The Safety and Long-Term Clinical Benefit of PCSK9i in STEMI Patients

Sponsor
Hamad Medical Corporation
Study ID
NCT05579418
Phase
PHASE4
Status
Unknown

Conditions

  • Dyslipidemias
  • STEMI

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Evolocumab — DRUG
    Evolocumab is an injection for management of dyslipidemia

Study Details

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.

Key Dates

Start date
Nov 1, 2022
Status verified
Oct 2022
Primary completion
Oct 30, 2024
Completion
Oct 30, 2024

Study Design

Enrollment
350 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Interventional Arm
    Patient that qualify for the trial will be randomized for receiving the PCSK9i injection in addition to the standard medical therapy.
  • No Intervention: Control Arm
    Patient will only receive the standard medical therapy, No PCSK9i

Primary Outcome Measure

Major cardiovascular events, defined as the composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. [ Time Frame: 12 months ]

Central Contacts

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