Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02942550
Other study ID # 880526
Secondary ID
Status Completed
Phase Phase 4
First received September 21, 2016
Last updated April 5, 2018
Start date November 2016
Est. completion date December 2017

Study information

Verified date April 2018
Source Karolinska University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 82
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Methylnaltrexone bromide (Relistor®).

Sodium Chloride 9mg/mL


Locations

Country Name City State
Sweden Karolinska University Hospital Stockholm
Sweden Södersjukhuset (Stockholm South General Hospital) Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 High on-treatment platelet reactivity One hour after the injection of either active drug or placebo
Secondary Difference in ticagrelor and AR-C124910XX concentrations One and two hours after the injection of either active drug or placebo
Secondary Change in patient pain according to visual analog scale One and two hours after the injection of either active drug or placebo
Secondary 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
Secondary Difference in high on-treatment platelet reactivity (HPR) between patients with inferior STEMI and patients with anterior/lateral STEMI. HPR defined as platelet reactivity index (PRI) =50% using VASP analysis One and two hours after the injection of either active drug or placebo
See also
  Status Clinical Trial Phase
Not yet recruiting NCT02871622 - BMX Alpha Registry: a Post-market Registry of the BioMatrix Alpha TM N/A
Completed NCT01452139 - Pharmacogenetic Approach to Anti-platelet Therapy for the Treatment of ST-segment Elevation Myocardial Infarction (STEMI) Phase 2/Phase 3
Completed NCT01325116 - Delayed Educational Reminders in Acute Myocardial Infarction (MI) N/A
Completed NCT01625104 - Randomized Trial of a Quality Improvement Intervention to Decrease D2B Time in Primary PCI for AMI N/A
Completed NCT04023266 - A Pilot Randomized Controlled Trial of Intravenous N-acetyl Cysteine in STEMI Phase 2
Completed NCT02170103 - Microvascular Recovery With Ultrasound in Myocardial Infarction (MRUSMI) Post PCI Trial N/A
Completed NCT03103620 - Safety and Effectiveness Evaluation of COBRA PzF Coronary Stent System: A Post Marketing Observational Registry
Not yet recruiting NCT05975567 - Deploying Novel Imaging Modalities Towards a Three-dimensional (3D) CARDIOvascular PATHology
Enrolling by invitation NCT03328156 - Erectile Dysfunction After Percutaneous Coronary Intervention Versus the Thrombolytic Therapy in Acute ST Elevation Myocardial Infarction N/A
Completed NCT04017169 - No Reflow Phenomenon Incidence and Predictors
Completed NCT03470441 - A Study of Acute Myocardial Infarction Using FDY-5301 Phase 2
Active, not recruiting NCT01433627 - Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX Phase 3
Completed NCT01197742 - Sweetheart-Register: Risk Management of Diabetics With Acute Myocardial Infarction N/A
Terminated NCT03439150 - Resistance STEMI Study N/A
Recruiting NCT03998319 - A Study of Low-dose Intracoronary Thrombolytic Therapy in STEMI (Heart Attack) Patients. Phase 3
Not yet recruiting NCT05974930 - Intravascular ULTRAsound-Guided PCI in Patients With ST-Elevation Myocardial Infarction
Active, not recruiting NCT03102723 - Platelet Inhibition to Target Reperfusion Injury Phase 2
Completed NCT03930589 - Remote Ischemic Conditioning in STEMI to Decrease Infarct Size N/A
Not yet recruiting NCT04912167 - The Effects of Sacubitril-Valsartan vs Enalapril on Left Ventricular Remodeling in ST-elevation Myocardial Infarction Phase 3
Recruiting NCT02604394 - Rheolytic Thrombectomy in Patients With Acute STEMI and Large Thrombus Burden N/A