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The Effect of Morphine on Prasugrel Absorption in STEMI Patients

This study has been completed.
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust Identifier:
First received: February 16, 2012
Last updated: April 2, 2013
Last verified: February 2013
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.

Condition Intervention Phase
Cardiovascular Disease Drug: morphine Drug: saline Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)

Resource links provided by NLM:

Further study details as provided by Sheffield Teaching Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • VerifyNow P2Y12 PRU measurement at 2 hours post dose [ Time Frame: 2 hours ]
    Assessment of platelet function

Secondary Outcome Measures:
  • 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. [ Time Frame: 2 hours ]
    further assessment of platelet function

Enrollment: 12
Study Start Date: April 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Morphine
the effect of morphine on prasugrel absorption will be tested
Drug: morphine
2.5mg of morphine will be given post Prasugrel administration with a further 2.5mg 5 minutes later
Placebo Comparator: Saline Drug: saline
2.5ml of saline will be given post Prasugrel followed by a further 2.5ml as a comparator for the morphine


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
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Please refer to this study by its identifier: NCT01536964

United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, United Kingdom, S5 7AU
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
  More Information

Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust Identifier: NCT01536964     History of Changes
Other Study ID Numbers: STH16207
2011-003320-12 ( EudraCT Number )
Study First Received: February 16, 2012
Last Updated: April 2, 2013

Additional relevant MeSH terms:
Cardiovascular Diseases
Prasugrel Hydrochloride
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Platelet Aggregation Inhibitors processed this record on September 18, 2017