Unstable Angina Pectoris
Conditions
Keywords
Unstable Angina Pectoris, Randomized Controlled Trial, Traditional Chinese Medicine
Brief summary
The purpose of this study is to determine the efficacy and safety of Danhong injection in the treatment of unstable angina pectoris.
Interventions
A kind of injection made from two kind of Chinese herbs: salvia miltiorrhiza and safflower
OTHERStandard 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
DRUGPlacebo
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.
Sponsors
China Food and Drug Administration
China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of the Quantification score of angina pectoris at Day 7 | 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
| Measure | Time frame | Description |
|---|---|---|
| Use of Short-acting Nitrates | Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 28 | — |
| Change in the electrocardiogram (ECG) | 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. |
| Total score of symptoms questionnaire of TCM | 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. |
| Change in Seattle Angina Questionnaire | 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 | 28 days | — |
| The proportion of patients who are undergoing PCI | Day 7, Day 28 | — |
Countries
China
Outcome results
None listed