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OpenTrials
Completed

NCT Number: NCT01536964

The Effect of Morphine on Prasugrel Absorption in STEMI Patients

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.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S5 7AU, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Morphine

Drug

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

Saline

Drug

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

Primary outcomes

  1. VerifyNow P2Y12 PRU measurement at 2 hours post dose

    Time frame: 2 hours

    Assessment of platelet function

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Other

Collaborators

  • National Institute for Health Research, United Kingdom

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 22, 2012
Registry last updated
Jun 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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