Comparison of Clinical Outcomes of Standard-Dose and Reduced-Dose Tenecteplase in Patients with Acute Ischemic Stroke

comparison of clinical outcomes resulting from the use of standard(0/9 mg/kg) and reduced dose of Tenecteplase(2/3 of standard dose) in acute ischemic stroke patients from dey 1404 to dey 1405

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20251213068308N1

Enrollment

220

Registered

2025-12-16

Start date

2025-12-22

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Ischemic Stroke. Cerebral infarction

Interventions

Intervention 1: Intervention group: Patients receive intravenous tenecteplase at a reduced dose of two-thirds of the standard dose (0.25 mg/kg) as a single intravenous bolus over 5–10 seconds. Both in

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients eligible for intravenous thrombolytic therapy according to the 2019 AHA/ASA guidelines

Exclusion criteria

Exclusion criteria: Patients who do not meet the eligibility criteria for intravenous thrombolytic therapy according to the 2019 AHA/ASA guidelines Patients who do not provide informed consent to participate in the study

Design outcomes

Primary

Measure	Time frame
Therapeutic outcome based on National Institutes of Health Stroke Scale score. Timepoint: At baseline, one week after intervention, at hospital discharge, and three months after intervention. Method of measurement: Using the National Institutes of Health Stroke Scale assessment conducted by trained clinicians.;Incidence of hemorrhagic complications and symptomatic intracerebral hemorrhage. Timepoint: Within 24 hours and during hospital stay. Method of measurement: Clinical evaluation and brain imaging (CT or MRI).;In-hospital mortality. Timepoint: During hospital stay. Method of measurement: Recorded from hospital records.;Therapeutic outcome based on Modified Rankin Scale score. Timepoint: Three months after intervention. Method of measurement: Using the Modified Rankin Scale assessment by trained clinicians.;Three-month post-discharge mortality. Timepoint: Three months after discharge. Method of measurement: Telephone follow-up and hospital records.;Total mortality. Timepoint: During hospital stay and three months post-discharge. Method of measurement: Combined in-hospital and post-discharge mortality data from records and follow-up.	—

Measure

Time frame

Therapeutic outcome based on National Institutes of Health Stroke Scale score. Timepoint: At baseline, one week after intervention, at hospital discharge, and three months after intervention. Method of measurement: Using the National Institutes of Health Stroke Scale assessment conducted by trained clinicians.;Incidence of hemorrhagic complications and symptomatic intracerebral hemorrhage. Timepoint: Within 24 hours and during hospital stay. Method of measurement: Clinical evaluation and brain imaging (CT or MRI).;In-hospital mortality. Timepoint: During hospital stay. Method of measurement: Recorded from hospital records.;Therapeutic outcome based on Modified Rankin Scale score. Timepoint: Three months after intervention. Method of measurement: Using the Modified Rankin Scale assessment by trained clinicians.;Three-month post-discharge mortality. Timepoint: Three months after discharge. Method of measurement: Telephone follow-up and hospital records.;Total mortality. Timepoint: During hospital stay and three months post-discharge. Method of measurement: Combined in-hospital and post-discharge mortality data from records and follow-up.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSara Kianmehr

Zanjan University of Medical Sciences

Kianmehr.sara94@gmail.com+98 24 3377 0801

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026