ST-elevation myocardial infarction Circulatory System
Conditions
Interventions
The LIBERATE trial is a double-blind trial for participants who have had an ST-elevation Myocardial Infarction (STEMI).
Participants will be randomised using an online bespoke database on a 1:1 basi
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent (including emergency consent) 2. Age = 18 years 3. Confirmation of the diagnosis of ST-elevation myocardial infarction by the clinical team on the basis of history and ECG findings 4. Intention to proceed with primary percutaneous coronary intervention (PCI) 5. Presentation within 6 hours of chest pain
Exclusion criteria
Exclusion criteria: 1. Inability to provide consent 2. All women of childbearing potential (WOCBP) are excluded from study entry. Women are only classed as non-WOCBP if they meet 1 or more of the following criteria: 2.1. Premenopausal female with documented hysterectomy 2.2. Premenopausal female with documented bilateral salpingectomy or oophorectomy 2.3. Postmenopausal female defined as no menses for 12 months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using contraception or hormonal replacement therapy (HRT). However, in the absence of 12 months of amenorrhoea, a single FSH measurement is insufficient. 3. Active bleeding 4. Known thrombocytopenia (with platelet count < 100,000/µl in last 12 months) 5. Known renal impairment (with estimated Glomerular Filtration Rate (eGFR) < 30ml/minute in last 12 months) 6. Left bundle branch block on ECG 7. Suspected non-thrombotic cause (e.g. spontaneous coronary artery dissection, vasospasm, Takotsubo cardiomyopathy) 8. Current treatment with oral anticoagulants 9. Cardiogenic shock – indicated by systolic blood pressure less than 80 mmHg or use of inotropes 10. Out of hospital cardiac arrest 11. Known history of MI or prior coronary artery bypass graft (CAGB) surgery 12. Known history of pre-existing cardiomyopathy 13. Known history of any type of intracranial haemorrhage 14. Known history of platelet function or coagulation disorder 15. Known history of any spontaneous major bleeding (indicated by bleeding requiring transfusion) 16. Known intracranial malignancy (any type) or intracranial aneurysm (any type) 17. Known history of major surgery defined as surgery involving opening a major body cavity (such as the abdomen, chest, or skull) or well-vascularised tissues (such as the colon mucosa and prostate tissue) or opening a major artery, within the last month 18. Known history of any type of surgery within the last week 19. Known history of major trauma (defined as serious injury with the potential to result in disability or death) within the last month 20. Contraindication to cardiac MRI (pacemaker, allergy to gadolinium contrast, non-MRI compatible implants or foreign bodies) 21. Known hypersensitivity to investigational medicinal product (glenzocimab) 22. Use of an investigational drug within 30 days prior to screening or 5 half-lives or twice the duration of biological effect of the investigational product (whichever is longer) 23. Known use of GPIIb/IIa inhibitor within the last 2 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Myocardial infarct size as a percentage of left ventricular (LV) mass measured using delayed gadolinium-enhanced cardiovascular magnetic resonance (CMR) imaging at 90 days (± 21 days) post-myocardial infarction | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Resolution of ST-elevation measured using serial 12-lead ECGs at days 1, 2 and 3 (if still an inpatient) 2. Restoration of Thrombolysis in Myocardial Infarction (TIMI) 3 flow and myocardial blush grade measured using coronary angiography at the time of the therapeutic procedure 3. Collagen-induced platelet aggregation measured using Multiple Electrode Aggregometry on day 1 4. Area under the curve of serum troponin and CK-MB levels measured in the hospital laboratory over the 48 hours post-myocardial infarction 5. Inflammation assessed through serial high-sensitivity C-reactive protein (CRP) levels measured in serum using a CRP test at days 1, 2, 3 (if still an inpatient) and 30 6. Safety profile of glenzocimab: deaths, SAEs, SUSARs, bleeding-related events and treatment-emergent adverse events measured using study records throughout the trial until day 90 | — |
Countries
England, United Kingdom
Contacts
Public ContactLiberate Trials Team
Outcome results
None listed