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Randomized controlled clinical study on the effect of Shenfu Injection on clinical outcomes in patients with acute ST-segment elevation myocardial infarction undergoing primary PCI

Randomized controlled clinical study on the effect of Shenfu Injection on clinical outcomes in patients with acute ST-segment elevation myocardial infarction undergoing primary PCI

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600129490
Enrollment
Unknown
Registered
2026-08-05
Start date
2026-08-20
Completion date
Unknown
Last updated
2026-08-10

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

Conditions

acute ST-segment elevation myocardial infarction (STEMI)

Interventions

control group:Standard of care for STEMI
Experimental group:Standard of care for STEMI plus Shenfu injection

Sponsors

Shanghai Ninth Peoples Hospital,Shanghai JiaoTong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.patients with STEMI aged = 18 years and = 85 years; 2.eligible for emergency PCI and have undergone emergency coronary intervention; 3.able to understand the purpose of this study, voluntarily participate, and sign the informed consent form;

Exclusion criteria

Exclusion criteria: 1. Left main coronary artery disease, graft vessel disease, or acute stent thrombosis; 2. Cardiogenic shock or hemodynamic instability (requiring mechanical circulatory support); 3. Prior history of myocardial infarction or coronary artery bypass grafting; 4. Systolic blood pressure > 160 mmHg; 5. Presence of other severe comorbidities (e.g., malignancy, organ transplantation or candidates for transplantation); 6. Known allergy to Shenfu Injection; 7. Severe hepatic or renal dysfunction (ALT/AST > 3 x upper limit of normal, eGFR < 30 mL/min/1.73 m^2).

Design outcomes

Primary

MeasureTime frame
Composite endpoint of MACEs;

Secondary

MeasureTime frame
Adverse events, serious adverse events;cardiac funciton;Myocardial infarct size;

Countries

China

Contacts

Public ContactJun Gu

Shanghai Ninth Peoples Hospital,Shanghai JiaoTong University School of Medicine

forrestgu@126.com+86 21 2327 1699

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 25, 2026