The Effect of Morphine on Prasugrel Absorption in STEMI Patients

Phase 4

Completed

• Conditions: Cardiovascular Disease
• Interventions: Drug: saline; Drug: morphine

• Registration Number: NCT01536964
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-16
• Study First Submitted QC: 2012-02-21
• Study First Posted: 2012-02-22
• Study Start: 2012-04
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-10
• Last Update Posted: 2022-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Saline	saline	-
Morphine	morphine	the effect of morphine on prasugrel absorption will be tested

Primary Outcome Measures

Name	Time	Method
VerifyNow P2Y12 PRU measurement at 2 hours post dose	2 hours	Assessment of platelet function

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sheffield Teaching Hospitals NHS Foundation Trust; 🇬🇧 Sheffield, South Yorkshire, United Kingdom