SELATOGREL for Acute myocardial infarction

Inclusion criteria

• {"criterion_text":"- Signed and dated informed consent prior to any study-mandated procedure.\n- Male or female subject ≥ 18 years old at the time of signing the informed consent form.\n- Confirmed diagnosis of symptomatic Type 1 acute myocardial infarction ST-elevation myocardial infarction (STEMI) or Non-ST-elevation myocardial infarction (NSTEMI), no longer than 4 weeks prior to randomization.\n- Diagnosis of multivessel coronary artery disease defined as ≥ 50% stenosis on 2 or more coronary artery territories, including the left main artery, during a prior cardiac catheterization or cardiac catheterization during the qualifying AMI event and presence of at least 1 of the following risk factors: - Second prior AMI, - Diabetes mellitus defined by ongoing glucose lowering treatment, - CKD defined as eGFR < 60 mL/min/1.73 m2 and either known history of CKD or a biomarker of chronic kidney damage,, - Peripheral artery disease at any time prior to randomization, - Absence of, or unsuccessful coronary revascularization of the qualifying AMI.\n- Successfully self-administered placebo according to the autoinjector Instructions for use during screening."}

Exclusion criteria

• {"criterion_text":"- Increased risk of serious bleeding including any of the following: - History of intracranial bleed at any time. - Known uncorrected intracranial vascular abnormality. - Gastrointestinal bleed requiring hospitalization or transfusion within 1 year prior to screening. - Already on oral triple antithrombotic therapy (i.e., Dual antiplatelet therapy and oral anticoagulant). - Known liver impairment significantly affecting the hepatic function. - Current dialysis. - For all countries, except Finland: Ischemic stroke or transient ischemic attack within 3 months prior to screening. For Finland: Ischemic stroke or transient ischemic attack within 1 year prior to screening.\n- Chronic anemia with hemoglobin 10 g/dL.\n- Chronic thrombocytopenia with platelet count 100,000/mm3.\n- Concomitant diseases or conditions that, in the opinion of the investigator, are not compatible with study participation.\n- Known hypersensitivity to selatogrel, any of its excipients, or drugs of the P2Y12 class.\n- Previous exposure to an investigational drug within 3 months prior to randomization.\n- Participation in another clinical trial with an investigational product or device within 3 months prior to randomization."}

Primary endpoints

• {"endpoint_text":"- Efficacy: Occurrence of death or non-fatal AMI after any study treatment self-administration. The outcome will be ranked from most to least severe: 1. Death (all causes)* 2. AMI with compromised electro-hemodynamics** 3. STEMI** 4 .High-risk NSTEMI** 5. NSTEMI with peak cardiac troponin > 10 × upper limit of normal** 6. None of the above within *7/**2 days after each treatment administration Only the worst outcome will be retained as the primary endpoint.","definition_or_measurement_approach":"Composite, ranked outcome. Occurrence of death or non-fatal AMI categorized and ranked from most to least severe; only the worst outcome per administration retained. Time window: within 7 or 2 days after each treatment administration as specified (*7/**2 days)."}
• {"endpoint_text":"- Safety: Occurrence of type 3 or 5 treatment-emergent bleeding events according to the Bleeding Academic Research Consortium (BARC) definition, within 2 days after study treatment administration.","definition_or_measurement_approach":"Bleeding events classified using BARC definitions; primary safety endpoint counts treatment-emergent BARC type 3 or type 5 events occurring within 2 days after administration."}

Secondary endpoints

• {"endpoint_text":"- Occurrence of death, non-fatal AMI, hospitalization or unplanned emergency department visit for heart failure, within 30 days after any treatment administration (composite endpoint).","definition_or_measurement_approach":"Composite endpoint measured as occurrence of any listed event within 30 days after any treatment administration."}

Primary sponsor

Full Name

Viatris Innovation GmbH

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

IQVIA Limited

Responsibilities

Management of study start-up activities, site management, eTMF maintenance, investigators payments and reimbursements.

Name

Imperial Clinical Research Services International Ltd.

Responsibilities

Fulfillment company (printing & kitting of patient training and awareness materials).

Name

Next CRO SYMVOULOI FARMAKEUTIKON EPICHEIRISEON M.E.P.E.

Responsibilities

Site contracting and local site support; contact for contracts with hospitals and investigators.

Name

Precision for Medicine (HU) Kft.

Responsibilities

Project management, contact for contracts with hospitals, investigators, other parties as required.

Name

Winicker-Norimed Medizinische Forschung GmbH

Responsibilities

Project support and study management assistance.

Name

Almac

Responsibilities

Supply/logistics related duties.

Third parties

• {"country":"Finland","full_name":"Oriola Finland Oy","duties_or_roles":"Project Management, Contract/agreements; contact: clinical.services@oriola.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Imperial Clinical Research Services International Ltd.","duties_or_roles":"Fulfillment company (printing & kitting of patient training and awareness materials); contact: connect@imperialcrs.com","organisation_type":"Pharmaceutical company"}
• {"country":"Greece","full_name":"Next CRO SYMVOULOI FARMAKEUTIKON EPICHEIRISEON M.E.P.E.","duties_or_roles":"Project management, contact for contracts with hospitals, investigators, other parties as required; site management","organisation_type":"Pharmaceutical company"}
• {"country":"Hungary","full_name":"Precision for Medicine (HU) Kft.","duties_or_roles":"Project management, contact for contracts with hospitals, investigators, other parties as required; regulatory contact (RegulatoryEU@precisinformedicine.com)","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Management of study start-up activities, site management, eTMF maintenance, investigators payments and reimbursements; contact: eu_clinical_trials_information@iqvia.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Omnitrace Corp.","duties_or_roles":"Participant locator services; contact: info@omnitrace.com","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Socar Research S.A.","duties_or_roles":"Investigator payments; contact: admin@socar.ch","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Enzyme Communications Limited","duties_or_roles":"Development of patient and site support materials; contact: hello@enzymecomms.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Stanford University","duties_or_roles":"Clinical event adjudication","organisation_type":"Educational Institution"}
• {"country":"Switzerland","full_name":"Acolad Switzerland AG","duties_or_roles":"Translation of training material","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Germany","full_name":"DATAMAP-Gesellschaft fuer Datenmanagement Datenanalyse und Datenpraesentation mbH","duties_or_roles":"Independent Statistical Analysis Center","organisation_type":"Non-Pharmaceutical company"}
• {"country":"France","full_name":"Action-Coeur Allies In Cardiovascular Trial Initiatives And Organized Networks Coeur","duties_or_roles":"Feasibility, site engagement","organisation_type":"Educational Institution"}
• {"country":"United States","full_name":"Almac","duties_or_roles":"Supply/logistics (code 3 duty listed)","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Winicker-Norimed Medizinische Forschung GmbH","duties_or_roles":"Project support (listed duties include code 1)","organisation_type":"Pharmaceutical company"}
• {"country":"Hungary","full_name":"Da Vinci Spa Kft.","duties_or_roles":"Site-related duties (listed as a participating organisation in sites list)","organisation_type":"Pharmaceutical company"}