Impact of PCSK9 Inhibitors on Coronary Plaque Composition and Vulnerability Assessed by Optical Coherence Tomography
Condition: Randomized Controlled Trials
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is a prospective, open-label, randomized, single-center study involving patients
      with intermediate coronary lesions (50%-70% diameter stenosis) and who have elevated LDL-C
      values (LDL-C≥100 mg/dL) despite stable statin therapy.

      Eligible patients are randomized to receive either alirocumab or standard-of-care (1:1). The
      last dose of alirocumab will be given at week 34. Patients in the alirocumab arm will receive
      alirocumab 75 mg Q2W added to statin therapy (atorvastatin 20 mg/day or rosuvastatin
      10mg/day). Patients in the standard-of-care arm will continue to receive atorvastatin 20
      mg/day or rosuvastatin 10 mg/day. OCT images will be acquired at the baseline and at week 36
      ± 2 weeks follow-up.
    

Detailed description: 
      The study is a prospective, open-label, randomized, single-center study involving patients
      with intermediate coronary lesions (50%-70% diameter stenosis) and who have elevated LDL-C
      values (LDL-C≥100 mg/dL) despite stable statin therapy.

      Eligible patients included those who are (I) at least 18 years of age, (II) diagnosed as
      stable coronary artery disease or acute coronary syndrome during admission (III) undergoing
      clinically indicated coronary angiography and identified with at least one intermediate
      lesion (50%-70% diameter stenosis) on de novo coronary arteries, (IV) have an elevated LDL-C
      values (LDL-C≥100 mg/dL) despite taken rosuvastatin 10 mg/day or atorvastatin 20 mg/day for
      2-4 weeks after initiation or with maximally tolerated statin therapy, (V) able to provide
      written, informed consent.

      The study included a 36-week open-label treatment period (including post-treatment OCT
      imaging), starting within 4 weeks of baseline coronary angiogram. During the open-label
      treatment period, patients are randomized to receive either alirocumab or standard-of-care
      (1:1). The last dose of alirocumab will be given at week 34.

      Patients in the alirocumab arm will receive alirocumab 75 mg Q2W added to statin therapy
      (atorvastatin 20 mg/day or rosuvastatin 10mg/day). Patients in the standard-of-care arm will
      continue to receive atorvastatin 20 mg/day or rosuvastatin 10 mg/day. Statin dose escalation
      or adding concomitant non-statin lipid-lowering therapy would be considered by their
      responsible physician to achieve an LDL-C target <100 mg/dL. Antithrombotic therapy and other
      concomitant medications are exclusively decided by the responsible physicians. Follow-up
      coronary angiograms and OCT imaging analyses of the same vessels will be carried out at the
      end of treatment period (at week 36 ± 2 weeks, depending on patient availability) in both
      study arms. Regular medical examination and laboratory tests will be conducted at weeks 4,
      12, 24, and 36. All enrolled patients are monitored and evaluated for safety and any other
      adverse events during the study period.
    

Intervention name(s): PCSK9 inhibitor plus statin; standard statin therapy; Coronary imaging follow-up
Intervention type(s): Drug; Drug; Procedure
Intervention description(s): Patients in the alirocumab arm will receive alirocumab 75 mg Q2W added to statin therapy (atorvastatin 20 mg/day or rosuvastatin 10mg/day).; Patients will continue to receive atorvastatin 20 mg/day or rosuvastatin 10 mg/day.; coronary angiography and OCT imaging at week 36 ± 2 weeks follow-up
Other intervention name(s): alirocumab
Intervention MeSH terms: Hydroxymethylglutaryl-CoA Reductase Inhibitors; Alirocumab; PCSK9 Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment