Efficacy and Safety Study of Guanxin Shutong Capsule to Treat Chronic Stable Angina: A Randomised, Double-blind, Placebo-controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Exercise treadmill testing (ETT)
研究概览
简要总结
Compared with placebo, assess of the efficacy and safety of Guanxin Shutong capsule to treat chronic stable angina (syndrome of blood stasis resistance), and the result will be used for the basis of later Ⅳ clinical trial.
详细描述
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Procedures 1.1 Start-up stage (-14~0 Day)
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Inquire medical history, medication use, accompanied treatment, etc;
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Sign informed consent;
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Measure vital signs and conduct physical examination;
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Record symptom and signs;
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Confirm inclusion/exclusion criteria, and put patients who meet inclusion criteria into start-up stage;
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Record participators' history of angina pectoris and treatment, or select stable angina from outpatient service (without medicate);
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Allocate screen number, hand out Guanxi Shutong Capsules Placebo and record card of angina/nitroglycerin used;
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Advise patient return visit with an empty belly 2 weeks later. 1.2 Interview 1 (Baseline 0 Day)
(1) Measure vital signs; (2)Accomplish all the examination items: Blood routines, Urine routines, Stool routines + Occult blood, Hepatorenal function (AST, ALT, TBIL, ALP, γ-GT, BUN, Cr), Four coagulation tests (TT, PT, APTT, FIB), Blood fat (TC, TG, HDL-C, LDL-C), 12 leads electrocardiogram, Seattle Angina Ques-tionnaire (SAQ). Additionally, premenopausal women receive urine pregnancy test; (3) Exercise treadmill testing (ETT): around am. 10:00 (Note: Just for the patients who need ETT); (4) Record symptoms and signs ( Score of syndrome of Chinese medicine and Score of angina); (5) Randomize and allocate drug number; (6) Hand out the drugs for 2 weeks and record card of angina/nitroglycerin used; (7) Advise patient return visit 2 weeks later. 1.3 Interview 2 (14±2 Day)
- Inquire adverse events;
- Inquire accompanied treatment and record combined medication.
- Measure vital signs;
- Record symptoms and signs (Score of syndrome of Chinese medicine and Score of angina);
- Withdraw remained drugs and box, and record card;
- Hand out the drugs for 2 weeks and record card of angina/nitroglycerin used;
- Advise patient return visit 2 weeks later. 1.4 Interview 3 (28±2 Day)
(1) Inquire adverse events; (2) Inquire accompanied treatment and record combined medication. (3) Measure vital signs; (4) Record symptoms and signs (Score of syndrome of Chinese medicine and Score of angina); (5) 12 leads electrocardiogram (6) Accomplish all the examination items: Blood routines, Urine routines, Stool routines + Occult blood, Hepatorenal function (AST, ALT, TBIL, ALP, γ-GT, BUN, Cr), Four coagulation tests (TT, PT, APTT, FIB), Blood fat (TC, TG, HDL-C, LDL-C), 12 leads electrocardiogram, Seattle Angina Ques-tionnaire (SAQ); (7) Exercise treadmill testing (ETT) (Note: Just for the patients who need ETT); (8) Withdraw remained drugs and box, and record card; (9) Assess compliance; (10) Summarize the clinical trial.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptom of chronic stable angina is sustained for 3 months or over 3 months (typical symptoms of myocardial ischemia occurred at least 2 times in the latest week, and angina type is stable angina (Canada CCS class Ⅰ、Ⅱ or Ⅲ);
- •Blood stasis resistance on traditional Chinese medicine syndrome differentiation;
- •Patients who meet the following any situation:
- •had coronary angiography and verified a least one main branch of coronary stenosis ≥50%;
- •have typical angina symptom, and also have positive ETT result or CTA shows at least one main branch of coronary stenosis ≥50%;
- •had history of myocardial infarct (at least 6 months).
- •Written informed consent.
排除标准
- •Acute coronary syndrome or highly suspected acute coronary syndrome;
- •Variant angina or unstable angina;
- •Myocardial infarction within the past 6 months;
- •Left main disease and without revascularization was verified through angiography or CTA;
- •Moderate to severe aortic stenosis, hypertrophic Obstructive Cardiomyopathy or congestive heart-failure (NYHA class Ⅲ-Ⅳ);
- •Patients who were received PCI/CABG within 1 year;
- •Patients who are poor control of high blood pressure (SBP>170mmHg, or DBP>100mmHg);
- •Patients who have hypotension (SBP<90mmHg, DBP<60mmHg) or had orthostatic hypotension;
- •ECG shows complete left bundle branch block, pre-excitation syndrome, left ventricular hypertrophy or pacemaker rhythm;
- •Hypohepatia (ALT or bilirubin level is higher than upper limit), renal insufficiency (serum creatinine level is higher than upper limit);
- •Active peptic ulcer or skin ulcer;
- •Diagnosed chest pain caused by severe neurosis, menopausal syndrome, hyperthyroidism, cervical spondylosis, gallbladder-cardiac syndrome, gastroesophageal reflux, esophageal hiatus hernia or in aortic dissection;
- •Patients had hematological disorder, specific bleeding or warfarin caused bleeding;
- •Drug abuser, patients with history of alcoholism in the past 2 years or dependency to known drugs;
- •Psychopath;
- •Patients who can't compelet exercise test (note: just for partial patients who need to complete exercise test);
- •Pregnancy or lactation;
- •Patients who are known or suspected hypersensitive to the study medicine or allergic constitution;
- •Patients who were received big surgery within 4 weeks or participated in other clinical trials within 3 months.
研究组 & 干预措施
Guanxin Shutong Capsule
3 capsules once, tid, Oral Duration: 4 weeks
干预措施: Guanxin Shutong Capsule (Drug)
Guanxin Shutong Capsule
3 capsules once, tid, Oral Duration: 4 weeks
干预措施: nitroglycerine (Drug)
Placebo Capsule
Placebo capsule and Guanxin Shutong Capsule the same appearance are made by SHAANXI BUCHANG PHARMACEUTICAL CO.,LTD.
3 capsules once, tid, Oral Duration: 4 weeks
干预措施: Placebo Capsule (Drug)
Placebo Capsule
Placebo capsule and Guanxin Shutong Capsule the same appearance are made by SHAANXI BUCHANG PHARMACEUTICAL CO.,LTD.
3 capsules once, tid, Oral Duration: 4 weeks
干预措施: nitroglycerine (Drug)
结局指标
主要结局
Exercise treadmill testing (ETT)
时间窗: 4 weeks
ST-segment displacement in electrocardiogram: Observe ST-segment displacement of J point after 60ms, including the degree of ST-segment depression.
Therapeutic effect to Angina ( Average value of angina frequency)
时间窗: 6 weeks
Record angina frequency per week. Record date is Start-up Stage 1st week, Start-up Stage 2st week, Interview Stage 1st week, Interview Stage 2st week, Interview Stage 3st week and Interview Stage 4st week (Toal of 6 times).
次要结局
- Seattle Angina Ques-tionnaire (SAQ)(4 weeks)
- Electrocardiogram manifestation(4 weeks)
- Scores on Chinese medical syndrome scale(4 weeks)
- Time of angina break out from exercise beginning in ETT(4 weeks)
- Time of ST below 1 mm from exercise beginning in ETT(4 weeks)
- Usage of nitroglycerine per day (average value)(4 weeks)