Tenecteplase Versus Alteplase in Ischemic Stroke Management (TALISMAN)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2020-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a double-blind parallel arm randomized trial aimed to assess efficacy and safety of intravenous Tenecteplase compared to intravenous Alteplase in eligible patients who present with symptoms of acute ischemic stroke within 3 to 4.5 hours from onset.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Thrombolysis Treated With TNK-tPA in Acute Ischemic Stroke Patients （3T Stroke-II）

NCT05281549

Acute Ischemic Stroke

UNKNOWN PHASE2

Thrombolysis Treated With TNK-tPA in Acute Ischemic Stroke Patients （3T Stroke-Ⅲ）

NCT05745259

Acute Ischemic Stroke

UNKNOWN PHASE3

Safety and Efficacy of Alteplase When Administered in Chinese Patients With Acute Ischemic Hemispheric Stroke Where Thrombolysis is Initiated Between 3 and 4.5 Hours After Stroke Onset

NCT02930837

Stroke

COMPLETED PHASE3

Alteplase Compared to Tenecteplase in Patients With Acute Ischemic Stroke

NCT03889249

Stroke, Acute Thromboses, Intracranial

COMPLETED PHASE3

Intra-Arterial Tenecteplase Following Endovascular Thrombectomy for Large Vessel Occlusion Stroke

NCT06781385

Acute Ischemic Stroke

ENROLLING_BY_INVITATION PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients presenting with symptoms of acute ischemic stroke (AIS) who present within 3 to 4.5 hours of symptom onset and who meet the inclusion criteria for intravenous (IV) thrombolysis will receive, in a randomized, double-blind fashion, either IV Alteplase at 0.9 mg/kg per standard protocol or IV Tenecteplase at 0.25 mg/kg with saline infusion over one hour. Patients must also have no exclusion criteria for IV thrombolysis within the 3 to 4.5 hour window. The only required imaging is non-contrasted CT of the head. Patients will be monitored according to standard post-thrombolytic care. A CT of the head will be performed at 24 hours based on standard protocol or if there is any neurological change. Neurological function at 24 hours using NIHSS and at 3 months based on modified mRS and the NIHSS.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ischemic Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Tenecteplase

Tenecteplase 0.25 mg/kg IV - Maximum dose: 25 mg

Group Type EXPERIMENTAL

Tenecteplase

Intervention Type DRUG

Tenecteplase 0.25 mg/kg IV - Maximum 25 mg

Alteplase

Alteplase 0.9 mg/kg IV - Maximum dose: 90 mg

Group Type ACTIVE_COMPARATOR

Alteplase

Intervention Type DRUG

Alteplase 0.9 mg/kg IV - Maximum: 90 mg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tenecteplase

Tenecteplase 0.25 mg/kg IV - Maximum 25 mg

Intervention Type DRUG

Alteplase

Alteplase 0.9 mg/kg IV - Maximum: 90 mg

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

TNKase Activase t-PA

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age 18 to 80 years
2. Acute neurologic deficit with an NIHSS ≥ 4
3. Non-enhanced computed tomography (NECT) of the head showing no hemorrhage
4. Acute ischemic stroke symptoms with onset, or time last known well, clearly defined between 3 and 4.5 hours
5. Treatment can be initiated within 3 to 4.5 hours from symptom onset

Exclusion Criteria

1. Evidence of intracranial hemorrhage on NECT
2. Clinical suspicion of subarachnoid hemorrhage even with normal NECT
3. NECT shows hypo-density greater than 1/3 cerebral hemisphere)
4. History of intracranial hemorrhage/stroke
5. Uncontrolled HTN: At time treatment begins SBP remains \>185 mmHg or DBP remains \>110 mmHg despite repeated measurements
6. Known arteriovenous malformation, neoplasm, or aneurysm
7. Witnessed seizure at stroke onset
8. Acute bleeding tendencies
9. Platelet count \<100,000/mm3
10. Heparin received in prior 48 hours with elevated aPTT
11. Current use of an anticoagulant (Coumadin/Warfarin) irrespective of INR
12. Prior use (within 48 hours) of direct thrombin inhibitors (dabigatran) or direct factor Xa inhibitors (rivaroxaban, apixaban)
13. Within prior 3 months: intracranial or spinal surgery, head trauma, or previous stroke
14. Arterial puncture at non-compressible site within last 7 days
15. Woman of child bearing age who has a positive pregnancy test
16. NIH stroke scale \>25 (severe deficit) or \<4 and no dysphasia (mild deficit) or rapidly improving
17. Symptoms spontaneously clearing
18. 14 days post-operative or post major trauma
19. Recent gastrointestinal or urinary tract hemorrhage within the past 21 days
20. Recent acute MI within the past 3 months
21. Serum glucose \<50 mg/dl or \>400 mg/dL
22. Age \>80 or less than 18
23. History of ischemic stroke AND diabetes mellitus
24. Unable to obtain consent from patient or power of attorney
25. Baseline mRS \> 2
26. Consent not obtained by 20 minutes prior to closure of the therapeutic window.
27. The subject has been treated with a thrombolytic agent within the past 72 hours
28. The subject is a pregnant woman (positive serum βHCG pregnancy test, positive urine pregnancy test or clinically evident pregnancy)
29. The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No