The Effect of Morphine on Prasugrel Absorption in STEMI Patients

• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust (Other)
• Overall Status: Completed
• CT.gov ID: NCT01536964
• Collaborator: National Institute for Health Research, United Kingdom (Other)
• Enrollment: 12
• Location: 1
• Arms: 2
• Duration (Months): 11
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. VerifyNow P2Y12 PRU measurement at 2 hours post dose [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. [2 hours]

   further assessment of platelet function

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield	South Yorkshire	United Kingdom	S5 7AU

Sponsors and Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust
• National Institute for Health Research, United Kingdom

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT01536964
• Other Study ID Numbers: STH16207; 2011-003320-12
• First Posted: Feb 22, 2012
• Last Update Posted: Jun 14, 2022
• Last Verified: Jun 1, 2022

• Additional relevant MeSH terms: Cardiovascular Diseases; Morphine

Study Results

No Results Posted as of Jun 14, 2022