ST-elevation myocardial infarction MedDRA version: 20.0 Level: PT Classification code 10000891 Term: Acute myocardial infarction System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: Clexane
Product Name: Clexane
Pharmaceutical Form: Solution for infusion
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: • 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 ;Primary end point(s): 1) Determine recruitment rate over the study period 2) Bleeding rates. ;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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. ;Timepoint(s) of evaluation of this end point: As above. | — |
Countries
United Kingdom
Contacts
Public ContactNana Theodorou
Sheffield Teaching Hospitals NHS Foundation Trust
Outcome results
None listed