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

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

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

Treatments tested in this trial

  • PCSK9 inhibitors and background lipid-modifying therapy
  • Standard lipid-modifying therapy

Treatment groups

3,596 Participants
are divided into 2 treatment groups

Locations

6
China
Zhejiang Provincial Hospital of Traditional Chinese Medicine HangzhouZhejiang, China
Hangzhou Linping First People's Hospital Hangzhou China
The Second Affiliated Hospital, School of Medicine, Zhejiang University Hangzhou China
Zhejiang Hospital Hangzhou China

Sponsors and collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor