- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02942550
Methylnaltrexone as a Method to Improve Ticagrelor Uptake in Morphine Treated STEMI Patients (MOVEMENT)
Methylnaltrexone as a Method to imprOVE Platelet Inhibition of Ticagrelor in Morphine-treated Patients With ST-segMENT Elevation Myocardial Infarction: a Prospective, Single Blinded Randomized, Placebo-controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The rate of drug absorption in the gastro-intestinal tract is often determined by the rate of gastric emptying. Morphine treatment, which is frequently given in order to relieve pain in patients with STEMI, is known to delay gastric emptying, and has indeed emerged as a predictor of delayed/poor antiplatelet response in patients receiving oral prasugrel or ticagrelor.
In recent years, morphine has been found to delay the onset of oral P2Y12-inhibitors. To counteract this, the investigators hypothesized that an opioid antagonist may be used. The opioid antagonist naloxone has previously been shown to reduce the morphine induced delay in gastric emptying However, naloxone crosses the blood-brain barrier (BBB) and reduces the pain relieving effects of morphine. In contrast, the morphine antagonist methylnaltrexone has a reduced passage over the BBB and acts primarily as a peripheral morphine antagonist without affecting the morphine-mediated central analgesic effects.
The aim of the planned study is to evaluate whether methylnaltrexone bromide may reduce the morphine induced delay in onset of platelet inhibition after a loading dose of 180 mg ticagrelor in morphine treated patients with STEMI undergoing primary percutaneous coronary intervention (PCI), where a rapid and adequate platelet inhibition after the administration of ticagrelor is crucial. As morphine is an inclusion criterion, all patients included in the study will be on morphine treatment. Thus, morphine treatment is not an intervention to be administered as part of the protocol. Stratification according to inferior and anterior/lateral STEMI will be perform to avoid imbalance in the location of myocardial infarction between the groups.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Stockholm, Sweden
- Karolinska University Hospital
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Stockholm, Sweden
- Södersjukhuset (Stockholm South General Hospital)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of STEMI
- Administration of a 180 mg loading dose ticagrelor
- Analgesic treatment with intravenous morphine pre-PCI
Exclusion Criteria:
- Cardiac arrest
- Body weight > 114kg
- Vomiting after intake of ticagrelor loading dose
- Use of Naloxone before inclusion or during sampling period
- Inability to understand study outline and instructions
- Methylnaltrexone bromide contraindication
- Age <18 years; 8) Women in fertile age
- Administration of ticagrelor during the week before inclusion
- Treatment with Cangrexal
- Ongoing long-term opioid treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Methylnaltrexone
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).
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Placebo Comparator: Placebo
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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
High on-treatment platelet reactivity (HPR)
Time Frame: Two hours after the injection of either active drug or placebo
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HPR defined as platelet reactivity index (PRI) ≥50% using VASP analysis
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Two hours after the injection of either active drug or placebo
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Number of participants with serious adverse events
Time Frame: Within 48 hours after drug administration
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Serious AE is any untoward medical occurrence that at any dose:
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Within 48 hours after drug administration
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
High on-treatment platelet reactivity
Time Frame: One hour after the injection of either active drug or placebo
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One hour after the injection of either active drug or placebo
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Difference in ticagrelor and AR-C124910XX concentrations
Time Frame: One and two hours after the injection of either active drug or placebo
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One and two hours after the injection of either active drug or placebo
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Change in patient pain according to visual analog scale
Time Frame: One and two hours after the injection of either active drug or placebo
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One and two hours after the injection of either active drug or placebo
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Difference in ticagrelor and AR-C124910XX concentrations between patients with inferior STEMI and patients with anterior/lateral STEMI.
Time Frame: One and two hours after the injection of either active drug or placebo
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One and two hours after the injection of either active drug or placebo
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Difference in high on-treatment platelet reactivity (HPR) between patients with inferior STEMI and patients with anterior/lateral STEMI.
Time Frame: One and two hours after the injection of either active drug or placebo
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HPR defined as platelet reactivity index (PRI) ≥50% using VASP analysis
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One and two hours after the injection of either active drug or placebo
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ulf Jensen, MD, PhD, Karolinska Institutet
- Principal Investigator: Nawzad Saleh, MD, PhD, Karolinska Institutet
- Principal Investigator: Loghman Henareh, MD; PhD, Karolinska Institutet
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Myocardial Infarction
- Infarction
- ST Elevation Myocardial Infarction
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Sensory System Agents
- Narcotic Antagonists
- Anticonvulsants
- Bromides
- Methylnaltrexone
Other Study ID Numbers
- 880526
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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