A Phase 4 interventional study of alteplase or tenecteplase in Ischemic Stroke, Acute and Ischemic Stroke, sponsored by Oman Ministry of Health. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Oman Ministry of Health · Phase 4, Interventional, and Treatment
The goal of this study is to establish and examine the efficacy of using a Telestroke network in Oman to facilitate using emergent thrombolysis for patients with acute ischemic stroke encountered in selected peripheral hospitals. It is proposed to establish a TeleStroke network involving two central hospitals in Muscat linked to three to five peripheral hospitals in Oman which currently have access to CT scans and basic infrastructure for management of AIS patients- but do not have a Neurology service. Selected staff from Internal Medicine/Emergency Medicine departments, Nursing, Technical service and support staffs will be trained in the process of assessment and management of AIS patients including the use of IV alteplase or tenecteplase. They will also be trained in timely access of a Neurologist on call at the central hospital(s) using a TeleStroke network. The Neurologist would conduct a Telestroke based clinical assessment of the AIS patient, review imaging and laboratory results in a timely manner and advice the medical team at the peripheral hospital regarding administration of IV alteplase/tenecteplase. The main purpose of such consultation would be to recognize eligible patients for administration of IV thrombolysis safely at the earliest opportunity within 4.5 hours, leading to increased rates of such thrombolysis with expected improved outcomes. Outcomes would be compared among 100 patients with AIS managed across these 5 hospitals prior to initiation of the practice of thrombolysis and at least 100 patients treated each with IV alteplase using TeleStroke Consultation with Neurologist. Demonstration of efficacy of TeleStroke based stroke thrombolysis would lead to effective implementation of this practice in Oman.
Stroke is the second leading cause of death globally and the primary cause of long-term disability. Timely management of acute ischemic stroke (AIS) requires emergent administration of intravenous thrombolytics (alteplase or tenecteplase) within 4.5 hours of symptom onset, often followed by triage for possible thrombectomy. However, many peripheral hospitals, particularly in regions like Oman, lack the specialized neurological expertise necessary for this time-sensitive management.
Telemedicine, specifically 'TeleStroke,' has emerged as a crucial solution in numerous countries and communities to bridge this gap, enabling remote neurological support for acute stroke thrombolysis. The Oman TeleStroke Initiative aims to establish and evaluate the efficacy of such a network.
Study Objectives:
This study aims to:
Establish a TeleStroke 'hub' center within one or two major hospitals in Muscat with existing neurologic services.
Develop 'spoke' TeleStroke centers in five peripheral hospitals (Rustaq, Ibra, Buraimi, Ibri, and Sur) by identifying and engaging multidisciplinary participating teams (Internal Medicine, Emergency Medicine, Imaging, Laboratory, Nursing, Technical support).
Train senior physician-led teams at spoke hospitals in TeleStroke-based acute stroke management protocols, specifically focusing on intravenous thrombolysis.
Educate broader medical and paramedical teams in overall acute stroke management and decision-making processes.
Sequentially initiate acute stroke thrombolysis services at peripheral centers following a stepped-wedge trial model.
Conduct 3-5 mock TeleStroke-based stroke thrombolysis cycles at each peripheral center to ensure readiness and troubleshoot protocols.
Support and monitor 20 stroke care encounters for thrombolysis at each spoke center.
Document demographic data, stroke type and severity (NIH Stroke Scale, GCS), main neurologic deficits, risk factors, discharge outcome (neurologic deficits; NISS; modified Rankin Score), and 3-month outcome for two patient groups at each center: 30 patients receiving conventional management before TeleStroke initiation and 20 patients after TeleStroke-facilitated thrombolysis.
Conduct a comprehensive cost-benefit analysis.
Compare outcomes and cost-benefit between cohorts before and after TeleStroke initiation.
Facilitate handover of the project to a standing committee managed by participating hospitals upon project completion.
Study Design and Setting:
This is an implementation study utilizing a stepped-wedge randomized trial model. The project will establish a TeleStroke network comprising one or two expert 'hub' hospitals in Muscat linked to five 'spoke' hospitals in the periphery (Rustaq, Ibra, Buraimi, Ibri, and Sur). The sequential initiation of thrombolysis services at spoke centers under TeleStroke guidance will allow for observation of conventional management (control phase) followed by the intervention phase at each site.
Intervention and Training:
The intervention involves the implementation of a TeleStroke network and comprehensive training. At peripheral hospitals, 2-3 dedicated senior physicians from Internal Medicine and Emergency Medicine will be trained in acute stroke management, focusing on thrombolytic care. This training will include didactic lectures, case discussions, hands-on sessions (e.g., NIH Stroke Scale administration), CT evaluation in acute stroke, thrombolysis decision-making, post-thrombolysis care, and communication skills. Related medical and paramedical teams (Nursing, Physical Medicine) will also receive training in overall acute stroke and post-stroke patient management. Essential IT infrastructure (computers with audio-video, image/lab upload capabilities) will be provided, and a dedicated computer application for systematic communication and documentation will be adapted. Mock encounters will be practiced at each center to refine protocols and achieve short door-to-needle times.
