A Study to assess whether the pain killer morphine affects the way an anti-clotting drug (Prasugrel) is absorbed by the body.

• Conditions: 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: 14.1Level: LLTClassification code 10064345Term: ST segment elevation myocardial infarctionSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-003320-12-GB
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-07
• Last Update Posted: 13 May 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 12

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

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 < 95% or decompensated congestive cardiac failure
4.Current use of anti-platelet or anti-coagulant drugs apart from aspirin 75 mg daily, or receipt of any dose of clopidogrel, prasugrel or ticagrelor in the last 2 weeks
5.Current use of opiate analgesia
6.Any condition that the investigator believes may place the patient at substantially increased risk of bleeding, such as active bleeding, iron deficiency anaemia, uncontrolled hypertension, history of stroke, transient ischaemic attack or intracranial bleeding, or active cancer (other than localised skin cancer).
7.Age > 75 years
8.Body weight less than 60 kg
9.Active liver disease
10.Haemoglobin < 10 g/dl or platelet count < 100 x 109/dl
11.Serum Creatinine >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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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. <br>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.<br>;Timepoint(s) of evaluation of this end point: The timepoints for secondary endpoints are listed above.