Platelet Reactivity With Fentanyl, Morphine, or no Narcotic

NCT05367336 | Terminated Phase 2 Results

• 1 other identifier: EGME#04-2021
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fentanyl; Platelet Reactivity

Outcome Measures

Primary Outcomes (2)

• Baseline Arachidonic Acid Maximum Aggregation (%) Result

  Arachidonic Acid Maximum Aggregation is assessed using light transmission aggregometry (LTA). This method involves adding arachidonic acid to platelet-rich plasma (PRP) and measuring the change in light transmittance as platelets aggregate. The maximum aggregation percentage is recorded as the highest point of aggregation observed during the test. From a clinical perspective, normal aggregation is considered 70% or higher and values below 70% may indicate platelet dysfunction or the influence of antiplatelet medications such as aspirin. In this study, the control group is expected to show a significant decrease in Arachidonic Acid Maximum Aggregation (%) from the baseline to the 2-hour mark. However, this decrease is anticipated to be smaller in the groups receiving morphine and fentanyl.

  Baseline

• 2 Hour Arachidonic Acid Maximum Aggregation (%) Result

  Arachidonic Acid Maximum Aggregation is assessed using light transmission aggregometry (LTA). This method involves adding arachidonic acid to platelet-rich plasma (PRP) and measuring the change in light transmittance as platelets aggregate. The maximum aggregation percentage is recorded as the highest point of aggregation observed during the test. From a clinical perspective, normal aggregation is considered 70% or higher and values below 70% may indicate platelet dysfunction or the influence of antiplatelet medications such as aspirin. In this study, the control group is expected to show a significant decrease in Arachidonic Acid Maximum Aggregation (%) from the baseline to the 2-hour mark. However, this decrease is anticipated to be smaller in the groups receiving morphine and fentanyl.

  2 hours

Study Arms (3)

Control

NO INTERVENTION

not receiving any narcotics

Morphine

EXPERIMENTAL

the second group will be those receiving morphine

Drug: Morphine

Fentanyl

EXPERIMENTAL

the 3rd group will be those receiving fentanyl

Drug: Fentanyl

Interventions

Morphine DRUG

second group will be receiving morphine

Morphine

Fentanyl DRUG

third group receiving fentanyl

Fentanyl

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• over the age of 18

You may not qualify if:

• 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

Sponsors & Collaborators

• Corewell Health South: lead

Study Sites (1)

Spectrum Health Lakeland

Saint Joseph, Michigan, 49085, United States

Location

MeSH Terms

Interventions

Morphine; Fentanyl

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; Piperidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Rachelle Pichot; Clinical Research Specialist
• Organization: Corewell Health Lakeland

rachelle.pichot@corewellhealth.org

240-389-7340

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: May 10, 2022
• Study Start: August 31, 2022
• Primary Completion: February 18, 2025
• Study Completion: February 18, 2025
• Last Updated: May 21, 2025
• Results First Posted: April 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)