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Study of Tenecteplase Versus Alteplase for Thrombolysis (Clot Dissolving) in Acute Ischemic Stroke

NCT01949948 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1050

Last updated 2017-05-09

No results posted yet for this study

Summary

BACKGROUND: Alteplase dissolves blood vessel clots in acute ischemic stroke and is the only approved acute drug treatment \<4½ hours of stroke onset. The overall benefit from alteplase is substantial, but up to 2/3 of patients with large artery clots may not achieve reopening of the vessel and up to 40% of the patients may remain severely disabled or die, leaving substantial room for improvement. Tenecteplase, widely used in coronary heart disease, may be more effective and may have less bleeding complications than alteplase, and may be the drug of choice also in stroke.

HYPOTHESIS: Tenecteplase may be given safely to patients with acute ischemic stroke at a dose that is associated with improved clinical outcome compared with existing treatment options.

AIMS: To compare efficacy and safety of tenecteplase vs. alteplase given \<4½ hours after symptom onset.

STUDY ENDPOINTS: The primary study endpoint is excellent clinical outcome at 3 months (effect). Secondary study endpoints are major early clinical improvement (effect) and bleeding complications (safety).

Conditions

Interventions

DRUG

Tenecteplase

0.4 mg/kg single bolus intravenously

DRUG

Alteplase

0.9 mg/kg as 10% bolus + 90% infusion/60 minutes intravenously

Sponsors & Collaborators

  • The Research Council of Norway

    collaborator OTHER

  • Lars Thomassen

    lead OTHER

Principal Investigators

  • Lars Thomassen, MD PhD Prof. · Dept. Neurology, Haukeland University HospitalBergen, Norway

  • Ulrike Waje-Andreassen, MD PhD Prof. · Dept. Neurology, Haukeland University Hospital, Bergen

  • Nicola Logallo, MD PhD · Dept. Neurology, Haukeland University Hospital, Bergen, Norway

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01949948 on ClinicalTrials.gov