A medical research study to evaluate the effects of a new drug called Selatogrel in adult patients with a heart attack
Résumé de l'étude
This study investigates the efficacy and safety of self-administered subcutaneous Selatogrel for the prevention of overall mortality and treatment of acute myocardial infarction in patients with a recently suffered acute myocardial infarction. In this study, Selatogrel and placebo are examined. One of the two medications will be given in addition to the regular medical care for the heart attack. The study drug (Selatogrel or placebo) will be provided in ready-to-use auto-injectors. Each study auto-injector can only be used once and contains either 16 mg of Selatogrel or a placebo. Half of the participants will receive study auto-injectors containing Selatogrel. The other half of the participants will receive study auto-injectors containing a placebo. This will be determined randomly, like flipping a coin, using a computer. Participants have about a 50% chance (1 in 2 chance) of receiving study auto-injectors with Selatogrel. A placebo looks like the real study drug but contains no active ingredient. It is important to compare Selatogrel with a placebo to find out if Selatogrel really works. This is a double-blind study. This means that neither the participants nor their investigator know whether the Selatogrel-containing study auto-injectors or placebo is administered. The duration of participation in the study is not known in advance and varies from patient to patient. Participation can last from about 6 months to about 2.5 years and includes a pre-assessment period (during which participants learn how to administer the auto-injector and how to recognize a heart attack), an observation period (during which participants will be contacted several times by phone) and a final visit.
(BASEC)
Intervention étudiée
Approximately 14,000 people worldwide will be assigned to these groups in a 1:1 ratio:
- Selatogrel group: Auto-injector filled with 16 mg of Selatogrel for subcutaneous injection in case of heart attack symptoms
- Placebo group: Auto-injector filled with placebo for subcutaneous injection in case of heart attack symptoms
(BASEC)
Maladie en cours d'investigation
Acute myocardial infarction
(BASEC)
1. Dated and fully signed statement of participation in the clinical study before the first study-related measure is taken; 2. Female or male study participants aged 18 years or older at the time of signing the consent statement; 3. Diagnostically confirmed symptomatic type 1 myocardial infarction (STEMI or NSTEMI) not longer than 4 weeks before the time of randomization. 4. Diagnosis of multivessel coronary artery disease, defined as ≥ 50% stenosis in 2 or more coronary artery territories or in the left main artery during a previous coronary angiography or a coronary angiography during the qualifying AMI event and presence of at least 2 risk factors. 5. The patient was successfully able to self-administer the placebo independently according to the instructions for use of the auto-injector. 6. Women of childbearing potential who meet the following criteria: – Negative pregnancy test in urine or serum at randomization. – Consent to use an acceptable method of contraception from the screening period until the last study visit (FSV). (BASEC)
Critères d'exclusion
1. Increased risk of serious bleeding including any of the following described: a. Intracranial bleeding at any time in the past. b. Known uncorrected intracranial vascular abnormality. c. Gastrointestinal bleeding within one year prior to screening that required hospitalization or transfusion. d. Patients receiving an oral triple therapy for thrombotic prophylaxis (e.g., dual antiplatelet therapy along with oral anticoagulation therapy). e. Known liver insufficiency with significant impairment of liver function (e.g., ascites, jaundice, signs of coagulopathy). f. Acute dialysis. g. Ischemic stroke or transient ischemic attack within 3 months prior to screening. 2. Chronic anemia with a hemoglobin level of < 10 g/dL. 3. Chronic thrombocytopenia with a platelet count of < 100,000/mm3. 4. Any comorbidity (e.g., mental illness, significant cognitive deficits, neurodegenerative diseases, terminal malignant tumors, etc.) or circumstances (e.g., inability to communicate sufficiently well with the investigator in the local language, unwillingness to follow study requirements or to take actions within the study, inability to understand study-specific instructions, vulnerable person, etc.) that in the opinion of the investigator are not compatible with participation in this study. 5. Known hypersensitivity to Selatogrel and/or any of the components of the study drug or to substances of the P2Y12 class. 6. Exposure to a study drug within 3 months prior to randomization. 7. Participation in another clinical trial with an experimental drug or an experimental medical device within 3 months prior to randomization. 8. Pregnancy, planning to become pregnant or breastfeeding women. 9. Known life-threatening comorbidities with a life expectancy of < 12 months. (BASEC)
Lieu de l’étude
Bâle, Berne, Lugano, St-Gall
(BASEC)
Sponsor
Idorsia Pharmaceuticals Ltd, Allschwil
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Prof. Dr. med. Christian Müller
+41 (0)61 328 68 16
Christian.Mueller@clutterusb.chUniversitätsspital Basel, Kardiologie
(BASEC)
Informations générales
Idorsia Pharmaceuticals Ltd.
(ICTRP)
Informations scientifiques
Idorsia Pharmaceuticals Ltd.
(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Date d'approbation du comité d'éthique
06.10.2021
(BASEC)
Identifiant de l'essai ICTRP
NCT04957719 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Multi-center, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of self-administered subcutaneous selatogrel for prevention of all-cause death and treatment of acute myocardial infarction in subjects with a recent history of acute myocardial infarction (BASEC)
Titre académique
Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Self-administered Subcutaneous Selatogrel for Prevention of All-cause Death and Treatment of Acute Myocardial Infarction in Subjects With a Recent History of Acute Myocardial Infarction (ICTRP)
Titre public
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction (ICTRP)
Maladie en cours d'investigation
Acute Myocardial Infarction (ICTRP)
Intervention étudiée
Combination Product: SelatogrelCombination Product: Placebo (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). (ICTRP)
Critères d'inclusion/exclusion
Main Inclusion Criteria:
- Confirmed diagnosis of symptomatic type 1 acute myocardial infarction (AMI)
ST-Elevation Myocardial Infarction (STEMI) or Non-ST-Elevation Myocardial Infarction
(NSTEMI), no longer than 4 weeks prior to randomization.
- Diagnosis of multivessel coronary artery disease defined as = 50% stenosis on 2 or
more coronary artery territories or on the left main artery during a prior cardiac
catheterization or cardiac catheterization during the qualifying AMI event and
presence of at least 2 of the following risk factors:
- Second prior AMI,
- Diabetes mellitus defined by ongoing glucose lowering treatment,
- Chronic kidney disease with estimated glomerular filtration rate less-than 60
mL/min/1.73 m2,
- Peripheral artery disease at any time prior to randomization,
- Absence of, or unsuccessful coronary revascularization of the qualifying AMI.
- Successful self-administered placebo according to the autoinjector instruction for
use training during screening.
Main Exclusion Criteria:
- 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.
- Ischemic stroke or transient ischemic attack within 3 months of screening.
- Chronic anemia with hemoglobin < 10 g/dL.
- Chronic thrombocytopenia with platelet count < 100,000/mm3.
- Known hypersensitivity to selatogrel, any of its excipients, or drugs of the P2Y12
class.
- Previous exposure to an investigational drug within 3 months prior to randomization.
- Participation in another clinical trial with an investigational product or device
within 3 months prior to randomization. (ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
Clinical status as assessed by a 6-point ordinal scale;Occurrence of Type 3 or 5 treatment-emergent bleeding events according to the Bleeding Academic Research Consortium (BARC) definition (ICTRP)
Occurrence of death, non-fatal acute myocardial infarction, hospitalization or unplanned emergency department visit for heart failure (Composite endpoint) (ICTRP)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
Clinical Trials, Idorsia Pharmaceuticals Ltd. (ICTRP)
ID secondaires
2020-000983-41, ID-076A301 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT04957719 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
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