NCT02217878

Brief Summary

The purpose of the IMPRESSION study is to determine whether intravenous administration of morphine prior to ticagrelor administration in ST-segment elevation myocardial infarction (STEMI) patients and in non-ST-segment elevation myocardial infarction (NSTEMI) patients alters the plasma concentrations of ticagrelor and its active metabolite and whether it is associated with any negative impact on the antiplatelet effect of ticagrelor.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 15, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
9 months until next milestone

Results Posted

Study results publicly available

March 3, 2016

Completed
Last Updated

September 12, 2017

Status Verified

August 1, 2017

Enrollment Period

10 months

First QC Date

August 14, 2014

Results QC Date

February 4, 2016

Last Update Submit

August 12, 2017

Conditions

ST-segment Elevation Myocardial InfarctionNon-ST-segment Elevation Myocardial InfarctionVA Drug Interactions

Keywords

ST-segment elevation myocardial infarctionnon-ST-segment elevation myocardial infarctionticagrelormorphinepharmacokineticspharmacodynamicsdrug interactionsVASP assayMultiple Electrode AggregometryVerifyNow

Outcome Measures

Primary Outcomes (1)

  • Area Under the Plasma Concentration-time Curve for Ticagrelor (AUC 0-12h)

    Exposure to ticagrelor during the first 12 hours after ticagrelor loading dose

    prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose

Secondary Outcomes (37)

  • Area Under the Plasma Concentration-time Curve for AR-C124910XX (AUC 0-12h)

    prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose

  • Maximum Concentration of Ticagrelor

    12 hours

  • Maximum Concentration of AR-C124910XX

    12 hours

  • Time to Maximum Concentration for Ticagrelor

    12 hours

  • Time to Maximum Concentration for AR-C124910XX

    12 hours

  • +32 more secondary outcomes

Study Arms (2)

Morphine

ACTIVE COMPARATOR

morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor

Drug: MorphineDrug: Ticagrelor

Placebo

PLACEBO COMPARATOR

sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor

Drug: PlaceboDrug: Ticagrelor

Interventions

MorphineDRUG

IV bolus injection

Also known as: Morphine sulfate
Morphine
PlaceboDRUG

IV bolus injection

Also known as: Sodium chloride 0,9%
Placebo
TicagrelorDRUG

180 mg loading dose

Also known as: Brilique
MorphinePlacebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • provision of informed consent prior to any study specific procedures
  • diagnosis of acute ST-segment elevation myocardial infarction or acute non-ST-segment elevation myocardial infarction
  • male or non-pregnant female, aged 18-80 years old
  • provision of informed consent for angiography and PCI

You may not qualify if:

  • chest pain described by the patient as unbearable or patient's request for analgesics
  • prior morphine administration during the current STEMI or NSTEMI
  • treatment with ticlopidine, clopidogrel, prasugrel or ticagrelor within 14 days before the study enrollment
  • 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)
  • patients considered by the investigator to be at risk of bradycardic events
  • second or third degree atrioventricular block during screening for eligibility
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology Department, Dr. A. Jurasz University Hospital

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

Location

Related Publications (2)

  • Kubica J, Adamski P, Ostrowska M, Sikora J, Kubica JM, Sroka WD, Stankowska K, Buszko K, Navarese EP, Jilma B, Siller-Matula JM, Marszall MP, Rosc D, Kozinski M. Morphine delays and attenuates ticagrelor exposure and action in patients with myocardial infarction: the randomized, double-blind, placebo-controlled IMPRESSION trial. Eur Heart J. 2016 Jan 14;37(3):245-52. doi: 10.1093/eurheartj/ehv547. Epub 2015 Oct 21.

    PMID: 26491112DERIVED

  • Kubica J, Adamski P, Ostrowska M, Kozinski M, Obonska K, Laskowska E, Obonska E, Grzesk G, Winiarski P, Paciorek P. Influence of Morphine on Pharmacokinetics and Pharmacodynamics of Ticagrelor in Patients with Acute Myocardial Infarction (IMPRESSION): study protocol for a randomized controlled trial. Trials. 2015 Apr 29;16:198. doi: 10.1186/s13063-015-0724-z.

    PMID: 25925591DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

MorphineTicagrelor

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsAdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Results Point of Contact

Title
Prof. Jacek Kubica
Organization
Collegium Medicum, Nicolaus Copernicus University
jkubica@cm.umk.pl
+485854023

Study Officials

  • Prof. Jacek Kubica, MD, PhD

    Collegium Medicum im. Ludwika Rydygiera w Bydgoszczy, Uniwersytet Mikołaja Kopernika w Toruniu

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr hab.

Study Record Dates

First Submitted

August 14, 2014

First Posted

August 15, 2014

Study Start

August 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

September 12, 2017

Results First Posted

March 3, 2016

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)