olpasiran for Atherosclerotic cardiovascular disease | Elevated lipoprotein(a)

Inclusion criteria

• {"criterion_text":"- Participant has provided written informed consent before initiation of any studyspecific activities/procedures."}
• {"criterion_text":"- Age ≥ 50 years at the time of signing of the Lp(a) screening ICF."}
• {"criterion_text":"- Lp(a) ≥ 200 nmol/L during Lp(a) screening by a central laboratory using an investigational IVD test. - At least 4 weeks of stable and optimized lipid-lowering therapy consistent with regional/local clinical practice guidelines or according to investigator’s judgment before Lp(a) screening."}
• {"criterion_text":"- Participants meeting at least one of the following categories (A or B): A. Multiple risk factors for atherosclerotic disease AND/OR B. History of atherosclerosis"}

Exclusion criteria

• {"criterion_text":"- Prior acute atherothrombotic qualifying event at any time, defined as prior myocardial infarction, prior stroke, prior transient ischemic attack, or prior acute limb ischemia."}
• {"criterion_text":"- Prior arterial revascularization at any time suspected to be associated with atherosclerosis."}
• {"criterion_text":"- History of major bleeding disorder (eg, hemophilia, von Willebrand disease, clotting factor deficiencies, etc)."}
• {"criterion_text":"- Planned arterial revascularization (percutaneous or surgical)."}
• {"criterion_text":"- Fasting triglycerides > 400 mg/dL (4.52 mmol/L) during screening."}

Primary endpoints

• {"endpoint_text":"- Time to CHD death, myocardial infarction, or urgent coronary revascularization, whichever occurs first","definition_or_measurement_approach":"Time-to-event composite endpoint measuring the time until occurrence of coronary heart disease (CHD) death, myocardial infarction, or urgent coronary revascularization (whichever occurs first)."}

Secondary endpoints

• {"endpoint_text":"- Time to cardiovascular death, myocardial infarction, or ischemic stroke, whichever occurs first","definition_or_measurement_approach":"Time-to-event composite endpoint measuring time until cardiovascular death, myocardial infarction, or ischemic stroke (whichever occurs first)."}
• {"endpoint_text":"- Time to cardiovascular death, myocardial infarction, urgent coronary revascularization, or ischemic stroke, whichever occurs first","definition_or_measurement_approach":"Time-to-event composite endpoint measuring time until cardiovascular death, myocardial infarction, urgent coronary revascularization, or ischemic stroke (whichever occurs first)."}
• {"endpoint_text":"- Percent change from baseline to week 48 Lp(a) levels","definition_or_measurement_approach":"Laboratory measurement of Lp(a) levels at baseline and at week 48; endpoint is percent change from baseline to week 48."}

Methods

• Physician referral letters (physician-to-physician referral letters) - used as recruitment channel to refer potentially eligible patients to study sites (country-specific physician referral letters are included in the submission packages).
• Clinic wall posters displayed at investigational sites/clinic waiting areas (documents titled 'Clinic Wall Poster') to raise awareness among clinic visitors and potential participants (country-specific poster versions provided).
• Educational brochures about Lp(a) and the study provided to potential participants and clinics (documents titled 'Educational Brochure').
• GP/primary care letters and GP outreach (GP letters) to inform community clinicians and request referrals of eligible patients.
• Site-level materials such as patient appointment cards, thank-you letters and study visit guides to support recruitment and retention.

Primary sponsor

Full Name

Amgen Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Iqvia Rds Inc.

Responsibilities

Code 1 duties (listed as sponsorDuties: 1)

Name

Syngene International Limited

Responsibilities

Code 4 duties (listed as sponsorDuties: 4)

Name

Altasciences Compagnie Inc.

Responsibilities

Code 4 duties (listed as sponsorDuties: 4)

Name

Azenta US Inc.

Responsibilities

Code 4 duties (listed as sponsorDuties: 4)

Name

Labcorp Central Laboratory Services SARL

Responsibilities

Code 4 duties (listed as sponsorDuties: 4)

Name

Medidata Solutions Inc.

Responsibilities

Code 7 duties (listed as sponsorDuties: 7)

Name

Suvoda LLC

Responsibilities

Code 3 duties (listed as sponsorDuties: 3)

Third parties

• {"country":"India","full_name":"Syngene International Limited","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"sponsorDuties codes: 1","organisation_type":"Pharmaceutical company"}
• {"country":"Canada","full_name":"Altasciences Compagnie Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"The Brigham And Women’s Hospital Inc.","duties_or_roles":"Scientific consultancy and Event adjudication","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United Kingdom","full_name":"Publicis Healthcare Communications Group Limited","duties_or_roles":"Investigator Recruitment Development of Recruitment Tools","organisation_type":"Non-Pharmaceutical company"}
• {"country":"France","full_name":"Kayentis","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"France","full_name":"Quipment","duties_or_roles":"Provision of study equipment (eg. Freezers) to investigational sites","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"TIMI at The Brigham And Women’s Hospital Inc.","duties_or_roles":"Scientific consultancy and Event adjudication (listed under third parties with email TIMI@partners.org)","organisation_type":"Hospital/Clinic/Other health care facility"}