A Randomized, Double-blind, Placebo-controlled Trial of Dan-shen Extract in Patients With Stable Angina Pectoris
试验速览
- 阶段
- 4 期
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Serum level of Lp-PLA2
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, adaptive clinical trial, which will assess the effect of DanshenDuofensuanyan[Danshen (a kind of Chinese herbal drug) extract] treatment on Lipoprotein associated phospholipase A2 level in patients with stable angina pectoris.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age:18 years-75 years;
- •Written informed consent;
- •Patients with a clinical diagnosis of chronic stable angina, which fulfil one of the following conditions:
- •Symptoms that support the diagnosis of chronic angina and/or a history of an abnormal exercise response limited by angina and/or electrocardiograph (ECG) changes
- •a history of myocardial infarction and ST-T changes,
- •stenosis of more than 50 % in at least one major epicardial coronary artery, as shown by coronary angiography or computed tomography angiography,
- •Coronary heart disease confirmed by radionuclide angiocardiography;
- •Patients with moderate angina pectoris, which is defined as Grade II or III on the Canadian Cardiovascular Society Angina Grading Scale.
排除标准
- •Patients with severe complications that would complicate the condition, as assessed by the investigator, including liver or renal dysfunction, severe cardiopulmonary dysfunction, pulmonary hypertension, chronic obstructive pulmonary disease, a history of epilepsy or cerebral haemorrhage.
- •Patients who were angina-free during the run-in period without taking any drug.
- •Patients who experienced myocardial infarction or who were classified as Grade IV on the Canadian Cardiovascular Society Angina Grading Scale within the preceding 3 months.
- •Patients with chest pain that is caused by any other disease (e.g., acute myocardial infarction, severe neurosis, menopausal syndrome or hyperthyroidism).
- •Patients with a history of drug-induced bleeding or a history of bleeding caused by warfarin.
- •Patients with a history of haematopoietic disorder.
- •Patients who have had surgery within the previous 4 weeks or who have a haemorrhagic tendency.
- •Women who are pregnant or lactating or who have a positive pregnancy test, or women who have a menstrual period at baseline.
- •Patients who are participating in other trials or who have participated in other trials within the past 3 months.
- •Patients with a history of allergy or with a known or suspected allergy to the study drug.
- •Patients with a known or suspected history of alcohol or drug abuse within the past 2 years.
- •Patients with a mental disorder.
- •Family members or relatives of the study centre staff.
- •Inability to adhere to study procedures
研究组 & 干预措施
Dan-shen extract
Based on the standard medical care, 200mg of Danshenduofensuanyan, added into 250ml of 0.9% saline injection, given by continuous IV infusion at 2.5ml/min within 2 hours, once a day during the patients' hospitalization. Danshen drop spill (30 pill/day) taken orally for 60 days after discharge.
干预措施: Dan-shen extract (Drug)
Dan-shen extract
Based on the standard medical care, 200mg of Danshenduofensuanyan, added into 250ml of 0.9% saline injection, given by continuous IV infusion at 2.5ml/min within 2 hours, once a day during the patients' hospitalization. Danshen drop spill (30 pill/day) taken orally for 60 days after discharge.
干预措施: Standard medical care (Other)
Placebo
Based on the standard medical care, placebo was 200mg of glucose, added into 250ml of 0.9% saline injection, given by continuous IV infusion at 2.5ml/min within 2 hours.
干预措施: Placebo (Drug)
Placebo
Based on the standard medical care, placebo was 200mg of glucose, added into 250ml of 0.9% saline injection, given by continuous IV infusion at 2.5ml/min within 2 hours.
干预措施: Standard medical care (Other)
结局指标
主要结局
Serum level of Lp-PLA2
时间窗: up to Day 60 after discharge
次要结局
- carotid arterial intima-media wall thickness(Day0 and Day 60 after discharge)
- Canadian Cardiovascular Society (CCS) grading of angina pectoris(Day 0 and Day 60 after discharge)
- Incidence of new-onset major vascular events(up to 60 days after discharge)
- Changes in the Serum Lipid, the high-sensitivity C-Reactive Protein(hs-CRP) and the Platelet Aggregation Rate(Day 0 and Day 60 after discharge)
- 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(Day 0 and Day 60 after discharge)
- Change in the electrocardiogram (EKG)(Day 0 and Day 60 after discharge)
- Incidence of severe hemorrhages(up to 60 days after discharge)
- Incidence of moderate hemorrhages(up to 60 days after discharge)
研究者
ChunLing Wang
Attending Doctor
Taizhou Fourth People's Hospital