DaZhu Rhodiola Rosea Capsule for Coronary Artery Disease With Angina Pectoris

• Status: Unknown status
• Trial end date: 2019-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to evaluate the efficacy and safety of traditional Chinese medicine DaZhu Rhodiola Rosea Capsule for treatment of coronary artery disease by observing angina symptoms, exercise capacity, and quality of life.

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

Details

• Lead Sponsor: Beijing Anzhen Hospital
• Collaborator: Jiangsu Kangyuan Pharmaceutical Co. Ltd

Criteria

Inclusion Criteria:

• Age 18 to 75 years old

• Coronary heart disease with grade Ⅱ or Ⅲ stable or unstable angina (≥ 2 times per week), or residual angina-like symptoms 1 month to 1 year post percutaneous coronary intervention (PCI) or 3 months to 1 year post coronary artery bypass surgery (CABG)

• Written informed consent

Exclusion Criteria:

• Acute myocardial infarction within 1 month before admission

• Patients who plan to undergo revascularization in the next 3 months

• Congestive heart failure, acute myocarditis or pericarditis, thrombophlebitis, pulmonary embolism, or severe neurosis within 3 months prior to admission

• Patients with uncontrolled high blood pressure (systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg), severe cardiopulmonary insufficiency (cardiac function grade Ⅲ, Ⅳ or left ventricular ejection fraction (LVEF) < 40%), severe arrhythmia (rapid atrial fibrillation and flutter, paroxysmal ventricular tachycardia, degree Ⅱ type Ⅱ and degree Ⅲ atrioventricular block, etc.)

• Severe liver, kidney and hematopoietic system dysfunction or psychosis (serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times the normal upper limit, or serum creatinine > 1.5 times the normal upper limit)

• History of bleeding or treatment with warfarin

• Implanted pacemakers

• Pregnant or lactating women

• Allergic to study drugs

• Legal disability (blindness, deafness, dumbness, intellectual disability, mental disability, physical disability)

• Patients who participated in other clinical trials within 3 months