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Effects of PCSK9 inhibitor therapy on fractional flow reserve in coronary borderline lesions

Effects of PCSK9 inhibitor therapy on fractional flow reserve in coronary borderline lesions

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055718
Enrollment
Unknown
Registered
2022-01-16
Start date
2022-03-01
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

Coronary atherosclerosis

Interventions

Intensive lipid-lowering group:On the basis of conventional statin therapy, use Repatha subcutaneous injection to treat 1 vial of Q2W
control group:Atorvastatin 20mg/day or rosuvastatin 10mg/day

Sponsors

Tianjin Medical University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 years and over; 2. Coronary angiography confirmed the presence of borderline coronary lesions in ACS patients; 3. The LDL-C levels on baseline (One of the following conditions can be met): (1) Baseline LDL-C >= 70 mg/dL or non-HDL-C >= 100 mg/dL who have received >= 4 weeks of continuous statin maximum tolerated dose therapy before enrollment; (2) Baseline LDL-C >= 125 mg/dL or non-HDL-C >= 155 mg/dLage before enrollment or not receiving statin therapy continuously; 4)Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Clinical instability (hemodynamic or electrical instability); 2. Uncontrolled arrhythmia, defined as recurrent or symptomatic ventricular tachycardia, drug-uncontrolled atrial fibrillation with rapid ventricular response within three months prior to screening; 3. Severe renal insufficiency (defined as eGRF < 30ml/min/1.73m^2); 4. Active liver disease or liver dysfunction, either documented in the patient's medical record or defined as an increase in AST or ALT greater than 3 times the upper limit of normal; 5. TSH is lower than the lower limit of normal or TSH rises more than 3 times the upper limit of normal; 6. Documented statin or rosuvastatin (any dose) intolerance or other statin intolerance; 7. Known hypersensitivity to contrast media, heparin, aspirin, ticagrelor or clopidogrel; 8. Known allergy to excipients that require the use of the drug; 9. Patients who have been treated with ivolumab or other PCSK9 inhibitors; 10. Received cholesteryl ester transfer protein inhibitor treatment within 12 months before screening; 11. Received systemic steroids or cyclosporine within the past 3 months; 12. Known infection, massive bleeding, metabolic or endocrine disorders judged by the investigator; 13. Patients who have been included in other research studies; 14. Patients with active malignant tumors who need treatment; 15. Pregnant or breastfeeding women; 16. History of myocardial infarction or coronary revascularization; 17. Severely impaired CCTA at baseline or follow-up quality (severe artefacts present, undiagnosed); 18. Patient discontinued treatment during follow-up.

Design outcomes

Primary

MeasureTime frame
Changes of CT-FFR values 20mm away from patients with coronary vascular borderline lesions;

Secondary

MeasureTime frame
LDL-C;Changes of CT-FFR values within 20mm away from patients with coronary vascular borderline lesions vessel ends;Major adverse cardiovascular events;Adverse drug reaction events;

Countries

China

Contacts

Public ContactYang Qing

Tianjin Medical University General Hospital

cardio-yq@tmu.edu.cn+86 13911711189

Outcome results

None listed

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