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The Effect of Morphine on Prasugrel Absorption in STEMI Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01536964
First received: February 16, 2012
Last updated: April 2, 2013
Last verified: February 2013

February 16, 2012
April 2, 2013
April 2012
March 2013   (final data collection date for primary outcome measure)
VerifyNow P2Y12 PRU measurement at 2 hours post dose [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
Assessment of platelet function
VerifyNow P2Y12 PRU measurement at 1 hour post dose. [ Time Frame: 1hour ] [ Designated as safety issue: No ]
platelet function post prasugrel and morphine administration will be assessed
Complete list of historical versions of study NCT01536964 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
further assessment of platelet function
Estimated time to PRU less than 150; maximal LTA response to ADP 20 microM at 1 hour post dose; final LTA response to ADP 5 microM at 1 hour post dose. [ Time Frame: samples over 1h period ] [ Designated as safety issue: No ]
further assessment of platelet function
Not Provided
Not Provided
 
The Effect of Morphine on Prasugrel Absorption in STEMI Patients
Not Provided

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Cardiovascular Disease
  • Drug: morphine
    2.5mg of morphine will be given post Prasugrel administration with a further 2.5mg 5 minutes later
  • Drug: saline
    2.5ml of saline will be given post Prasugrel followed by a further 2.5ml as a comparator for the morphine
  • Experimental: Morphine
    the effect of morphine on prasugrel absorption will be tested
    Intervention: Drug: morphine
  • Placebo Comparator: Saline
    Intervention: Drug: saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01536964
STH16207, 2011-003320-12
Yes
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield Teaching Hospitals NHS Foundation Trust
Not Provided
Not Provided
Sheffield Teaching Hospitals NHS Foundation Trust
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP