The Effect of Morphine on Prasugrel Absorption in STEMI Patients

NCT01536964 | Completed Phase 4 DMC

• 2 other identifiers: STH162072011-003320-12
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• VerifyNow P2Y12 PRU measurement at 2 hours post dose

  Assessment of platelet function

  2 hours

Secondary Outcomes (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

Study Arms (2)

Morphine

EXPERIMENTAL

the effect of morphine on prasugrel absorption will be tested

Drug: morphine

Saline

PLACEBO COMPARATOR

Drug: saline

Interventions

morphine DRUG

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

Morphine

saline DRUG

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

Saline

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S5 7AU, United Kingdom

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Morphine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2012
• First Posted: February 22, 2012
• Study Start: April 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: June 14, 2022

Record last verified: 2022-06

Locations

GB (1)