Patients with ST segment elevation myocardial infarction MedDRA version: 21.1 Level: PT Classification code 10053460 Term: Antiplatelet therapy System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.0 Level: PT Classification code 10000891 Term: Acute myocardial infarction System Organ Class: 10007541 - Cardi
Conditions
Interventions
Trade Name: Ticagrelor
Product Name: Ticagrelor
Product Code: N/A
Pharmaceutical Form: Tablet
INN or Proposed INN: Ticagrelor
Sponsors
Royal Papworth Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion in the study subjects should fulfill the following criteria: 1. Provision of informed verbal consent prior to any study specific procedures taking place with written consent confirmed prior to in-patient cardiac MRI. 2. Male or female adult patient aged 18 – 90 years old 3. Any STEMI (ST elevation = 2mm in contiguous chest leads) with chest pain symptom onset =65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: Subjects should not enter the study if any of the following exclusion criteria are fulfilled: 1. Cardiogenic shock 2. Previous myocardial infarction in the infarct-related artery requiring intervention 3. Unfavourable coronary anatomy for PCI: left main/surgical or distal coronary disease 4. Already prescribed Ticagrelor at the time of admission 5. Factors affecting study drug administration/ absorption: vomiting or allergy to the IMP 6. Concomitant use of potent CYP3A4 inhibitors/ inducers (e.g ketoconazole and rifampicin) or CYP3A4 substrates with a narrow therapeutic window (e.g. cisapride and ergot alkaloids) or simvastatin / lovostatin >40mg oral dose. 7. Severe bleeding diathesis or current active bleeding 8. History of intracranial haemorrhage 9. Known Moderate or Severe hepatic impairment or abnormal liver function tests (ALT >5x ULN) at baseline (if available) 10. Severe asthma that has required hospital admission or significant bradycardia/ complete heart block diagnosed on ECG (contraindications to adenosine). 11. Severe co-morbidity with a life expectancy < 3 months. 12. Women of child bearing age unless confirmed by direct questioning that they are reproductively sterile or post-menopausal. 13. Concomitant treatment with anticoagulants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principle research question of this study is concerned with how the cardioprotective effect observed with Ticagrelor happens. Routine clinical practice is to give patients suffering from an acute heart attack antiplatelet therapy that has the effect of thinning the blood and reducing blood clot formation, improving the mircovascular circulation to the heart muscle and limiting cardiac muscle death during STEMI. However, the antiplatelet effect of Ticargelor is not immediate and the benefit observed with this drug is, therefore, hypothesized to be mediated via an alternative process. The principal research question of this study is to explore whether the early benefit of Ticagrelor, in addition to it’s established antiplatelet action, is co-mediated by adenosine in maintaining and/or improving myocardial microcirculatory function. ; Secondary Objective: The secondary objectives of the study are concerned with restoration of coronary blood flow resulting from PPCI (primary percutaneous coronary intervention) afforded between the two patient groups: one of which will receive clopidogrel, and the other which will recieve Ticagrelor. Measurements are as follows: 1. TIMI flow and TMBG pre/post PPCI 2. ST segment resolution at 60 minutes 3. OCT (optical coherence tomography) quantified clot volume pre/post PPCI (where feasible, safe and clinically possible) 4. Cardiac troponin-I at 0, 12 and 24 hours (+/- 2 hours for 12 and 24hr samples) 5. Cardiac MRI microvascular obstruction at 24-72hrs (where logistically feasible during the in-patient stay) and infarct size at 3 calendar months (+/- 14 days). 6. Myocardial Salvage and Salvage Index calculated on cardiac MRI 7. Trans-mural extent of Late Gadolinium Enhancement (LGE) on cardiac MRI 8. IMR calculated using Yo | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a TIMI flow and TMBG pre/post PPCI b ST segment resolution c OCT quantified clot volume pre/post PPCI (where feasible, safe and clinically possible) d Cardiac troponin – I at 0, 12 and 24 hours (+/- 2 hours for 12 and 24hr samples) e Cardiac MRI microvascular obstruction between 24-72 hours (where logistically feasible during the in-patient stay) and infarct size at 3 calendar months (+/- 14 days). f Myocardial Salvage and Salvage Index calculated on cardiac MRI g Trans-mural extent of Late Gadolinium Enhancement (LGE) on cardiac MRI h IMR calculated using Yong's formula ; Timepoint(s) of evaluation of this end point: a 1hr b 2hrs c 0-1hr d 0,12 and 24hrs e 24-72hrs and 3 months f 24-72hrs and 3 months g 24-72hrs and 3 months | — |
Countries
United Kingdom
Contacts
Public ContactMelissa Duckworth
Royal Papworth Hospital NHS Foundation Trust
Outcome results
None listed