Impact of PCSK9 Inhibitors on Coronary Plaque Composition and Vulnerability Assessed by Optical Coherence Tomography

NCT04851769 | Completed Phase 4 DMC

• 1 other identifier: anzhen201803
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Randomized Controlled Trials

Outcome Measures

Primary Outcomes (1)

• minimum fibrous-cap thickness

  The primary endpoint of the study is the OCT derived changes in minimum fibrous-cap thickness between baseline and follow-up.

  36 weeks

Secondary Outcomes (1)

• minimum lumen area and maximum lipid arc

  36 weeks

Study Arms (2)

alirocumab plus statin

EXPERIMENTAL

Patients in the alirocumab arm will receive alirocumab 75 mg Q2W added to statin therapy (atorvastatin 20 mg/day or rosuvastatin 10mg/day).

Drug: PCSK9 inhibitor plus statin; Procedure: Coronary imaging follow-up

standard statin therapy

ACTIVE COMPARATOR

Patients in the standard statin 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 could be considered by their responsible physician to achieve an LDL-C target \<100 mg/dL.

Drug: standard statin therapy; Procedure: Coronary imaging follow-up

Interventions

PCSK9 inhibitor plus statin DRUG

Patients in the alirocumab arm will receive alirocumab 75 mg Q2W added to statin therapy (atorvastatin 20 mg/day or rosuvastatin 10mg/day).

Also known as: alirocumab

alirocumab plus statin

standard statin therapy DRUG

Patients will continue to receive atorvastatin 20 mg/day or rosuvastatin 10 mg/day.

standard statin therapy

Coronary imaging follow-up PROCEDURE

coronary angiography and OCT imaging at week 36 ± 2 weeks follow-up

alirocumab plus statin; standard statin therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (I) 18 - 80 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.

You may not qualify if:

• Patients who have been treated previously with at least one dose of any anti-PCSK9 monoclonal antibody
• received target vessel revascularization
• Known hypersensitivity or have contraindications to any anti-PCSK9 monoclonal antibody or statins
• Unable to receive OCT imaging tests
• Known history of hemorrhagic stroke
• Currently under treatment for cancer
• Baseline triglyceride \> 400 mg/dl
• Patients with severe liver or renal dysfunction
• Pregnant or breast-feeding women
• Considered by the investigator as inappropriate for this study for any reason

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

Location

Related Publications (2)

• Gao F, Li YP, Ma XT, Wang ZJ, Shi DM, Zhou YJ. Effect of Alirocumab on Coronary Calcification in Patients With Coronary Artery Disease. Front Cardiovasc Med. 2022 May 6;9:907662. doi: 10.3389/fcvm.2022.907662. eCollection 2022.

  PMID: 35600486 DERIVED

• Gao F, Wang ZJ, Ma XT, Shen H, Yang LX, Zhou YJ. Effect of alirocumab on coronary plaque in patients with coronary artery disease assessed by optical coherence tomography. Lipids Health Dis. 2021 Sep 12;20(1):106. doi: 10.1186/s12944-021-01528-3.

  PMID: 34511134 DERIVED

MeSH Terms

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors; alirocumab

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Officials

• Yujie Zhou, MD

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president, professor

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 20, 2021
• Study Start: March 2, 2019
• Primary Completion: January 28, 2021
• Study Completion: March 1, 2021
• Last Updated: April 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)