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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100005344
Enrollment
Unknown
Registered
2021-11-28
Start date
2021-12-31
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

Acute coronary syndrome

Interventions

The control group:Secondary prevention of coronary heart disease + placebo (5 tablets, P.O. TID)
The treatment group:Secondary Prevention of Coronary heart Disease + Suxiaojiuxin Pills (5 tablets, P.O. TID)

Sponsors

The second affiliated hospital of guangzhou university of traditional Chinese medicine Hospital guangzhou
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
endothelium dependent dilation;

Secondary

MeasureTime frame
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);

Countries

China

Contacts

Public ContactChen Bojun
1004548400@qq.com13760653929

Outcome results

None listed

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