The Effect of Morphine on Prasugrel Absorption in STEMI Patients

Cardiovascular Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01536964
• Other study ID #: STH16207
• Secondary ID: 2011-003320-12
• Status: Completed
• Phase: Phase 4
• Start date: April 2012
• Est. completion date: March 2013

Study information

• Verified date: June 2022
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Drug:
• morphine
2.5mg of morphine will be given post Prasugrel administration with a further 2.5mg 5 minutes later
• saline
2.5ml of saline will be given post Prasugrel followed by a further 2.5ml as a comparator for the morphine

Locations

Country	Name	City	State
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield	South Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust	National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VerifyNow P2Y12 PRU measurement at 2 hours post dose	Assessment of platelet function	2 hours
Secondary	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.	further assessment of platelet function	2 hours