BridgeMD
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
EU CTIS ID: 2023-505438-85-00
What this study is testing
The primary objective of the study is to assess the clinical efficacy of selatogrel when self-administered upon occurrence of symptoms suggestive of an acute myocardial infarction (AMI) in subjects at risk of having a recurrent AMI.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed and dated informed consent prior to any study-mandated procedure.
- Male or female subject ≥ 18 years old at the time of signing the informed consent form.
- 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.
- Diagnosis of multivessel coronary artery disease defined as ≥ 50% stenosis on 2 or more coronary artery territories, during a prior cardiac catheterization or cardiac catheterization during thequalifying 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.
- Successfully self-administered placebo according to the autoinjector Instructions for use during screening.
You likely can't join if
- 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.
- Chronic anemia with hemoglobin 10 g/dL.
- Chronic thrombocytopenia with platelet count 100,000/mm3.
- Concomitant diseases or conditions that, in the opinion of the investigator, are not compatible with study participation.
- 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.
See the full eligibility criteria
- Signed and dated informed consent prior to any study-mandated procedure.
- Male or female subject ≥ 18 years old at the time of signing the informed consent form.
- 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.
- Diagnosis of multivessel coronary artery disease defined as ≥ 50% stenosis on 2 or more coronary artery territories, during a prior cardiac catheterization or cardiac catheterization during thequalifying 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.
- Successfully self-administered placebo according to the autoinjector Instructions for use during screening.
- 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.
- Chronic anemia with hemoglobin 10 g/dL.
- Chronic thrombocytopenia with platelet count 100,000/mm3.
- Concomitant diseases or conditions that, in the opinion of the investigator, are not compatible with study participation.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- Malaysia
- Brazil
- Thailand
- Turkey
- Korea, Republic of
- Chile
- New Zealand
- Philippines
- Taiwan
- Peru
- Saudi Arabia
- Canada
- Israel
- Switzerland
- United Kingdom
- United Arab Emirates
- China
- United States
- Australia
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; Malaysia; Brazil; Thailand; Turkey; Korea, Republic of and 18 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.