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Danhong Injection in the Treatment of Unstable Angina Pectoris

This study is currently recruiting participants.
Verified October 2016 by Zhong Wang, China Academy of Chinese Medical Sciences
Sponsor:
ClinicalTrials.gov Identifier:
NCT02007187
First Posted: December 10, 2013
Last Update Posted: October 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
China Food and Drug Administration
Information provided by (Responsible Party):
Zhong Wang, China Academy of Chinese Medical Sciences
  Purpose
The purpose of this study is to determine the efficacy and safety of Danhong injection in the treatment of unstable angina pectoris.

Condition Intervention Phase
Unstable Angina Pectoris Drug: Danhong injection Other: Standard medical care Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Multicenter, Parallel Controlled Clinical Trial of Danhong Injection in the Treatment of Unstable Angina Pectoris

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change from baseline of the Quantification score of angina pectoris at Day 7 [ Time Frame: 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.


Secondary Outcome Measures:
  • Total score of symptoms questionnaire of TCM [ Time Frame: Day 0, Day 7 ]
    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.

  • Use of Short-acting Nitrates [ Time Frame: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 28 ]
  • Change in the electrocardiogram (ECG) [ Time Frame: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 28 ]
    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.

  • The proportion of patients who are undergoing PCI [ Time Frame: Day 7, Day 28 ]
  • Change in Seattle Angina Questionnaire [ Time Frame: Day 0, Day 28 ]
    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.

  • Incidence of adverse events (including serious adverse events) in 28 days [ Time Frame: 28 days ]

Estimated Enrollment: 160
Study Start Date: December 2013
Estimated Primary Completion Date: June 2017 (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 2-3 hours every day for 7 days.
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
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 2-3 hours every day for 7 days.
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.

  Eligibility

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02007187


Contacts
Contact: Zhong Wang, M.D., Ph.D. 8610-64014411 ext 3308 zhonw@vip.sina.com

Locations
China, Beijing
Xuanwu Hospital Completed
Beijing, Beijing, China, 100053
Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine Recruiting
Beijing, Beijing, China, 100700
Contact: Xian Wang, M.D.       wx0515@hotmail.com   
Principal Investigator: Xian Wang, M.D.         
China, Guangdong
The First Affiliated Hospital of Guangzhou University of Chinese Medicine Completed
Guangzhou, Guangdong, China, 510405
China, Heilongjiang
The First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine Completed
Ha'erbin, Heilongjiang, China, 150040
China, Henan
Zhengzhou No.7 People's Hospital Recruiting
Zhengzhou, Henan, China, 450006
Contact: Yu-jie Zhao         
Principal Investigator: Yu-jie Zhao         
China, Hunan
The First Hospital of Changsha Completed
Changsha, Hunan, China, 410005
China, Jilin
The Affiliated Hospital to Changchun University of Chinese Medicine Completed
Changchun, Jilin, China, 130021
China, Liaoning
Hospital 463 of P.L.A. Completed
Shenyang, Liaoning, China, 110046
China, Tianjin
First Teaching Hospital of Tianjin University of T.C.M. Completed
Tianjin, Tianjin, China, 300193
Sponsors and Collaborators
China Academy of Chinese Medical Sciences
China Food and Drug Administration
Investigators
Principal Investigator: Zhong Wang, M.D., Ph.D. Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences
Principal Investigator: Xian Wang, M.D. Dongzhimen Hospital, Beijing
Study Director: Xiao-xi Du, Professor China Food and Drug Administration
  More Information

Responsible Party: Zhong Wang, Professor, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT02007187     History of Changes
Other Study ID Numbers: 2011ZX09304-07V1.2
First Submitted: December 5, 2013
First Posted: December 10, 2013
Last Update Posted: October 11, 2016
Last Verified: October 2016

Keywords provided by Zhong Wang, China Academy of Chinese Medical Sciences:
Unstable Angina Pectoris
Randomized Controlled Trial
Traditional Chinese Medicine

Additional relevant MeSH terms:
Angina Pectoris
Angina, Unstable
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms