Phase 3 study for people with Heart Disease

By invitation Phase 3

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status By invitation
Phase Phase 3
Sponsor Viatris Innovation GmbH
Registry number NCT04957719
Started 14 August 2021 Today 16 October 2026 Estimated completion 1 July 2027

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Royal Adelaide Hospital/ CNARTS Adelaide SA Status not stated
Grampians Health Ballarat VIC Status not stated
The Prince Charles Hospital Chermside QLD Status not stated
Monash Health Clayton VIC Status not stated
Concord Repatriation General Hospital (CRGH) (Concord Hospital) Concord NSW Status not stated
The Cardiologists Pty. Ltd Epping VIC Status not stated
The Canberra Hospital Garran ACT Status not stated
Gosford Hospital Gosford NSW Status not stated
Tasmanian Health at Royal Hobart Hospital Hobart TAS Status not stated
The Alfred Hospital Melbourne VIC Status not stated
The Royal Melbourne Hospitals Melbourne VIC Status not stated
Western Health - Sunshine Hospital St Albans VIC Status not stated
Wollongong Hospital - Illawarra Shoalhaven Local Health District Wollongong NSW Status not stated
The Queen Elizabeth Hospital Woodville South SA Status not stated

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 25000

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

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, 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,

* Chronic kidney disease defined as estimated glomerular filtration rate less than 60 mL/min/1.73 m2 and either known history of chronic kidney disease 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.

* 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.

Dates on the record

Started 14 August 2021
Estimated completion 1 July 2027
Registry last updated 23 July 2026
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 23 July 2026.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.