Can methylnaltrexone reduce the morphine induced delay of platelet inhibition by the antiplatelet drug ticagrelor, thereby rendering treatment of myocardial infarction more effective?

• Conditions: ST-elevation myocardial infarction; MedDRA version: 18.0Level: LLTClassification code 10064346Term: STEMISystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-002910-65-SE
• Lead Sponsor: Karolinska Institutet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-08
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

•Cardiac arrest
•Inability to understand study outline and instructions
•Methylnaltrexone bromide contraindication, including
oKnown 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br><br>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 Outcome Measures

Name	Time	Method
Secondary end point(s): *Plasma concentration of ticagrelor and AR-C124910XX <br>*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