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A randomized, multicenter trial evaluating the efficacy for early use of PCSK9 inhibitors before primary percutaneous coronary intervention in patients with Acute Myocardial Infarction

A randomized, multicenter trial evaluating the efficacy for early use of PCSK9 inhibitors before primary percutaneous coronary intervention in patients with Acute Myocardial Infarction

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035056
Enrollment
Unknown
Registered
2020-07-29
Start date
2020-08-01
Completion date
Unknown
Last updated
2020-08-03

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 group:The standard dose of evolocumab (140mg or 420 mg) or alirocumab (75mg or 150mg) is given before PPCI
control group:The same dose of normal saline is given before PPCI

Sponsors

Southeast University Zhongda Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Patients with an age between 18 and 70 years old; (2) Acute myocardial infarction patients with primary percutaneous coronary intervention (PPCI) indication and consent to PPCI; (3) Patients with an ability to understand research requirements and provide informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with a poor performance status, including coma, shock and tracheal intubation, etc; (2) Patients with severe renal insufficiency defined as estimated glomerular filtration rate (eGFR) was less than 30mL/min/1.73m2; (3) Patients with active liver disease or liver dysfunction defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) were above 3 times the upper limit of normal; (4) People with known hypersensitivity to contrast medium, heparin, aspirin, clopidogrel and ticagrelor; (5) Patients who have recently received PCSK9 inhibitors treatment; (6) Patients with with advanced cancer and have short life expectancies; (7) Pregnant or lactating women; (8) Patients with severe coronary calcification; (9) Patients unable to cooperate treatment or the researcher considers them inappropriate.

Design outcomes

Primary

MeasureTime frame
major cardiovascular adverse events;

Secondary

MeasureTime frame
the change in lipid parameters;

Countries

China

Contacts

Public ContactLi Yongjun

Southeast University Zhongda Hospital

liyongjunnj@hotmail.com+86 18602515266

Outcome results

None listed

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