ClinicaliQ Trial Snapshot
- A Phase III Study of AZD0780 on Major Adverse CV Events in Patients With a History of ASCVD Events or at High Risk for a First Event — Recruiting • Phase III • Cardiology / Cardiovascular • NCT07000357.
- What is being tested: AZD0780, an oral PCSK9 inhibitor, is being evaluated in a Phase III randomized controlled trial to assess its efficacy in reducing major adverse cardiovascular events (MACE-PLUS) compared with placebo.
- Patient eligibility overview: The study enrolls patients with either established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first cardiovascular event, representing a broad secondary and primary prevention population.
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What This Trial Is Studying
The purpose of this phase 3, randomized, placebo controlled, event-driven study is to assess the effect of AZD0780, an oral PCSK9 inhibitor, compared with placebo in reducing the risk of MACE-PLUS in patients with established ASCVD or at high risk for a first ASCVD event. The effect of AZD0780 vs placebo on the risk of MACE-PLUS will be evaluated from randomisation until the primary analysis censoring date (PACD). The Study Closure Visit will be scheduled to occur after the PACD and will be the final visit for each participant in…
Eligibility Snapshot
- : * Meets one of the following:
- Participants with history of an ASCVD event: Participants ≥ 18 years of age at the time of signing the ICF with a history of MI or ischaemic stroke suspected to be due to atherosclerotic vascular disease ≥ 1 month prior to randomisation (presumed lacunar or cardioembolic strokes are not qualifying events), or revascularisation for symptomatic lower limb PAD any time prior to screening Additional risk factors based on the level of the LDL-C and timing of MI or stroke: o Participants with an LDL-C ≥ 75 mg/dL (≥ 1.9 mmol/L) need to have at least one of the other additional risk factors (i to viii) below. ii) T2DM requiring ongoing medical therapy iii) Age ≥ 65 years v) Previous above ankle amputation due to PAD vi) Previous diagnosis of non-end stage CKD
- Participants at increased risk of a first ASCVD event: Male participant ≥ 50 years of age or female participant ≥ 55 years of age at the time of signing the ICF with LDL-C ≥ 100 mg/dL (≥ 2.6 mmol/L), with no prior history of MI, ischaemic stroke due to atherosclerotic disease, or leg revascularisation for symptomatic lower limb…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.