Study of Tenecteplase (TNK) in Acute Ischemic Stroke (TNK-S2B)

NCT00252239 | Terminated Phase 2 Results DMC

• 3 other identifiers: 11231R01NS045170R01NS037666
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of this study is to determine which of 3 different doses of tenecteplase (TNK) is better for treating stroke patients and if TNK offers an advantage over currently available treatment with tissue plasminogen activator (tPA).

Conditions

Stroke

Keywords

stroke; tenecteplase; TNK; ischemic; tissue plasminogen activator; tPA

Outcome Measures

Primary Outcomes (1)

• Functional Handicap (Modified Rankin Score)

  The scale range is from 0 (perfect health without symptoms) to 6 (death). Percentage of participants with Modified Rankin Score \>=4 are reported.

  3 months

Study Arms (2)

1

ACTIVE COMPARATOR

tenecteplase

Drug: tenecteplase

2

ACTIVE COMPARATOR

tissue plasminogen activator, tPA

Drug: tissue plasminogen activator, tPA

Interventions

tenecteplase DRUG

This study will compare 3 different doses of tenecteplase to tPA.

Also known as: TNK

1

tissue plasminogen activator, tPA DRUG

To date, tissue plasminogen activator (tPA) is the only scientifically-proven and FDA-approved treatment for acute stroke.

Also known as: tPA

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must arrive at participating hospital and treatment begun within 3 hours of the onset of symptoms. Patients awakening with new symptoms must use the time last observed to be normal and awake and the total time cannot exceed three hours prior to treatment as the time of onset.
• Must be 18 years of age or older.

You may not qualify if:

• Patients with a) minor stroke symptoms (e.g., sensory loss, ataxia, dysarthria, or facial weakness alone) or b) major symptoms which are rapidly improving by the time of treatment.
• Patients for whom a complete NIH Stroke Score cannot be obtained (e.g., intubated patients or complete amputees).
• Patients with evidence of intracranial hemorrhage on pretreatment CT scan.
• Patients with a clinical presentation that suggests subarachnoid hemorrhage, even if the initial CT scan is normal.
• Patients who are known or suspected to be pregnant.
• Patients with a known bleeding diathesis or patients with a platelet count \< 100,000. For patients who are taking oral Warfarin (Coumadin), the results of the pretreatment International Normalized Ratio (INR) must be available prior to treatment and must be
• \</= 1.4. Patients who have received heparin within 48 hours must have a normal partial thromboplastin time (PTT) to be eligible. Patients who have received low molecular weight heparin or heparinoid within 24 hours are also excluded.
• Patients with major surgery or serious trauma excluding head trauma within 14 days or serious head trauma within 3 months.
• Patients with a history of gastrointestinal or urinary tract hemorrhage in the previous 21 days.
• Patients with an arterial puncture at a non-compressible site or a lumbar puncture in the previous 7 days.
• Patients who, on repeated measurement, have a systolic blood pressure \> 185, or a diastolic blood pressure \> 110 mmHg when treatment is to begin, or require aggressive treatment to reduce blood pressure to within these limits.
• Patients with a history of stroke in the previous 3 months or have ever had an intracranial hemorrhage considered to put them at increased risk for intracranial hemorrhage.
• Patients with a serious medical illness likely to interfere with treatment or treatment might adversely affect that illness.
• Patients with abnormal blood glucose thought to account for the neurological deficit.
• Patients with a clinical presentation consistent with acute myocardial infarction or patients with presentation suggesting post-myocardial infarction pericarditis.

Sponsors & Collaborators

• University of Virginia: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (9)

University of California at San Diego

San Diego, California, 92103-8466, United States

Location

Colorado Neurological Institutes

Englewood, Colorado, 80113-2771, United States

Location

Johns Hopkins-Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109-0316, United States

Location

Long Island Jewish Hospital

New Hyde Park, New York, 11040, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Columbia University, Statistical Analysis Center

New York, New York, 10032, United States

Location

University of Texas at Houston

Houston, Texas, 77030, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

• 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: 20185783 DERIVED

MeSH Terms

Conditions

Stroke; Ischemia

Interventions

Tenecteplase; Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Limitations and Caveats

Premature termination limits any conclusions from the trial.

Results Point of Contact

• Title: Dr. E. Clarke Haley, Jr.
• Organization: University of Virginia Health System

ech@virginia.edu

434-924-8041

Study Officials

• E. Clarke Haley, Jr., M.D.

  Clinical Coordinating Center, Department of Neurology, University of Virginia Health System

  PRINCIPAL INVESTIGATOR

• John L. P. Thompson, Ph.D.

  Statistical Analysis Center, Department of Biostatistics, Mailman School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Neurology

Study Record Dates

• First Submitted: November 10, 2005
• First Posted: November 11, 2005
• Study Start: November 1, 2005
• Primary Completion: March 1, 2009
• Study Completion: September 1, 2009
• Last Updated: March 17, 2015
• Results First Posted: January 19, 2015

Record last verified: 2015-02

Locations

US (9)