The Safety and Long-Term Clinical Benefit of PCSK9i in STEMI Patients
Status:
Not yet recruiting
Trial end date:
2024-10-30
Target enrollment:
Participant gender:
Summary
Patients with acute coronary syndromes (ACS) have an increased risk of recurrent ischemic
events, particularly during the first year following the index event, which is mainly due to
unattended risk factors and/ or poor compliance with medications. Lowering low-density
lipoprotein cholesterol (LDL-C) reduces cardiovascular morbidity and mortality in patients
with atherosclerotic cardiovascular disease (ASCVD), with a magnitude of clinical benefit
that is proportional to the reduction in LDL-C levels. Proprotein convertase subtilisin/
kexin type 9 (PCSK9) antibodies have emerged as a new class of drugs that rapidly and
effectively lower LDL-C levels up to 77 % of the original value in combination with statins.
The primary objective of this study is to confirm the safety and the long-term clinical
benefit associated with the use of PCSK9i when combined with statin in patients with
ACS-STEMI.
The study is an investigator-initiated, prospective, randomized, open label study that will
be the first study looking for the safety and the clinical benefit and outcome associated
with the use of PCSK9i in ACS-STEMI patients specifically. Internationally, this will be the
first trial studying the effect of PCSK9i on patients with acute myocardial infarction
(STEMI) in terms of reduction in cholesterol level and reduction in cardiac events rate
(re-infarction and cardiac death) after myocardial infarction. This trial will have a
significant impact in the management of patients with STEMI, locally and internationally and
it will be conducted purely in Qatar. This trial will help to improve the clinical outcome of
patients in Qatar in terms of reduction of myocardial reinfarction rate and mortality.