Complete occlusion of a major coronary artery branch causing ST elevation on electrocardiogram. Adjunctive pharmacological therapy (including prasugrel) is given at the time of PPCI. MedDRA version: 14.1 Level: LLT Classification code 10064345 Term: ST segment elevation myocardial infarction System Organ Class: 100000004849
Conditions
Interventions
Trade Name: Efient
Product Name: Efient
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: prasugrel hydrochloride
CAS Number: 150322-43-3
Concentration unit: mg milligram(s)
Concentration t
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Admission to hospital with a STEMI >12m prior to recruitment 2. The patient must have given written (personally signed and dated) informed consent before completing any study-related procedures (i.e. any assessment or evaluation that would not have formed part of their normal medical care). 3. The patient must be between 18 -75 years of age. 4. Female participants must be postmenopausal, defined as ‘when a woman has experienced twelve consecutive months of amenorrhea (lack of menstruation) without a period’. 5. Willing and able to provide informed consent 6. Previous prasugrel and morphine sulphate use with no adverse effect. This will be ascertained from the medical notes when screening for potential participants. 7. Body weight > 60kg Patients take Prasugrel for 1 year following their STEMI. As we require patients not to be on the drug when recruited, we have to wait for at least 1 year following their STEMI to recruit them. 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 4 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: 1. The patient has any other medical condition or abnormality (e.g. malignancy or complication) that in the opinion of the investigator would impact upon the safety or efficacy of the study treatment or any study assessments. 2. The patient is enrolled in another research project, unless it is a study administering questionnaires/interviews only. 3. Active respiratory disorder, resting oxygen saturation 75 years 8. Body weight less than 60 kg 9. Active liver disease 10. Haemoglobin 180micromol/L 12. Drug or alcohol (> 40 units/week) misuse 13. Psychiatric or neurological illness that could interfere with compliance with the study protocol or impair understanding of the study 14. Insufficient forearm veins for intravenous cannula insertion 15. Female participants must not be pregnant or trying to conceive.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effects of morphine on the absorption and onset of action of prasugrel in patients with a prior history of ST-elevation Myocardial Infarction (STEMI).;Secondary Objective: None.;Primary end point(s): VerifyNow P2Y12 PRU measurement at 2 hours post dose. ;Timepoint(s) of evaluation of this end point: NA | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: Estimated time to PRU less than 150; maximal LTA response to ADP 20 micromoles at 2 hours post dose; final LTA response to ADP 5 micromoles at 2 hours post dose. Paired t-test will be used to compare the primary endpoint in the morphine and control phases and significance attached to P value less than 0.05. If the primary endpoint is significantly different between the two groups then the secondary endpoints will be assessed in order until such time as a non-significant P value is reached, again with significance P < 0.05. ;Timepoint(s) of evaluation of this end point: The timepoints for secondary endpoints are listed above. | — |
Countries
United Kingdom
Contacts
Public ContactJen Boston
Sheffield Teaching Hospitals NHS Foundation Trust
Outcome results
None listed