Influence of Naloxone on Ticagrelor Pharmacokinetics and Pharmacodynamics in Patients With Unstable Angina Pectoris on Concomitant Treatment With Morphine

NCT02939248 | Completed Phase 4

• 1 other identifier: CMUMK202G
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate differences in the pharmacokinetics and pharmacodynamics of ticagrelor and its active metabolite between patients who received ticagrelor and morphine followed by naloxone versus patients treated with ticagrelor and morphine alone for unstable angina pectoris.

Conditions

Unstable Angina Pectoris

Outcome Measures

Primary Outcomes (1)

• Time to maximum concentration (tmax) for ticagrelor and AR-C124900XX for ticagrelor+morphine vs ticagrelor+morphine+naloxone arms

  6 hours

Secondary Outcomes (4)

• Maximum ticagrelor and AR-C124900XX concentration at 6h after administration

  6 hours

• Area under the plasma concentration-time curve for ticagrelor (AUC 0-6h)

  prior to the initial dose and 15 min, 30 min, 45 min, 1h, 2h, 3h, 4h, 6h post dose

• Area under the plasma concentration-time curve for AR-C124900XX (AUC 0-6h)

  prior to the initial dose and 15 min, 30 min, 45 min, 1h, 2h, 3h, 4h, 6h post dose

• Platelet arbitrary aggregation units/min assessed by Multiple Electrode Aggregometry

  prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h post dose

Study Arms (2)

Crushed ticagrelor followed by morphine

ACTIVE COMPARATOR

crushed ticagrelor 180 mg administered orally followed by morphine 5 mg intravenously

Drug: Crushed ticagrelor followed by morphine

Crushed ticagrelor, morphine,naloxone

ACTIVE COMPARATOR

crushed ticagrelor 180 mg administered orally followed by morphine 5 mg intravenously and naloxone 1 mg orally

Drug: Crushed ticagrelor, morphine,naloxone

Interventions

Crushed ticagrelor followed by morphine DRUG

Crushed ticagrelor (180 mg) followed by morphine 5 mg intravenously

Also known as: Brilique

Crushed ticagrelor followed by morphine

Crushed ticagrelor, morphine,naloxone DRUG

Crushed ticagrelor (180 mg) orally followed by morphine 5 mg intravenously and naloxone 1 mg orally

Also known as: Brilique

Crushed ticagrelor, morphine,naloxone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent prior to any study specific procedures
• Diagnosis of unstable angina
• Male or non-pregnant female, aged 18-80 years
• Provision of informed consent for angiography and PCI
• GRACE score \<140 pts

You may not qualify if:

• treatment with ticlopidine, clopidogrel, prasugrel or ticagrelor within 14 days before the study enrollment
• current treatment with morphine or any opioid "mi" receptor agonist
• hypersensitivity to ticagrelor
• current treatment with oral anticoagulant or chronic therapy with low-molecular-weight heparin
• active bleeding
• history of intracranial hemorrhage
• recent gastrointestinal bleeding (within 30 days)
• history of coagulation disorders
• platelet count less than \<100 x10\^3/mcl
• hemoglobin concentration less than 10.0 g/dl
• history of moderate or severe hepatic impairment
• history of major surgery or severe trauma (within 3 months)
• risk of bradycardic events as judged by the investigator
• second or third degree atrioventricular block during screening for eligibility
• history of asthma or severe chronic obstructive pulmonary disease

Sponsors & Collaborators

• Collegium Medicum w Bydgoszczy: lead

Study Sites (1)

Cardiology Department, Dr. A. Jurasz University Hospital

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-094, Poland

Location

MeSH Terms

Conditions

Angina, Unstable

Interventions

Ticagrelor; Morphine; Naloxone

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Jacek Kubica, MD., PhD.

  Cardiology Department, Dr. A. Jurasz University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Jacek Kubica, MD, PhD

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: October 19, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 1, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share

Locations

PL (1)