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Comparison of thrombolytic therapy with Alteplase and Tenecteplase

Comparison of thrombolytic therapy with Alteplase and Tenecteplase for in patients with acute ischemic stroke in a clinical trial phase 3.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241023063472N1
Enrollment
100
Registered
2024-11-28
Start date
2025-02-19
Completion date
Unknown
Last updated
2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

stroke. Brain stem stroke syndrome

Interventions

Intervention 1: Intervention group: Patients are randomly selected by an unaware individual and are divided into two intervention groups receiving treatment with alteplase at appropriate doses. Patie

Sponsors

Ahvaz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with acute ischemic stroke treated with alteplase or tenectplase after the onset of symptoms Patient age over 18 years Patients who can receive intravenous thrombolytics within 4.5 hours of ischemic stroke

Exclusion criteria

Exclusion criteria: Patients with hemorrhagic stroke Patient age under 18 years Patients with ischemic stroke without tPA treatment Patients with a history of bleeding disorders, recent surgery or acute comorbidities Patients who have received endovascular thrombectomy Patients with contraindications to tPA and in cases where the risk of bleeding outweighs the benefits of pharmacotherapy (since tPA increases the risk of bleeding, patients with a history of recent intracranial hemorrhage (ICH[1]) or intracranial hemorrhage, subarachnoid hemorrhage , structural vascular lesion of the brain, intracranial neoplasm, active internal bleeding, recent intracranial or intraspinal surgery, uncontrolled high blood pressure and serious head trauma within the past 3 months, may not be able to receive this drug).

Design outcomes

Primary

MeasureTime frame
Stroke severity. Timepoint: 24 hours, 7 days, and 90 days after the initiation of treatment. Method of measurement: Primary Outcome Measure:The number of patients with an mRS score of 0-1 at 3 months.Secondary Outcomes Include:Change in mRS classification at 3 months.Reduction in the National Institutes of Health Stroke Scale (NIHSS) by 8 points or more or achieving a score of 0-1 within 24 hours.Symptomatic intracerebral hemorrhage within 36 hours.Adverse events and mortality within 90 days.

Secondary

MeasureTime frame
Secondary outcomes include changes in mRS classification at 3 months. Timepoint: 3 month. Method of measurement: Primary Outcome Measure:The number of patients with an mRS score of 0-1 at 3 months.Secondary Outcomes Include:Changes in mRS classification at 3 months.A reduction in the National Institutes of Health Stroke Scale (NIHSS) by 8 points or more or achieving a score of 0-1 within 24 hours.Symptomatic intracerebral hemorrhage within 36 hours.;Primary Outcome Measure:The number of patients with an mRS score of 0-1 at 3 months.Secondary Outcomes Include:Changes in mRS classification at 3 months.A reduction in the National Institutes of Health Stroke Scale (NIHSS) by 8 points or more or achieving a score of 0-1 within 24 hours.Symptomatic intracerebral hemorrhage within 36 hours. Timepoint: 3 month. Method of measurement: Secondry outcome variables classification mRS after 3 month.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDavood shalilahmadi

Ahvaz University of Medical Sciences

Pardis.nourbakhsh74@gmail.com+98 61 3573 3118

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026