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Preconditioning of PCSK9 inhibitors in the treatment of high-risk NSTE-ACS

Preconditioning of PCSK9 inhibitors in the treatment of high-risk NSTE-ACS

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083087
Enrollment
Unknown
Registered
2024-04-15
Start date
2024-05-07
Completion date
Unknown
Last updated
2024-04-22

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

Conditions

ACS

Interventions

Control group :0.9%Nacl
Treatment group:evolocumab 420mg

Sponsors

Shanxi Bethune Hospita
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients must meet all of the following enrollment criteria to be enrolled in this study: 1. age at =18 years and gender; 2. a definitive diagnosis of non-ST-segment elevation acute coronary syndrome (unstable angina or non-ST-segment elevation acute myocardial infarction) by two physicians at the attending level or above; and treated with an early (within 48 hours) coronary angiography intervention management strategy; 3. Voluntarily participate and sign an informed consent form and be available for follow-up for more than 1 month.

Exclusion criteria

Exclusion criteria: Patients will not be enrolled in this study if they meet any of the following criteria: 1. acute ST-segment elevation myocardial infarction; 2. acute non-ST-segment elevation coronary syndromes with very high risk features requiring emergency coronary angiography within 2h; 3. a clear history of statin intolerance or allergy; 4. a history of severe liver or muscle disease 5. renal failure with creatinine = 3 mg/dl; 6. patients with acute pulmonary edema or acute hemodynamic disorders; 7. right heart failure due to pulmonary disease; 8. patients preparing for heart transplantation or CRT, or who have received CRT; 9. female patients who are pregnant or planning to become pregnant 10. participation in a clinical trial of any drug within the previous 3 months 11. those who have a history of or are currently suffering from a tumor, or those who have pathologically confirmed precancerous lesions (e.g., ductal carcinoma in situ of the breast, or atypical hyperplasia of the uterine cervix); 12. patients who are found to have malignant masses in the body by examination (physical examination, or X-ray or ultrasound or other means), or patients who are found to have hyperplastic glands or adenomas that are endocrinologically active and affect cardiac or endocrine function, such as pheochromocytoma 13. the patient refuses to comply with the requirements of this study to complete the study; 14. in the judgment of the investigator, the patient is unable to complete the study or comply with the requirements of the study (for administrative reasons or otherwise).

Design outcomes

Primary

MeasureTime frame
Major adverse cardiac events at 30 days;

Secondary

MeasureTime frame
LDL-C lowering effects ; inflammatory biomarkers; platelet reactivity;treatment safety;assessment of myocardial injury after coronary intervention;assessment of acute kidney injury after coronary intervention;

Countries

China

Contacts

Public ContactQiang Zhou

Shanxi Bethune Hospital

zhangyanhui82@sina.com+86 153 8708 8572

Outcome results

None listed

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