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The Effect of Morphine on Prasugrel Absorption in STEMI Patients

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01536964
Enrollment
12
Registered
2012-02-22
Start date
2012-04-30
Completion date
2013-03-31
Last updated
2022-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease

Brief summary

Heart Attacks are a major cause of death in this country. When patients have a heart attack, they are treated with anti-clotting drugs, one of which is a drug called Prasugrel. It is important that Prasugrel starts to work as quickly as possible following a heart attack. As many patients who have a heart attack experience excruciating pain, they are often given morphine (a strong painkiller) by the Ambulance crew. We think that morphine may affect how Prasugrel is absorbed from the stomach and may delay how quickly it starts to work. We intend to study the effect of morphine on the absorption of Prasugrel.

Interventions

DRUGmorphine

2.5mg of morphine will be given post Prasugrel administration with a further 2.5mg 5 minutes later

DRUGsaline

2.5ml of saline will be given post Prasugrel followed by a further 2.5ml as a comparator for the morphine

Sponsors

National Institute for Health Research, United Kingdom
CollaboratorOTHER_GOV
Sheffield Teaching Hospitals NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* \>18 years of age and willing and able to provide informed consent * Admission to hospital with a STEMI \>12 months prior to recruitment * Previous prasugrel and morphine use with no adverse effect

Exclusion criteria

* Active respiratory disorder, resting oxygen saturation \< 95% or decompensated congestive cardiac failure * 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 * Current use of opiate analgesia

Design outcomes

Primary

MeasureTime frameDescription
VerifyNow P2Y12 PRU measurement at 2 hours post dose2 hoursAssessment of platelet function

Secondary

MeasureTime frameDescription
Estimated time to PRU less than 150; maximal LTA response to ADP 20 microM at 2 hours post dose; final LTA response to ADP 5 microM at 2 hours post dose.2 hoursfurther assessment of platelet function

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026