The Effect of Morphine on Prasugrel Absorption in STEMI Patients

NCT ID: NCT01536964

Last Updated: 2022-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-03-31

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.

Conditions

Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Morphine

the effect of morphine on prasugrel absorption will be tested

Group Type: EXPERIMENTAL

morphine

Intervention Type: DRUG

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

Saline

Group Type: PLACEBO_COMPARATOR

saline

Intervention Type: DRUG

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

Interventions

morphine

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

Intervention Type: DRUG

saline

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role: collaborator

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

2011-003320-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

STH16207

Identifier Type: -

Identifier Source: org_study_id