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Danhong Injection in the Treatment of Unstable Angina Pectoris

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by China Academy of Chinese Medical Sciences
Sponsor:
Collaborator:
China Food and Drug Administration
Information provided by (Responsible Party):
Zhong Wang, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT02007187
First received: December 5, 2013
Last updated: October 27, 2014
Last verified: October 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 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 ] [ Designated as safety issue: No ]
    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 ] [ 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.

  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • Change in Seattle Angina Questionnaire [ Time Frame: Day 0, Day 28 ] [ 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.

  • Incidence of adverse events (including serious adverse events) in 28 days [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 160
Study Start Date: December 2013
Estimated Primary Completion Date: December 2015 (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

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02007187

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

Locations
China, Beijing
Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine Active, not recruiting
Beijing, Beijing, China, 100700
China, Guangdong
The First Affiliated Hospital of Guangzhou University of Chinese Medicine Recruiting
Guangzhou, Guangdong, China, 510405
Contact: Wei Wu, M.D.       zywuwei@163.com   
Principal Investigator: Wei Wu, M.D.         
China, Heilongjiang
The First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine Not yet recruiting
Ha'erbin, Heilongjiang, China, 150040
Contact: Ya-bin Zhou, M.D.       zhouyabin@hotmail.com   
Principal Investigator: Ya-bin Zhou, M.D.         
China, Hunan
The First Hospital of Changsha Recruiting
Changsha, Hunan, China, 410005
Contact: Guang Fu, Professor       fuguangyisheng@163.com   
Principal Investigator: Guang Fu, Professor         
China, Jilin
The Affiliated Hospital to Changchun University of Chinese Medicine Not yet recruiting
Changchun, Jilin, China, 130021
Contact: Yue Deng, M.D.       dyue7138@sina.com   
Principal Investigator: Yue Deng, M.D.         
China, Liaoning
Hospital 463 of P.L.A. Not yet recruiting
Shenyang, Liaoning, China, 110046
Contact: Bai-song Yang         
Principal Investigator: Bai-song Yang         
China, Tianjin
First Teaching Hospital of Tianjin University of T.C.M. Recruiting
Tianjin, Tianjin, China, 300193
Contact: Xi-Yan Yang, Professor       YangXiYan888@aliyun.com   
Principal Investigator: Xi-Yan Yang, Professor         
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

No publications provided

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
Study First Received: December 5, 2013
Last Updated: October 27, 2014
Health Authority: China: Ministry of Science and Technology
China: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 25, 2014