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A multicenter, randomized, controlled trial comparing the efficacy and safety of sacubitril valsartan in the prevention of cardiac remodeling in patients with acute myocardial infarction after direct PCI

A multicenter, randomized, controlled trial comparing the efficacy and safety of sacubitril valsartan in the prevention of cardiac remodeling in patients with acute myocardial infarction after direct PCI

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051979
Enrollment
Unknown
Registered
2021-10-11
Start date
2022-01-01
Completion date
Unknown
Last updated
2022-06-27

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

Conditions

acute myocardial infarction

Interventions

Experimental group1:Start taking sacubitril valsartan within 2 hours after PCI
Experimental group2:Start taking sacubitril valsartan within 3-7 days after PCI

Sponsors

Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.At least 18 years old; 2.Diagnosis of AMI according to the accepted definition of myocardial infarction; 3.AMI patients who received PCI within 24 hours of onset can be treated with sacubitril valsartan according to the judgment of the clinician; 4.Voluntarily participate in this study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1.Cardiogenic shock has occurred within 24 hours; 2.The patient has a known history of angioedema; 3.Known or suspected bilateral renal artery stenosis; 4.When screening, adopt the simplified modified diet for kidney disease (MDRD) formula to calculate eGFR 5.2 mmol/L during screening; 6.Have a history of allergy to sacubitril valsartan or neprilysin inhibitors or other drugs of similar chemical categories; 7.History of malignant tumor of any organ system in the past 3 years, and the life expectancy is less than 1 year; 8.Vulnerable groups, including mentally ill people, critically ill patients, pregnant women, minors, people with cognitive impairment, etc.

Design outcomes

Primary

MeasureTime frame
Left ventricular end diastolic volume index;Left ventricular end systolic volume index;Left atrial volume index;Ratio of peak E to peak A;Left ventricular end diastolic volume;Left ventricular end systolic volume;Left ventricular ejection fraction;Cardiothoracic ratio;Amino terminal brain natriuretic peptide progen;

Countries

China

Contacts

Public ContactFu Guosheng

Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine

fugs@zju.edu.cn+86 13605800707

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 13, 2026