Coronary disease & ACS

PCSK9 inhibitor added to high-intensity statin therapy to prevent cardiovascular events in patients with acute coronary syndrome after percutaneous coronary intervention: a randomized, double- blind, placebo-controlled, multicenter SHAWN study

Am Heart JPublished Randomised controlled trial

Study context

Population
Patients with acute coronary syndrome (ACS) and multiple lesions after percutaneous coronary intervention (PCI) for the culprit lesionplanned enrolment
Participants
1,212 patients
Planned comparison
PCSK9 inhibitor plus high-intensity statin vs high-intensity statin monotherapy
Primary endpoint
Composite of:
  • CV death
  • MI
  • Stroke
  • Re-hospitalisation due to ACS or HF
  • Any ischaemia-driven coronary revascularisation
Follow-up
1-year follow-up
Methodological detailsstudy protocol, double-blind, placebo-controlled, multicentre, stratified randomisation, Protocol only; no results reported, Safety endpoints: PCSK9 inhibitor and statin intolerance
  • Study protocol
  • Double-blind
  • Placebo-controlled
  • Multicentre
  • Stratified randomisation
  • Protocol only; no results reported
  • Safety endpoints: PCSK9 inhibitor and statin intolerance

No results yet. This paper sets out the design of a trial; its results are to come.

Original publication

PCSK9 inhibitor added to high-intensity statin therapy to prevent cardiovascular events in patients with acute coronary syndrome after percutaneous coronary intervention: a randomized, double- blind, placebo-controlled, multicenter SHAWN study. Am Heart J. Published 27 June 2024. doi:10.1016/j.ahj.2024.06.004

Summarised from the published abstract; every number is checked against it

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