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Further Lipid-Lowering With PCSK9 Inhibitors for Cardiovascular Outcomes in High-Risk Coronary Plaques Assessed by CT Angiography

ConditionsCoronary Artery DiseaseCT AngiographyPCSK9Cardiovascular Events
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

The primary objective was to evaluate the effect of PCSK9 inhibitors in addition to the background lipid-modifying therapy (LMT), compared with standard LMT in terms of clinical outcomes in patients with coronary CT angiography (CCTA)-detected high-risk plaques.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject must be ≥ 18 years.

Degree of stenosis ≥ 50% or plaque burden ≥ 70%

The target lesion is located at the proximal or mid segment of left anterior descending artery, left circumflex artery or right coronary artery.

Subject is able to confirm his/her understanding of the risks, benefits, and treatment alternatives of receiving study-related treatment. He/she or his/her legally authorized representative provides written informed consent prior to any study-related procedure.

Disqualifiers

Target lesions underwent or planned to revascularization.

Patients with acute coronary syndrome.

New York Heart Association class III or IV, or last known left ventricular ejection fraction < 30%.

Uncontrolled or recurrent ventricular tachycardia.

Trial design

Design model

Parallel

Treatments tested in this trial

  • PCSK9 inhibitors and background lipid-modifying therapy

    Drug

    Patients will receive subcutaneous injections of PCSK9 inhibitors and oral administration of background LMT (including statins and/or cholesterol absorption inhibitors) for the first 12 months after randomization, with PCSK9 inhibitors administered every 2 weeks. After the first 12 months, patients will discontinue the PCSK9 inhibitors but continue background LMT for the remainder of the trial.

  • Standard lipid-modifying therapy

    Drug

    Patients will receive standard LMT commonly used in clinical practice.

Treatment groups

3,596 Participants
are divided into 2 treatment groups
Group A: PCSK9 inhibitors plus background lipid-modifying therapyExperimental treatment 0 interventions
Group B: Standard lipid-modifying therapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Major adverse cardiac and cerebrovascular events (MACCEs)

A composite of death from any cause, myocardial infarction (MI), coronary revascularization, or stroke.

Time frame
24 months after the last patient's randomization

Secondary outcomes

1

MACCEs

a composite of death from any cause, MI, coronary revascularization, or stroke.

Time frame
60 months after the last patient's randomization
2

Individual component of MACCEs.

Individual component of MACCEs (death from any cause, MI, coronary revascularization, or stroke)

Time frame
24 and 60 months after the last patient's randomization
3

Major adverse cardiovascular events (MACEs)

Defined as a composite of death from any cause, MI, coronary revascularization.

Time frame
24 and 60 months after the last patient's randomization
4

Target vessel failure (TVF)

Defined as a composite of cardiac death, target-vessel MI, or target vessel revascularization

Time frame
24 and 60 months after the last patient's randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Source ClinicalTrials.gov
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