Effects of Morphine on Loading-dose Ticagrelor in Patients With ST-segment Elevation Myocardial Infarction

NCT02913469 | Unknown Phase 4 DMC

• 1 other identifier: Morphine & Ticagrelor
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

Percutaneous coronary intervention(PCI) has become the first choice for STEMI patients.According to the current guidelines,dual antiplatelet therapy with a P2Y12 receptor inhibitor and aspirin ,and intravenous injection of morphine therapy for chest pain relief in necessity play a pivotal role in the treatment of patients with ST elevation myocardial infarction before primary percutaneous coronary intervention.And ticagrelor is recommended in patients with ST segment elevation myocardial infarction undergoing PCI, with class IB indication.Therefore coadministration of morphine and ticagrelor are commonplace.Currently, some studies have found that morphine delayed and attenuated exposure to ticagrelor,but it is not clear of the pathogenesis of it.Some researchers say that morphine results in a weaker and retarded antiplatelet effect of ticagrelor in STEMI patients before PCI by inhibition of gastrointestinal peristalsis and causing vomiting.The study is aimed at exploring whether morphine delay and attenuate exposure to ticagrelor and its antiplatelet effect.In addition, the trial will explore the possible mechanism which morphne delay and attenuate exposure to ticagrelor in patients with ST-segment elevation myocardial infarction before PCI.

Conditions

ST-segment Elevation Myocardial Infarction

Keywords

Morphine，Ticagrelor，STEMI，PCI

Outcome Measures

Primary Outcomes (1)

• Platelet Reactivity Index(PRI) Measured by VASP-P

  Vasodilator-stimulated phosphoprotein(VASP) phosphorylation, a measure of P2Y12 receptor reactivity, was determined by flow cytometry with the use of the Platelet VASP-FCM Kit (Stago, France)and recorded as the platelet reactivity index

  2 hours after the loading dose of ticagrelor

Secondary Outcomes (2)

• Platelet Reactivity Index (PRI) Measured by VASP-P

  0.5hour,8hours after the loading dose of ticagrelor

• the incidence of major adverse cardiovascular and cerebrovascular events

  follow-up for 30 days after the loading dose of ticagrelor

Study Arms (4)

morphine+metoclopramide

EXPERIMENTAL

administrated intravenous morphine 5mg and metoclopramide 10mg

Drug: Morphine; Drug: metoclopramide

morphine

ACTIVE COMPARATOR

avenous morphine 5mg and 0.9%normal saline 2ml

Drug: Morphine; Drug: saline

metoclopramide

SHAM COMPARATOR

intravenous metoclopramide 10mg and 0.9%normal saline 2ml

Drug: metoclopramide; Drug: saline

placebo

PLACEBO COMPARATOR

intravenous 0.9%normal saline 2mland 0.9%normal saline 2ml

Drug: saline

Interventions

Morphine DRUG

The patients in group A would be administrated intravenous morphine 5mg

Also known as: morphine hydrochloride

morphine; morphine+metoclopramide

metoclopramide DRUG

the patients in group C would be administrated intravenous metoclopramide 10mg

Also known as: Pasprtin

metoclopramide; morphine+metoclopramide

saline DRUG

the patients in group D would be administrated intravenous 0.9%normal saline 2mland 0.9%normal saline 2ml.

Also known as: Physiological Saline

metoclopramide; morphine; placebo

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
• Male or female aged from 18 to 80 years old
• Patients with STEMI scheduled to undergo PCI.

You may not qualify if:

• Hypersensitivity to the active substance or to any of the excipients
• Active bleeding or bleeding diathesis
• Previous transient ischemic attack
• Antiplatelet (clopidogrel, prasugrel, ticagrelor) administration in the week before the index event
• Known relevant hematological conditions
• Left ventricular ejection fraction ≤ 30%
• Renal failure with creatinine ≥ 3 mg/dl
• History of liver disease
• Increased risk of bradycardia
• Concomitant therapy with drugs known to interfere with CYP3A4 metabolism.

Sponsors & Collaborators

• General Hospital of Chinese Armed Police Forces: lead

Study Sites (1)

Cardiology Department, Chinese Armed Police Force Genral Hospital, Beijing China

Beijing, 100039, China

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Morphine; Metoclopramide; Sodium Chloride

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

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; Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• huiliang liu, MD

  CHINESE ARMED POLICE FORCE GENRAL HOSPITAL

  STUDY CHAIR

Central Study Contacts

huiliang liu, MD

CONTACT

+8610 57976707; yueniaodream520@126.com

peng ding, MD

CONTACT

+8615300229301; 562852538@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: September 23, 2016
• Study Start: December 12, 2014
• Primary Completion: August 15, 2020
• Study Completion: August 15, 2020
• Last Updated: March 31, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)