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A Clinical Study on the Interventional Clinical Efficacy of Shexiang Baoxin Pills in Patients with STEMI (Qi-Stagnation and Blood-Stasis Syndrome) After PCI.

Effect of Shexiang Baoxin Pill on Myocardial Fibrosis in Patients with Qi-Stagnation and Blood-Stasis Syndrome after PCI for Acute ST-Segment Elevation Myocardial Infarction: A Clinical Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101820
Enrollment
Unknown
Registered
2025-04-30
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-05-05

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

Conditions

Acute ST-Elevation Myocardial Infarction

Interventions

Control group:Preoperative medication:Aspirin: 300 mg for all patients
P2Y12 inhibitors: Patients <75 years: Clopidogrel 600 mg?or?Ticagrelor 180 mg or Patients =75 years: Clopidogrel 300 mg. Intraoperative medication:Heparin: Intravenous injection (100 IU/kg)
High thrombus burden (thrombus score =3):Tirofiban: Initial bolus of 10 µg/kg, followed by continuous intravenous infusion at 0.15 µg/kg/min for 24 hours.Adjusted heparin dose: 50–70 IU/kg. Long-term
Statins.
Treatment Group:Standard Western medical treatment + Shexiang Baoxin Pills
Shexiang Baoxin Pills administration:Pre-PCI: 90 mg sublingually before percutaneous coronary intervention (PCI).Post-PCI: 45 mg orally three times daily, taken with warm water, for 28 days.

Sponsors

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Gender and Age: Male or female patients aged >18 years. 2. Diagnosis and Treatment: First-time diagnosis of acute myocardial infarction with persistent chest pain >30 minutes, symptom onset to hospital admission <=12 hours, confirmed by coronary angiography after admission as single-vessel, double-vessel, or triple-vessel disease, and successful completion of PCI. 3. Traditional Chinese Medicine (TCM) Syndrome: Meet the diagnostic criteria for Qi Stagnation and Blood Stasis Syndrome according to TCM guidelines. 4. Comorbidities: Patients with comorbidities (e.g., hypertension, diabetes) are eligible if their conditions are well-controlled by current medications.

Exclusion criteria

Exclusion criteria: 1. Hypersensitivity to Shexiang Baoxin Pills; 2. Comorbidities including rheumatic heart disease, congenital heart disease, valvular heart disease, or idiopathic cardiomyopathy; 3. Post-implantation of cardiac pacemaker or history of previous myocardial infarction; 4. Severe or uncontrolled medical conditions, such as: Severe heart failure (NYHA class III-IV); Severe hepatic or renal insufficiency; Hematological diseases, systemic immune disorders, or active malignant tumors; 5. Acute or recovery-phase conditions: Postoperative recovery period or recovery from major trauma; Active infectious diseases; 6. Pregnancy or lactation: Positive urine pregnancy test; Female patients who are pregnant or lactating; 7. Psychiatric or active infectious diseases.

Design outcomes

Primary

MeasureTime frame
GLS;

Secondary

MeasureTime frame
RS;CS;APN;Gal-3;TGF-ß;NT-proBNP;PSD;MWSI;LVEF;LVEDV;LVESV;FS;LTBP4;sST2;TCM Syndrome Score;CRP;IL-6;

Countries

China

Contacts

Public ContactWang Xiaolong

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

wxlqy0214@163.com+86 135 0199 1450

Outcome results

None listed

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