At a glance
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Further Lipid-Lowering With PCSK9 Inhibitors for Cardiovascular Outcomes in High-Risk Coronary Plaques Assessed by CT Angiography
In Brief
A clinical study evaluating PCSK9 inhibitors and background lipid-modifying therapy and Standard lipid-modifying therapy for Coronary Artery Disease and 3 related conditions. Currently recruiting, targeting 3,596 participants across 6 sites in 2 countries.
Signals
Detailed Summary
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.
Study Details
Timeline
Interventions
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.
Patients will receive standard LMT commonly used in clinical practice.