ST elevation myocardial infarction.
Conditions
Interventions
Trade Name: Clexane
Product Name: Clexane
Pharmaceutical Form: Solution for infusion
Sponsors
Dr
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 2. Confirmation of the diagnosis of STEMI by the clinical team on the basis of history, ECG changes and angiographic findings 3. Pre-treatment with either ticagrelor or prasugrel 4. Intention to proceed with PPCI 5. 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 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Active bleeding that cannot be controlled by local measures 2. Female patients of child bearing age who have not had a sterilisation procedure 3. Patients with end stage renal failure requiring renal replacement therapy 4. Known thrombocytopenia (Platelet count < 100,000/µL) 5. Known history of intracranial haemorrhage 6. Known current treatment with oral anticoagulants 7. Known history of major surgery or trauma or history of GI/GU haemorrhage within the last month 8. Known intracranial malignancy or aneurysm 9. Known allergy to enoxaparin 10. Inability to easily understand verbal information given in English for any reason 11. Inability to give informed consent due to either temporary or permanent mental incapacity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary outcome measure of the study is the level of anti factor Xa activity ;Main Objective: The principal research objective is to assess the levels of anti clotting factor (Xa) activity. This is a direct measure of the effects enoxaparin which targets clotting factor (Xa). We would like to ensure that the proposed regimen will provide sufficient anti factor Xa activity at levels enough to reduce the risk of further acute heart attacks without greatly increasing the risk of bleeding. ; Secondary Objective: 1) As the small cells called platelets are central to clotting, we aim to assess the level of platelet activity. The level of platelet activity should be limited in response to tablet treatment (ticagrelor/prasugrel). This is to ensure that the suggested duration of enoxaparin infusion is sufficient. 2) The other major element of the clot is a protein called fibrin. We will assess the effects of the proposed regimen on the fibrin clot in blood. 3) We will collect pilot data on bleeding events and recurrence of heart attacks whilst receiving the proposed regimen. ; Timepoint(s) of evaluation of this end point: Blood samples for anti Xa activity, VerifyNow P2Y12 assay and fibrin clot dynamics will be collected at the following time points: 1. Time point 1 (T1) prior to anticoagulation – at the start of PCI procedure. 2. Time point 2 (T2) at the end of PPCI. 3. Time point 3 (T3) 2-3 hours from the start of enoxaparin infusion. 4. Time point 4 (T4) at the end of enoxaparin infusion. In patients with impaired kidney function (eGFR < 30 ml/min), T3 will be the last blood sample taken (at the end of the infusion). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Assess the level of P2Y12 inhibition in response to oral therapy. This will be achieved by performing the established P2Y12 assay. Although the delay in platelet inhibition is well established now, measuring P2Y12 inhibition is valuable in this case to ensure that adequate inhibition is achieved by the end of enoxaparin infusion. It would also provide useful information in case of complications such as stent thrombosis or bleeding. 2. Assess the effects of the proposed regimen on fibrin clot formation. This will be done by thromboelastography (TEG) in whole blood and by turbidimetric assay in plasma. 3. Obtain pilot data on the safety of the enoxaparin regimen by assessing bleeding rates within 12 hours following PCI. 4. Assess the efficacy of the proposed regimen by estimating the risk of stent thrombosis within 12 hours following PCI. | — |
Countries
United Kingdom
Contacts
Public ContactNana Theodorou
STH NHS FT
Outcome results
None listed