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A prospective, multicenter, observational study to assess the efficacy and safety of Sacubitril Valsartan compared with valsartan in patients with acute myocardial infarction

A prospective, multicenter, observational study to assess the efficacy and safety of Sacubitril Valsartan compared with valsartan in patients with acute myocardial infarction

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000039437
Enrollment
Unknown
Registered
2020-10-28
Start date
2020-10-27
Completion date
Unknown
Last updated
2021-02-01

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

Conditions

acute myocardial infarction

Interventions

Sacubatril valsartan group:Sacubatril valsartan, valsartan

Sponsors

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

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Patients with acute myocardial infarction (AMI) who underwent percutaneous coronary intervention (PCI) within 24 hours of onset, have signed an informed consent form, and have been evaluated and received drug treatment within 24 hours. Subjects registered to participate in this study 1. Written informed consent must be obtained before any assessment; 2. Male or female patients over 18 years old; 3. According to the accepted definition of myocardial infarction*, the diagnosis is AMI; AMI is defined as: acute myocardial injury and clinical evidence of myocardial ischemia. The evidence of myocardial ischemia includes: Symptoms of myocardial ischemia; New-onset ischemic ECG changes; Pathological Q waves appear; Imaging evidence and ischemic etiology of new-onset viable myocardial loss or local wall motion abnormalities; Confirm coronary thrombosis by angiography or autopsy. 4. AMI patients who underwent PCI within 24 hours of onset and were evaluated and received sacubitril valsartan or valsartan within 24 hours of onset. The patients were followed up at 0, 1, 3, 6, and 12 months after onset.

Exclusion criteria

Exclusion criteria: 1. Cardiogenic shock occurred within 24 hours; 2. The patient has a known history of angioedema; 3. Known or suspected bilateral renal artery stenosis; 4. The simplified dietary modification test for kidney disease (MDRD) formula is used to calculate eGFR 5.2 mmol/L; 6. A history of allergy to sacubitril, valsartan, ACEI, ARB drugs, or NEP inhibitors or other drugs of similar chemical class; 7. Any organ system (except for localized basal cell carcinoma of the skin) malignant tumor history in the past 3 years, and life expectancy is less than 1 year; 8. The patient is considered unsuitable to participate in the study, including mental, behavioral, or cognitive impairment that affects the patients ability to understand, obey the protocol, or complete follow-up operations.

Design outcomes

Primary

MeasureTime frame
LVEF;LVIDd;IVSd;LA;Heart/chest ratio;NT pro-BNP;

Countries

China

Contacts

Public ContactFu Guosheng

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

alann17@163.com+86 13605800707

Outcome results

None listed

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