NCT02180204

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2015

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 2, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

5.4 years

First QC Date

June 21, 2014

Last Update Submit

September 22, 2015

Conditions

Ischemic Stroke

Keywords

Cerebral InfarctionIschemic StrokeThrombolysis

Outcome Measures

Primary Outcomes (1)

  • Neurological outcome

    Measured by modified Rankin Scale score

    90 days

Secondary Outcomes (1)

  • Symptomatic intracranial hemorrhage

    24 hours

Study Arms (2)

Tenecteplase

EXPERIMENTAL

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

Drug: Tenecteplase

Alteplase

ACTIVE COMPARATOR

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

Drug: Alteplase

Interventions

TenecteplaseDRUG

Tenecteplase 0.25 mg/kg IV - Maximum 25 mg

Also known as: TNKase
Tenecteplase
AlteplaseDRUG

Alteplase 0.9 mg/kg IV - Maximum: 90 mg

Also known as: Activase, t-PA
Alteplase

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Evidence of intracranial hemorrhage on NECT
  • Clinical suspicion of subarachnoid hemorrhage even with normal NECT
  • NECT shows hypo-density greater than 1/3 cerebral hemisphere)
  • History of intracranial hemorrhage/stroke
  • Uncontrolled HTN: At time treatment begins SBP remains \>185 mmHg or DBP remains \>110 mmHg despite repeated measurements
  • Known arteriovenous malformation, neoplasm, or aneurysm
  • Witnessed seizure at stroke onset
  • Acute bleeding tendencies
  • Platelet count \<100,000/mm3
  • Heparin received in prior 48 hours with elevated aPTT
  • Current use of an anticoagulant (Coumadin/Warfarin) irrespective of INR
  • Prior use (within 48 hours) of direct thrombin inhibitors (dabigatran) or direct factor Xa inhibitors (rivaroxaban, apixaban)
  • Within prior 3 months: intracranial or spinal surgery, head trauma, or previous stroke
  • Arterial puncture at non-compressible site within last 7 days
  • Woman of child bearing age who has a positive pregnancy test
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University College of Medicine

Columbus, Ohio, 43210, United States

Location

Related Publications (7)

  • Parsons M, Spratt N, Bivard A, Campbell B, Chung K, Miteff F, O'Brien B, Bladin C, McElduff P, Allen C, Bateman G, Donnan G, Davis S, Levi C. A randomized trial of tenecteplase versus alteplase for acute ischemic stroke. N Engl J Med. 2012 Mar 22;366(12):1099-107. doi: 10.1056/NEJMoa1109842.

    PMID: 22435369BACKGROUND

  • Parsons MW, Miteff F, Bateman GA, Spratt N, Loiselle A, Attia J, Levi CR. Acute ischemic stroke: imaging-guided tenecteplase treatment in an extended time window. Neurology. 2009 Mar 10;72(10):915-21. doi: 10.1212/01.wnl.0000344168.05315.9d.

    PMID: 19273826BACKGROUND

  • Haley EC Jr, Thompson JL, Grotta JC, Lyden PD, Hemmen TG, Brown DL, Fanale C, Libman R, Kwiatkowski TG, Llinas RH, Levine SR, Johnston KC, Buchsbaum R, Levy G, Levin B; Tenecteplase in Stroke Investigators. Phase IIB/III trial of tenecteplase in acute ischemic stroke: results of a prematurely terminated randomized clinical trial. Stroke. 2010 Apr;41(4):707-11. doi: 10.1161/STROKEAHA.109.572040. Epub 2010 Feb 25.

    PMID: 20185783BACKGROUND

  • Haley EC Jr, Lyden PD, Johnston KC, Hemmen TM; TNK in Stroke Investigators. A pilot dose-escalation safety study of tenecteplase in acute ischemic stroke. Stroke. 2005 Mar;36(3):607-12. doi: 10.1161/01.STR.0000154872.73240.e9. Epub 2005 Feb 3.

    PMID: 15692126BACKGROUND

  • Lees KR, Bluhmki E, von Kummer R, Brott TG, Toni D, Grotta JC, Albers GW, Kaste M, Marler JR, Hamilton SA, Tilley BC, Davis SM, Donnan GA, Hacke W; ECASS, ATLANTIS, NINDS and EPITHET rt-PA Study Group; Allen K, Mau J, Meier D, del Zoppo G, De Silva DA, Butcher KS, Parsons MW, Barber PA, Levi C, Bladin C, Byrnes G. Time to treatment with intravenous alteplase and outcome in stroke: an updated pooled analysis of ECASS, ATLANTIS, NINDS, and EPITHET trials. Lancet. 2010 May 15;375(9727):1695-703. doi: 10.1016/S0140-6736(10)60491-6.

    PMID: 20472172BACKGROUND

  • Behrouz R. Intravenous tenecteplase in acute ischemic stroke: an updated review. J Neurol. 2014 Jun;261(6):1069-72. doi: 10.1007/s00415-013-7102-0. Epub 2013 Sep 15.

    PMID: 24036924BACKGROUND

  • Logallo N, Kvistad CE, Thomassen L. Therapeutic Potential of Tenecteplase in the Management of Acute Ischemic Stroke. CNS Drugs. 2015;29(10):811-8. doi: 10.1007/s40263-015-0280-9.

    PMID: 26387127DERIVED

MeSH Terms

Conditions

Ischemic StrokeCerebral Infarction

Interventions

TenecteplaseTissue Plasminogen Activator

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain InfarctionBrain IschemiaInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Serine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesPlasminogen ActivatorsBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsBiological Factors

Study Officials

  • Reza Behrouz, DO

    The Ohio State University College of Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Neurology

Study Record Dates

First Submitted

June 21, 2014

First Posted

July 2, 2014

Study Start

January 1, 2015

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations

US(1)