact: Zhong Wang, Professor 8610-64014411 ext 3308 zhonw@vip.sina.com
Contact: Jun Liu, Ph.D. 8610-64014411 ext 2805 franlj1104@yahoo.com.cn

  Show 30 Study Locations
Sponsors and Collaborators
China Academy of Chinese Medical Sciences
China: State Food and Drug Administration
Investigators
Principal Investigator: Zhong Wang, Professor Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences
Principal Investigator: Yun-dai Chen, Professor Chinese PLA General Hospital(301 Hospital)
Study Chair: Yong-yan Wang, Professor Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences
Study Director: Xiao-xi Du, Professor China: State Food and Drug Administration
  More Information

No publications provided

Responsible Party: Zhong Wang, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT01681316     History of Changes
Other Study ID Numbers: DH20120703
Study First Received: September 5, 2012
Last Updated: April 21, 2014
Health Authority: China: Ministry of Science and Technology

Keywords provided by China Academy of Chinese Medical Sciences:
Chronic Stable Angina
Randomized Controlled Trial
Traditional Chinese Medicine

Additional relevant MeSH terms:
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on April 23, 2014