Post-marketing clinical re-evaluation of Guanxinning Tablet, a big brand Chinese patent medicine, in the treatment of angina pectoris after PCI

Phase 4

• Conditions: angina

• Registration Number: ITMCTR2200005530
• Lead Sponsor: Run Run Shaw Hospital, Zhejiang University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) Angina pectoris still occurred 3 to 18 months after PCI and was treated and managed according to the Guidelines for Percutaneous Coronary Intervention in China (2016). ?
(2) Patients with stable exertive angina who had =2 angina attacks per week in the previous month and whose severity was classified as Canadian Angina severity Scale (CCS) ? - ? were enrolled. ?
(3) Patients with ST segment depression or T wave inversion on electrocardiogram, positive motion plate or ischemic changes assessed by SPECT, PET, MRI, CT and other imaging. ?
(4) Patients who stopped using drugs for activating blood circulation and removing blood stasis for more than 2 weeks. ?
(5) Between 18 and 80 years old, male and female. ?
(6) Voluntarily participate in the study and sign the informed consent.

Exclusion Criteria

(1) Those eligible for revascularization. ?
(2) Patients with cardiac function grade ? (NYHA scale, see Appendix 2) or CCS Grade ? (Canadian Angina severity Scale). ?
(3) Patients with uncontrolled grade 3 hypertension (systolic blood pressure =180mmHg and/or diastolic blood pressure =110mmHg), severe cardiopulmonary insufficiency, severe arrhythmia, serious primary diseases of liver, kidney and hematopoietic system, or serious diseases affecting their survival (such as tumor) and mental illness. ?
(4) Combined with other clinical conditions that may increase the risk of bleeding, such as a history of major organ bleeding in the last six months (such as cerebral hemorrhage, upper gastrointestinal bleeding, etc.), platelet count less than 50×10^9/L, abnormal coagulation function, and oral warfarin anticoagulation treatment, etc. ?
(5) abnormal indexes of liver and kidney function (ALT, AST, Scr, BUN 3 times higher than the upper limit of normal reference range). ?
(6) Patients with allergic constitution, or food allergy to multiple drugs, or patients known to be allergic to the study drug (including its ingredients). ?
(7) those who have a pregnancy plan. ?
(8) Breast-feeding women. ?
(9) Vulnerable groups: including neurological diseases, cognitive impairment, critically ill patients, minors, pregnant women, etc. ?
(10) Patients who participated in other clinical trials within the last 1 month. ?
(11) The investigator suggested that there were other patients who were not eligible for inclusion.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peak VO2;

Secondary Outcome Measures

Name	Time	Method
METs;MACE;Weber classification of cardiac function;GAD-7;PHQ-9;Start time of ST segment depression or elevation by 1mm;Maximal oxygen uptake without oxygen threshold;VO2/HR;Angina symptom score;Canadian classification of angina severity;Maximum exercise load;