Clinical Trial of Suxiao Jiuxin Pill to Protect Endothelial Function in Patients With Acute Coronary Syndrome

Phase 4

• Conditions: Acute coronary syndrome

• Registration Number: ITMCTR2100005344
• Lead Sponsor: The second affiliated hospital of guangzhou university of traditional Chinese medicine Hospital guangzhou

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) Both acute coronary syndrome and qi stagnation and blood stasis syndrome met the diagnostic criteria;

(2) Aged between 30 and 75;

(3) Patients or their family members agreed to participate in the study and signed informed consent.

Introduction period: Before the trial, patients should stop taking other Chinese patent medicines, TCM decoction and TCM injection for treating cardiovascular and cerebrovascular diseases or promoting blood circulation and removing blood stasis.

Exclusion Criteria

(1) Permanent serious arrhythmia: III degree ATrioventricular block, pathological sinus syndrome;

(2) cardiac arrest, cardiopulmonary resuscitation (CPR);

(3) Severe heart failure: New York Heart function Grade III-IV;

(4) acute cerebrovascular diseases (ischemic stroke, hemorrhagic stroke);

(5) severe diseases of the blood system (hemophilia, severe anemia, thrombocytopenic purpura, primary thrombocytopenia);

(6) severe renal insufficiency (serum creatinine level =265umol/L);

(7) severe liver disease (cirrhosis or liver cancer), liver function damage (serum glutamic-pyruvic transaminase/glutamic-oxalacetic transaminase > 3 times the normal upper limit);

(8) patients who may affect drug absorption after gastrointestinal surgery;

(9) Malignant tumors or life expectancy =2 years;

(10) persons with mental disorders or low intelligence;

(11) patients requiring coronary artery bypass graft (heart bypass graft);

(12) allergic to the known ingredients of the test drug;

(13) severe respiratory diseases such as severe chronic obstructive pulmonary disease, severe pulmonary hypertension and pulmonary embolism;

(14) women who are breast-feeding or pregnant, or women of childbearing age who plan to have a pregnancy within 6 months after screening, or who have a positive urine pregnancy test; Or male patients with fertility or sperm donation plans;

(15) Suspected or confirmed history of alcohol or drug abuse;

(16) Screening of patients who had participated in clinical trials of other drugs within 3 months prior to the examination;

(17) other patients considered unsuitable for the study by the investigator;

(18) long-term oral anticoagulants.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
endothelium dependent dilation;

Secondary Outcome Measures

Name	Time	Method
endothelium independent dilation;Major adverse cardiovascular events;? Endothelial factors: serum endothelium-type oxygen synthase 3 (ENOS-3), nitric oxide (NO), endothelin-1 (ET-1); ? Microcirculation: vascular endothelial growth factor (VEGF), thromboxane B (TXB2); ? Four items of blood lipid;(7) TCM syndrome integral;Seattle Angina scale score;Left ventricular ejection fraction (LVEF), left ventricular end diastolic diameter (LVEDD), left ventricular end systolic diameter (LVESD);