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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05367336
Other study ID # EGME#04-2021
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date August 31, 2022
Est. completion date May 2024

Study information

Verified date October 2023
Source Spectrum Health - Lakeland
Contact Monique Luna
Phone 2699858679
Email monique.allen@spectrumhealth.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal is to determine whether fentanyl and morphine have similar effects in reducing aspirin's effect upon platelets in emergency department patients with chest discomfort. Morphine has been shown to worsen outcomes in heart attack patients due to reduction of oral anti-platelet agent effectiveness and so many providers have switches to using fentanyl. However, it is largely unknown whether fentanyl has similar effects.


Description:

Patients presenting to the emergency department with chest discomfort who are being administered aspirin will be offered enrollment in this study. At the time of their zero and two hour troponin we will also draw platelet aggregration studies to determine the effects of aspirin upon platelets. Narcotic medicines slow the absorption of aspirin. Morphine has therefore been shown to decrease the effectiveness of aspirin. Many providers therefore use fentanyl instead, however little is known about the effects of fentanyl upon aspirin. We will therefore compare the platelet reactivity of patients receiving morphine, fentanyl, or no narcotics


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Adult Emergency Department patients undergoing 0 and 2 hour troponin testing - administered aspirin within 30 minutes of the initial blood draw. - patient presented via private vehicle - provide informed consent Exclusion Criteria: - Patients not expected to get a 2 hour troponin; - patients already on aspirin, clopidogrel, or stronger anti-coagulants; - patients who arrived via EMS (Emergency Medical Services) given it can be difficult to find the run reports to determine whether patient received fentanyl in the pre-hospital period; - pregnant patients; - patients on chronic narcotics; - patients already once enrolled in this study, - inability to provide consent in English

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Morphine
second group will be receiving morphine
Fentanyl
third group receiving fentanyl

Locations

Country Name City State
United States Spectrum Health Lakeland Saint Joseph Michigan

Sponsors (1)

Lead Sponsor Collaborator
Spectrum Health - Lakeland

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary platelet aggregation arachidonic acid platelet aggregation activity 2 hours
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