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The Effect of Morphine on Prasugrel Absorption in STEMI Patients

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ClinicalTrials.gov Identifier: NCT01536964
Recruitment Status : Completed
First Posted : February 22, 2012
Last Update Posted : April 4, 2013
Sponsor:
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Drug: morphine Drug: saline Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Study Start Date : April 2012
Primary Completion Date : March 2013
Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01536964


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

Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01536964     History of Changes
Other Study ID Numbers: STH16207
2011-003320-12 ( EudraCT Number )
First Posted: February 22, 2012    Key Record Dates
Last Update Posted: April 4, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Cardiovascular Diseases
Morphine
Prasugrel Hydrochloride
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Platelet Aggregation Inhibitors