ST-elevation myocardial infarction MedDRA version: 18.0 Level: LLT Classification code 10064346 Term: STEMI System Organ Class: 100000004849
Conditions
Interventions
Trade Name: Relistor
Product Name: Relistor
Pharmaceutical Form: Solution for injection
INN or Proposed INN: METHYLNALTREXONE BROMIDE
CAS Number: 73232-52-7
Other descriptive name: METHYLNALTREXONE BR
Sponsors
Karolinska Institutet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Diagnosis of STEMI: Presence of typical symptoms, e.g. chest pain for more than 15 minutes together with new ST-segment elevation (>1mm [0.1mV] in two adjoining limb or chest leads, >2mm [0.2mV] in V2 and V3 for men, or >1,5mm [1.5mV] in V2 and V3 for women) in the absence of left ventricular hypertrophy or left branch bundle block (LBBB) on 12-lead ECG; 2) • 180 mg loading dose ticagrelor has been given before initiation of coronary angiography • Analgesic treatment with intravenous morphine has been administered before initiation of coronary angiography Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: • Cardiac arrest • Inability to understand study outline and instructions • Methylnaltrexone bromide contraindication, including o Known hypersensitivity to the active substance or to any of the excipients: - Sodium chloride - Sodium calcium edetate - Glycine hydrochloride - Water for injections - Hydrochloric acid (to adjust pH) - Sodium hydroxide (to adjust pH - Known or suspected mechanical gastro-intestinal obstruction or other acute surgical abdominal conditions • Age <18 years • Women in fertile age • Administration of ticagrelor within 7 days before onset of STEMI symptoms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to randomize morphine treated patients with STEMI to either a peripheral acting opioid antagonist or placebo in order to assess if a faster onset of platelet inhibition can be achieved after a loading dose of 180 mg ticagrelor.;Secondary Objective: To assess if the concentrations of ticagrelor and its active metabolite AR-C124910XX are increased for morphine treated patients with STEMI receiving a peripheral acting opioid antagonist compared with placebo. To assess if a faster onset of platelet inhibition can be achieve without a central opioid antagonist effect, through measurements using visual analogue scale.;Primary end point(s): Incidence of high on-treatment platelet reactivity (HPR) after inclusion and randomization.;Timepoint(s) of evaluation of this end point: 2h post drug randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): *Plasma concentration of ticagrelor and AR-C124910XX *Correlation between morphine levels in plasma with platelet inhibition, ticagrelor- and AR-C124910XX concentrations, respectively. ;Timepoint(s) of evaluation of this end point: 1 and 2 hours after randomization | — |
Countries
Sweden
Contacts
Public ContactClinical trial information
Karolinska Institutet
Outcome results
None listed