E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
ST-elevation myocardial infarction |
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E.1.1.1 | Medical condition in easily understood language |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10000891 |
E.1.2 | Term | Acute myocardial infarction |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
This is a feasibility study with the objective to establish the practically possible recruitment rate into the study. The other primary objective is to collect more pilot data on bleeding events within the first 24 hours and compare those between the two treatment arms.
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E.2.2 | Secondary objectives of the trial |
• Collect pilot data on efficacy; acute stent thrombosis happening within 24 hours. • Collect pilot data on the composite outcome of recurrent myocardial infarction, ischaemic stroke or CV death at 1-month. • Collect data on vital status (mortality) at 1 year. • ST-segment resolution post PPCI. This is an established surrogate marker for microvascular obstruction and long-term outcomes
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
There will be one pharmacodynamic substudy. 30 patients will be included in the substudy to detect the difference in pharmacodynamic effects between the two treatment groups. |
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E.3 | Principal inclusion criteria |
• Age ≥ 18 • Confirmation of the diagnosis of STEMI by the clinical team on the basis of history and ECG changes • Intention to proceed with PPCI • Treated with opiates for analgesia • Feasibility to obtain informed verbal consent pre PPCI
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E.4 | Principal exclusion criteria |
1. Active bleeding that cannot be controlled by local measures 2. Pregnant patients 3. Patients with end-stage renal failure requiring renal replacement therapy 4. Patients with cardiogenic shock 5. Known thrombocytopenia (Platelet count < 100,000/μL) 6. Known history of intracranial haemorrhage 7. Known current treatment with oral anticoagulants 8. Known history of major surgery or trauma or history of GI/GU haemorrhage within the last month 9. Known intracranial malignancy or aneurysm 10. Known allergy to enoxaparin 11. Known hypersensitivity to benzylalcohol 12. Patients with known acute bacterial endocarditis 13. Known active gastric or duodenal ulceration 14. Inability to easily understand verbal information given in English for any reason 15. Inability to give informed consent due to either temporary or permanent mental incapacity 16. Current participation, or participation within the last month, in an interventional clinical trial.
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E.5 End points |
E.5.1 | Primary end point(s) |
1) Determine recruitment rate over the study period 2) Bleeding rates.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Recruitment rate will be determined at the end of recruitment Bleeding rates will be determined at 24 hours post PPCI |
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E.5.2 | Secondary end point(s) |
1. Acute stent thrombosis rate in each treatment arm (within 24 hours). These rates will be compared between the two treatment groups. 2. Rates of ST-segment resolution in each treatment arm. Comparison will be undertaken between presentation ECG and ECG performed 1 hour post PPCI. We will compare rates of ST segment resolution between the two treatment groups. 3. Rates of the composite outcome of recurrent myocardial infarction, ischaemic stroke or cardiovascular death within 30 days of STEMI. These rates will be compared between the two treatment groups. 4. 1-year mortality rates. These will be compared between the two groups.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Determine feasibility of conducting a bigger study and to collect pilot data on bleeding events |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The study will be declared as ended following LVLS for the data collection and after the data has been verified. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 1 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 1 |