Key Management Steps:
Eligible patients will undergo a rapid assessment including focused history ("last known to be normal" time), neurological exam (NIHSS, GCS), vital signs, and urgent investigations (blood glucose, CBC, U\&E, ECG, CT brain plain, with CTA if available). If eligible for IV alteplase, consent will be obtained, and a TeleStroke consultation with a neurologist will be initiated. The remote neurologist will confirm eligibility, review imaging and labs, confirm consent, recommend the alteplase dose (0.9 mg/kg total, 10% bolus over 2 min, remainder over 1 hour), and guide post-dosing care. Patients will be monitored for BP, sensorium, deficits, and hemorrhage, with repeat CT at 24 hours or earlier if worsening. Patients with poor neurological status or complications may be transferred to a central hospital for expert care. Follow-up will extend to 3 months.
Endpoints of Interest:
Primary Outcomes:
Rate of utilization of IV alteplase thrombolysis for AIS at peripheral hospitals.
3-month clinical outcomes (Good=mRS 0-2; Poor=mRS 3-6) comparing control and rtPA groups.
Rates of intracranial or systemic hemorrhage.
Secondary Outcomes:
Discharge clinical outcomes (Good=mRS 0-2; Poor=mRS 3-6) comparing control and rtPA groups.
Time from patient arrival to initiation of TeleStroke Consult.
Door-to-Needle time for rtPA administration.
Rates of TeleStroke Consultations for acute stroke from peripheral hospitals.
Frequency of patient transfers to central hospitals.
Frequency of ICU admissions required.
Estimated cost of care: Comparison among Controls and rtPA Groups.
Statistical Analysis:
A stepped-wedge randomized model will guide implementation. Data from 30 patients managed conventionally will be documented at each center prior to thrombolysis initiation. After at least 20 thrombolysis encounters per peripheral hospital, overall outcomes will be analyzed. Continuous variables will be summarized using means/SDs or medians/quartiles, and categorical variables using frequencies/percentages. Analyses will be 2-tailed (p\<0.05) using SPSS-21. Univariate methods will compare endpoints, and logistic regression will explore factors influencing outcomes. Cost-benefit analysis will compare TeleStroke-based management to conventional methods.
Significance to Oman and Benefits:
This initiative addresses a critical gap in acute ischemic stroke care by extending access to thrombolysis, currently largely inaccessible in many Omani peripheral communities. Successful implementation will align Omani stroke care with current international standards, potentially reducing stroke-related mortality and long-term morbidity. The expected reduction in long-term disability care costs is anticipated to offset program implementation and management expenses. This project will also foster ongoing skilled manpower development in acute care, telemedicine, and TeleStroke technology within Oman. While replicating studies conducted elsewhere, this research is vital to address local limitations such as telecommunications access, technological constraints, and community/hospital acceptability specific to Oman.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 200 is above the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Oman Ministry of Health is the lead sponsor of 18 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Relative : (may consider IV alteplase on individual evaluation).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This arm includes patients with Acute ischemic stroke treated with thrombolysis using TeleStroke consultation
Drug: alteplase or tenecteplase
This arm includes age, gender matched patients with Acute Ischemic stroke who are not treated by thrombolysis.
Thrombolysis using TeleStroke consultation with Neurologist
Also known as: rt-PA, TNK
90 day outcome
Clinical outcome on modified Rankin Score at 90 days. This scale rates outcome from 0 to 6, with 0=no symptoms, 5=bed bound requiring assistance, 6=dead.
Time frame: 90 days
Discharge Outcome
Clinical outcome on modified Rankin Score at discharge from hospital (assessed up to 5 days). This scale rates outcome from 0 to 6, with 0=no symptoms, 5=bed bound requiring assistance, 6=dead.
Time frame: At discharge (assessed up to 5 days)
Rate of Thrombolysis
Rate of utilization of IV alteplase / tenecteplase thrombolysis for acute ischemic stroke at peripheral hospitals
Time frame: At admission and initial management- 2 hours
Intracranial Hemorrhage Rate
Rate of symptomatic intracranial hemorrhage at 24 hours of IV thrombolysis
Time frame: 24 hours
Door to Needle time
Time from Triage arrival of patient to time IV thrombolysis is initiated
Time frame: 1 hour
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — After completion of study, anonymized IPD data can be shared on request by eligible researchers.
Supporting information: Statistical analysis plan, Clinical study report
Time frame: Dec 2026 to Dec 2027
Access criteria: After completion of study, anonymized IPD data can be shared on request by eligible researchers.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Oman Ministry of Health