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StrokePhase 2NCT00252239

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

A Phase 2 study testing tenecteplase and tissue plasminogen activator, tPA in people with Stroke, run by University of Virginia at 9 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
tenecteplase and tissue plasminogen activator, tPA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
9 sitesUnited States
Study dates
Nov 2005to Sep 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with at least a serious, measurable deficit on the NIH Stroke Scale in language (aphasia score > 1), motor power (arm or leg > 1), vision (best visual score > 2), or attention (attention score > 2). Thus eligible patients may have a minimum total score of 1 if the deficit is in language or motor power. There is no maximum score that is exclusionary; even patients with severe hemispheric or brainstem deficits will be eligible, as is current practice with intravenous rt-PA. Patients with all ischemic stroke types and in all vascular distributions are eligible.
  • 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.

Who cannot join

  • 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
Show all 20Show fewer
  • </= 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.
  • Patients with a seizure at onset of stroke thought to be presenting with post-ictal paralysis mimicking stroke.
  • Patients with pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations.
  • Patients who have received any other investigational drug within 14 days.
  • Patients who have large areas (greater than one lobe) of obvious low density on the baseline CT scan will be presumed to have had ongoing cerebral ischemia for greater than 3 hours, and will, therefore, be excluded. Patients with subtle early signs of cerebral infarction (e.g., sulcal effacement, blurring of the grey-white junction, asymmetry of the basal ganglia, insular ribbon sign, and others) and the dense artery sign on baseline CT scan will be eligible. Similarly, evidence of previous remote cerebral infarction on baseline CT will not be exclusionary.
  • Patients for whom informed consent cannot be obtained.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109-0316

  • Johns Hopkins-Bayview Medical Center

    Baltimore, Maryland, 21224

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • Colorado Neurological Institutes

    Englewood, Colorado, 80113-2771

  • University of Texas at Houston

    Houston, Texas, 77030

  • Long Island Jewish Hospital

    New Hyde Park, New York, 11040

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Columbia University, Statistical Analysis Center

    New York, New York, 10032

  • University of California at San Diego

    San Diego, California, 92103-8466

Other trials in United States

About this study

Official title: Phase 2B Study of Tenecteplase (TNK) in Acute Ischemic Stroke (TNK-S2B)

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).

Read the detailed description

Stroke is the third leading cause of death and a leading cause of adult disability in the United States and worldwide. To date, the only scientifically-proven and FDA-approved treatment for acute stroke is the clot-busting drug, tissue plasminogen activator (tPA). A newer clot-busting drug, tenecteplase (TNK), has chemical properties that make it a potentially safer and more effective drug for treating stroke. Preliminary testing of TNK in patients with acute stroke has been encouraging enough to warrant further testing.

This study, TNK-S2B, will compare three different doses of TNK with standard tPA treatment in patients with acute stroke. Patients will be chosen randomly to receive either TNK or tPA. Neither the patient nor his/her doctor will know which medication the patient received until the study is completely finished.

The first part of the study will look at results of treatment in the first 24 hours to select the best dose of TNK to carry forward into a more detailed comparison with standard tPA treatment. After at least 100-150 pairs of the best dose of TNK and tPA patients have been enrolled, entry into the study will pause, and the outcomes at 3 months after stroke will be compared to see if the results of TNK treatment are sufficiently promising as an improvement over standard treatment to justify expanding the study to find a definitive answer.

The study, which will be conducted in at least 8 large medical centers, is expected to last about 3 years.

Conditions
Stroke
Being tested
tenecteplase, tissue plasminogen activator, tPA
Keywords
stroke, tenecteplase, TNK, ischemic, tissue plasminogen activator, tPA
Medical subject headings
Stroke, Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tenecteplaseDrug

    Also called TNK

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

  • tissue plasminogen activator, tPADrug

    Also called tPA

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

Study groups in NCT00252239
Study groupRoleWhat they receive
1Active comparatortenecteplase
Receives: Drug: tenecteplase
2Active comparatortissue plasminogen activator, tPA
Receives: Drug: tissue plasminogen activator, tPA

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2005 (estimated)
  2. Study startNov 2005
  3. Primary completionMar 2009
  4. Study completionSep 2009

Why it stopped: Slow enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00252239
Sponsor's protocol ID
11231
Other IDs
R01NS045170, R01NS037666
Status last verified
Feb 2015
First submitted
10 Nov 2005
Last updated
17 Mar 2015
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 20185783

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing tenecteplase and tissue plasminogen activator, tPA in people with Stroke, run by University of Virginia at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Handicap (Modified Rankin Score) (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00252239, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2015.

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