Methylnaltrexone as a Method to Improve Ticagrelor Uptake in Morphine Treated STEMI Patients

NCT02942550 | Completed Phase 4

• 1 other identifier: 880526
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 2

Brief Summary

This study will examine the impact of the peripheral opioid antagonist methylnaltrexone on the onset of effect of ticagrelor in morphine treated patients with ST elevation myocardial infarction (STEMI). Half of the participants will receive methylnaltrexone, while the other half will receive placebo.

Conditions

STEMI; Morphine; Ticagrelor; Methylnaltrexone

Outcome Measures

Primary Outcomes (2)

• High on-treatment platelet reactivity (HPR)

  HPR defined as platelet reactivity index (PRI) ≥50% using VASP analysis

  Two hours after the injection of either active drug or placebo

• Number of participants with serious adverse events

  Serious AE is any untoward medical occurrence that at any dose: * Results in death. * Is life-threatening at the time of the event. * Requires inpatient hospitalization. * Requires prolongation of existing hospitalization. * Results in persistent or significant disability/incapacity. * Is a congenital anomaly/birth defect.

  Within 48 hours after drug administration

Secondary Outcomes (5)

• High on-treatment platelet reactivity

  One hour after the injection of either active drug or placebo

• Difference in ticagrelor and AR-C124910XX concentrations

  One and two hours after the injection of either active drug or placebo

• Change in patient pain according to visual analog scale

  One and two hours after the injection of either active drug or placebo

• Difference in ticagrelor and AR-C124910XX concentrations between patients with inferior STEMI and patients with anterior/lateral STEMI.

  One and two hours after the injection of either active drug or placebo

• Difference in high on-treatment platelet reactivity (HPR) between patients with inferior STEMI and patients with anterior/lateral STEMI.

  One and two hours after the injection of either active drug or placebo

Study Arms (2)

Methylnaltrexone

ACTIVE COMPARATOR

Methylnaltrexone bromide (Relistor®). Single intravenous injection of 8 mg (0.4 ml solution) for patients weighing 38-61 kg or 12 mg (0.6 ml solution) patients weighing 62-114 kg).

Drug: Methylnaltrexone bromide (Relistor®).

Placebo

PLACEBO COMPARATOR

Sodium Chloride, 9mg /mL ingle intravenous injection of 0.4 mL solution for patients weighing 38-61 kg or 0.6 mL solution patients weighing 62-114 kg).

Drug: Sodium Chloride 9mg/mL

Interventions

Methylnaltrexone bromide (Relistor®). DRUG

Methylnaltrexone

Sodium Chloride 9mg/mL DRUG

Placebo

Eligibility Criteria

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

You may qualify if:

• Diagnosis of STEMI
• Administration of a 180 mg loading dose ticagrelor
• Analgesic treatment with intravenous morphine pre-PCI

You may not qualify if:

• Cardiac arrest
• Body weight \> 114kg
• Vomiting after intake of ticagrelor loading dose
• Inability to understand study outline and instructions
• Methylnaltrexone bromide contraindication
• Age \<18 years; 8) Women in fertile age
• Treatment with Cangrexal
• Ongoing long-term opioid treatment.

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (2)

Karolinska University Hospital

Stockholm, Sweden

Location

Södersjukhuset (Stockholm South General Hospital)

Stockholm, Sweden

Location

Related Publications (1)

• Holm M, Tornvall P, Henareh L, Jensen U, Golster N, Alstrom P, Santos-Pardo I, Witt N, Fedchenko N, Venetsanos D, Beck O, van der Linden J. The MOVEMENT Trial. J Am Heart Assoc. 2019 Jan 22;8(2):e010152. doi: 10.1161/JAHA.118.010152.

  PMID: 30636504 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

methylnaltrexone; 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)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Per Tornvall, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Ulf Jensen, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Nawzad Saleh, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Loghman Henareh, MD; PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

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: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 21, 2016
• First Posted: October 24, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 9, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)