ST-segment elevation myocardial infarction Non ST-segment elevation myocardial infarction MedDRA version: 17.1 Level: PT Classification code 10053460 Term: Antiplatelet therapy System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 17.1 Level: LLT Classification code 10064347 Term: Non ST segment elevation myocardial infarction System Organ Class: 100000004849 MedDRA version: 17.1 Level: LLT Classification code 10064345 Term: ST segment elevation myocardial infarction
Conditions
Interventions
Trade Name: Efient
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Prasugrel Hydrochloride
CAS Number: 150322-43-3
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: ra
Sponsors
The Royal Wolverhampton NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients presenting with STEMI for PCI (characterized by chest discomfort, and prominent ST-segment elevation) 2)Patients presenting with NSTEMI (characterized by chest discomfort, raised levels of myocardial enzymes and/or ST-segment depression or prominent T wave inversion) 3)Able to give verbal consent (STEMI patients pre procedure) and/or written consent (STEMI after procedure and NSTEMI patients prior to enrolment). 4)Age>18 years of age 5)Able to take Aspirin and either prasugrel or ticagrelor. 6)Have no concurrent septic or inflammatory illness 7)Thienopyridine naive 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 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1)Be unable to provide verbal and written consent 2)Allergic to aspirin or any of the P2Y12 antagonists in the trial 3)Have pre-existing cardiogenic shock 4)Have a concurrent septic or inflammatory disease e.g. rheumatoid arthritis, lupus, pneumonia. 5)Already taking a P2Y12 inhibitor 6)Known bleeding diathesis 7)Patients under 75 years of age or under 60 kg or those who have had a previous stroke/transient ischaemic attack, will not be eligible for prasugrel but rather ticagrelor. 8)Patients with a history of intracranial haemorrhage will not receive prasugrel or ticagrelor but rather will receive treatment with clopidogrel.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the degree and time-course of platelet inhibition of both prasugrel and ticagrelor when given acutely before emergency primary angioplasty for STEMI, during the procedure and in the following 4 hours. ;Secondary Objective: To determine if acute STEMI per se leads to reduced antiplatelet activity ( with prasugrel or ticagrelor) when compared to a more stable cohort of patients presenting with NSTEMI/UA who are treated with the same agents. ;Primary end point(s): 1) The degree of platelet inhibition generated by prasugrel vs ticagrelor from the time of loading dose administration and during the following 4 hours of therapy in pateints with STEMI and NSTEMI 2) To assess whether there is a difference in antiplatelet activity of Ticagrelor and Prasugrel in patients with STEMI vs NSTEMI.;Timepoint(s) of evaluation of this end point: We are propsosing to collect blood samples for analysis at 20 mins, first balloon inflation (STEMI patients only), 60 mins, and 4 hours after loading with a P2Y12 receptor antagonist. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To determine the concentration of prasugrel and ticagrelor active metabolite in plasma from the time of administration and during the following 4 hours. This will be measured using liquid chromatography with tandem mass spectrometry.;Timepoint(s) of evaluation of this end point: We are propsosing to collect blood samples for analysis at 20 mins, 60 mins, and 4 hours after loading with a P2Y12 receptor antagonist. | — |
Countries
United Kingdom
Contacts
Public ContactLorraine Jacques
The Royal Wolverhampton NHS Trust
Outcome results
None listed