Effect of Small Interfering RNA Inclisiran on Carotid Plaques As Assessed by Carotid Ultrasound

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFirst Affiliated Hospital of Xinjiang Medical University

About this trial

Current understanding suggests that the majority of cardiovascular events are driven by vulnerable plaques. Nonetheless, the impact of PCSK9 inhibitors on the stability of carotid plaques remains insufficiently elucidated, with a notable scarcity of relevant clinical studies. This investigation seeks to address this gap through a real-world study conducted among patients with arterial sclerosis in Asia. The primary aim is to evaluate the effects of small interfering RNA (inclisiran) on carotid plaque characteristics as assessed by ultrasound, thereby contributing valuable data to inform clinical practice.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with carotid plaques as indicated by ultrasound

Men and women aged 18-75 years;

LDL-C >3.4 mmol/L without regular statin therapy or LDL-C >1.8 mmol/L after 4 weeks of statin lipid-lowering therapy.

Disqualifiers

- Known allergies or contraindications to PCSK9 inhibitors and/or statin therapy;

Prior use of PCSK9 inhibitors;

Prior history of hemorrhagic stroke;

Prior coronary artery bypass grafting or coronary intervention;

Trial design

Design model

Single group

Treatments tested in this trial

  • Inclisiran

    Drug

    Patients with carotid plaques undergoing treatment with inclisiran

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: inclisiran Therapy groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

CIMT

Carotid artery intima media thickness

Time frame
Immediately and treated with inclisiran one year later
2

TMPT

The maximal plaque thickness

Time frame
Immediately and treated with inclisiran one year later
3

CPA

Carotid plaque area

Time frame
Immediately and treated with inclisiran one year later
4

CPV

Carotid plaque volume

Time frame
Immediately and treated with inclisiran one year later

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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