Efficacy and Safety Study of Guanxin Shutong Capsule to Treat Chronic Stable Angina

• Status: Unknown status
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shaanxi Buchang Pharmaceutical Co., Ltd
• Treatments: Nitroglycerin

Criteria

Inclusion Criteria:

• 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:

1. had coronary angiography and verified a least one main branch of coronary stenosis ≥50%;

2. have typical angina symptom, and also have positive ETT result or CTA shows at least one main branch of coronary stenosis ≥50%;

3. had history of myocardial infarct (at least 6 months).

• Written informed consent.

Exclusion Criteria:

• 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.