We Partner 4 Research

Conditions

• Cardiovascular Risk
• Acute Myocardial Infarction (AMI)

Eligibility

Eligible Ages

Over 18 Years

Eligible Genders

All

Accepts Healthy Volunteers

No

Criteria

Key inclusion:

- Age 18 years or above at the time of signing the informed consent.

- Hospitalisation for acute myocardial infarction with evidence of type 1 myocardial
infarction (MI) by invasive angiography performed at site with percutaneous coronary
intervention (PCI) capabilities.

- ST-segment elevation myocardial infarction (STEMI) with all the following: a)
Relevant onset of symptoms suggestive of cardiac ischaemia within 12 hours before
hospitalisation.

b) Electrocardiogram (ECG)-changes (in the absence of left ventricular hypertrophy
or left bundle branch block): ST-segment elevation at the J point in at least two
contiguous leads greater than or equal 0.25 (millivolt) mV in men less than 40
years, greater than or equal 0.2 mV in men greater than or equal 40 years, or
greater than or equal 0.15 mV in women in leads V2-V3; and/or greater than or equal
0.1 mV in all other leads.

OR

- Non-ST-segment myocardial infarction with all the following: a)Relevant onset of
symptoms suggestive of cardiac ischaemia within 24 hours before hospitalisation. b)
Rise and/or fall in cardiac troponin I or T with at least one value above the 99th
percentile upper reference limit.

- Possibility for both randomisation and administration of the loading dose of study
intervention as early as possible after invasive procedure, and latest within 36
hours of hospitalisation(time 0) for STEMI, and latest within 48 hours of
hospitalisation (time 0) for NSTEMI.

- Presence of at least one of the following criteria confirmed based on the
participant's medical records and/or medical history interview: a) Any prior MI. b)
Prior coronary revascularisation. c) Diabetes mellitus treated with ongoing
glucose-lowering agent(s). d)Known chronic kidney disease (CKD) (estimated
glomerular filtration rate (eGFR) greater than equal 15 and less than 60 milliliter
per minute per 1.73 square meter (mL/min/1.73 m^2). e) Prior ischaemic stroke. f)
Known carotid disease or peripheral artery disease in the lower extremities. g)
Multivessel coronary artery diseaseh (current/prior). h) For STEMI patients only:
anterior MI at index acute myocardial infarction (AMI)

Key exclusion:

- Use of fibrinolytic therapy for treatment of the current AMI.

- Chronic heart failure classified as being in New York Heart Association (NYHA) Class
IV.

- Ongoing haemodynamic instability defined as any of the following: a) Killip Class
III or IV. b) Sustained and/or symptomatic hypotension (systolic blood pressure less
than 90 millimeters of mercury (mmHg)).

- Severe kidney impairment defined as any of the following: a) eGFR less than 15
mililitre per minute per 1.73 m^2. b) Chronic haemodialysis or peritoneal dialysis.

- Known alanine aminotransferase (ALT) greater than 8 x upper limit of normal
(reference range) (ULN).

- Severe hepatic disease defined as at least one of the following: a)Previously known
or current hepatic encephalopathy (clinical evaluation). b)Previously known or
current ascites (clinical evaluation). c) Jaundice (clinical evaluation). d)
Previous oesophageal/gastric variceal bleeding. c) Known hepatic cirrhosis.

- Major cardiac surgical (including but not restricted to coronary artery bypass graft
surgery (CABG)), non-cardiac surgical, or major endoscopic procedure (thoracoscopic
or laparoscopic) within the past 60 days or any major surgical procedure planned at
the time of randomisation or as treatment for the current AMI (CABG). Deferred
(staged)percutaneous coronary intervention for a non-culprit vessel identified
during the current AMI is allowed.

- Clinical evidence of, or suspicion of, active infection at the discretion of the
investigator.

- Known (acute or chronic) hepatitis B or hepatitis C.

- History or evidence of untreated latent tuberculosis (TB) such as (but not limited
to): a) History of a positive TB test or chest X-ray compatible with latent TB; and
TB treatment initiated less than 28 days prior to randomisation. b) Participants
with TB risk factors but unwilling to undergo TB treatment if confirmed positive for
latent TB based on central laboratory test at baseline (visit 2).

Recruiting Locations

Study Contact