CompletedPhase 2

A Medical Research Study to Evaluate the Effects of ACT-246475 in Adults With Heart Attack

Belgium, Israel, Switzerland48 participantsStarted 2018-07-10

Plain-language summary

The goal of this study is to find out how fast a drug called selatogrel (ACT-246475) can prevent platelets from binding together. This study will also help to find out more about the safety of this new drug. The drug selatogrel (ACT-246475) will be used in 2 different doses (8 mg or 16 mg) and will be administered in the thigh.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Main Inclusion Criteria: * Informed consent obtained prior to any study-mandated procedure, * Males aged from 18 to 85 and postmenopausal females aged up to 85 years, * Onset of symptoms of AMI of more than 30 min and less than 6 hours prior to randomization, * Subjects presenting a type I AMI including STEMI or NSTEMI. Main Exclusion Criteria: * Cardiogenic shock or severe hemodynamic instability, * Cardiopulmonary resuscitation, * Loading dose of any oral P2Y12 receptor antagonist prior to randomization, * Planned fibrinolytic therapy or any fibrinolytic therapy administered within 24 h prior to randomization, * Known platelet disorders (e.g., thromboasthenia, thrombocytopenia, von Willebrand disease). * Active internal bleeding, or bleeding diathesis or conditions associated with high risk of bleeding. * Known clinically important anemia. * Oral anticoagulation therapy within 7 days prior to randomization

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With a Pharmacodynamic Response as Assessed by the Inhibition of Platelet Aggregation

Timeframe: 30 minutes after the administration of the subcutaneous injection

Trial details

NCT IDNCT03487445

SponsorViatris Innovation GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-11-10

Results submitted2021-07-30

View on ClinicalTrials.gov More Acute Myocardial Infarction trials