OCEAN(a)-Outcomes – Olpasiran trials of Cardiovascular Events And LipoproteiN(a) reduction – Outcomes trial

Phase 1

• Conditions: Cardiovascular disease (atherosclerotic cardiovascular disease (ASCVD) and elevated lipoprotein (a)); MedDRA version: 21.1Level: LLTClassification code: 10051614Term: Arteriosclerotic cardiovascular disease Class: 10047065; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2022-501608-85-00
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-09
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 6698

Inclusion Criteria

Subject has provided informed consent prior to initiation of any study specific activities/procedures, Age 18 to = 85 years (or = legal age within the country if it is older than 18 years) at signing of informed consent, Lp(a)= 200 nmol/L during screening by central laboratory •At least = 2 weeks of stable, and optimized lipid-lowering therapy consistent with regional/local clinical practice guidelines according to investigator’s judgment prior to Screening Lp(a)., History of ASCVD as evidenced by history of either: •Myocardial infarction (MI) (presumed type 1 event due to plaque rupture/erosion) and/or •Coronary revascularization by percutaneous coronary intervention (PCI) AND any of the following: -Age = 65 years -Residual coronary artery stenosis >50% in any major vessel (including major branches) -Multivessel PCI (ie, = 2 distinct vessels including branch arteries) -Symptomatic peripheral arterial disease with either (a) intermittent claudication with ankle-brachial index (ABI) < 0.85, or (b) peripheral arterial revascularization or amputation due to atherosclerotic disease -Ischemic stroke (presumed atherosclerotic in origin) -Diabetes mellitus (type 1 or type 2)

Exclusion Criteria

Severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 by central laboratory during screening, Atrial fibrillation or flutter not on an anticoagulant despite an indication to be anticoagulated., Uncontrolled hypertension at screening, defined as systolic blood pressure > 180 mmHg or diastolic blood pressure >110 mmHg at rest despite antihypertensive therapy, Fasting triglycerides > 400 mg/dL (4.52 mmol/L) during screening, Poorly controlled diabetes mellitus (type 1 or type 2), defined as HbA1c > 10% by central laboratory at screening, Known major active infection, or a chronic disease or infection (eg, human immunodeficiency virus) that is not currently stable and appropriately managed in the judgment of the investigator, Current or planned lipoprotein apheresis or < 3 months since last apheresis treatment prior to study day 1, Subject has taken lomitapide in the last 12 months prior to study day 1, Changes in lipid lowering therapy after Lp(a) screening or within 4 weeks prior to day 1, Previously received RNA therapy specifically targeting Lp(a), eg, olpasiran or pelacarsen, Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN), or total bilirubin (TBL) > 2 x ULN during screening, History of hemorrhagic stroke, History of major bleeding disorder (for example: hemophilia, von Willebrand disease, clotting factor deficiencies, etc), Major cardiovascular event (eg, myocardial infarction, unstable angina, PCI, coronary artery bypass graft, or stroke) within 4 weeks prior to Lp(a) screening or during screening, Planned cardiac surgery or arterial revascularization, Malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma) within the last 5 years prior to study day 1, Diagnosis of severe heart failure (New York Heart Association Functional Classification IV, and/or if available, most recent left ventricular ejection fraction < 30%), Uncontrolled or recurrent ventricular tachycardia in the past 3 months prior to study day 1

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified