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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005530
Enrollment
Unknown
Registered
2022-01-11
Start date
2022-01-11
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

angina

Interventions

Sponsors

Run Run Shaw Hospital, Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Peak VO2;

Secondary

MeasureTime frame
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;

Countries

China

Contacts

Public ContactFu Guosheng
Fugslh@126.com0571-86006246

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026