What side effects are associated with this type of intervention?

Common side effects of thrombolytic agents like TNK-tPA (Tenecteplase), which are used to treat strokes by dissolving blood clots, include bleeding complications such as intracranial hemorrhage, gastrointestinal bleeding, and minor bleeding at puncture sites. Other potential side effects may include allergic reactions, hypotension, and reperfusion arrhythmias.

What prior FDA approvals exist?

The FDA has approved several thrombolytic agents for the treatment of stroke, with Alteplase (tPA) being the most widely recognized for acute ischemic stroke. Alteplase works by converting plasminogen to plasmin, thereby dissolving blood clots. Tenecteplase (TNK-tPA), a similar thrombolytic agent, is currently being studied for its potential benefits in treating minor strokes and transient ischemic attacks (TIAs). Both agents aim to restore blood flow by breaking down clots, which is crucial in the early management of ischemic stroke.

What other types of research exist?

Promising novel alternatives to TNK-tPA for stroke patients include: 1) Alteplase (tPA), which is another thrombolytic agent already in use but with ongoing improvements in administration protocols. 2) Desmoteplase, a thrombolytic derived from vampire bat saliva, which has shown potential in clinical trials. 3) Mechanical thrombectomy devices, which physically remove clots and are increasingly used in conjunction with thrombolytic therapy. 4) Newer anticoagulants and antiplatelet agents that are being developed and tested for efficacy in acute stroke management.

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Thrombolytic Agent

Tenecteplase for Ischemic Stroke (TEMPO-2 Trial)

Phase 3

Waitlist Available

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pre-stroke independent functional status - structured mRS ≤2

TIA or minor stroke defined as a baseline NIHSS ≤ 5 at the time of randomization. Patients do not have to have persistent demonstrable neurological deficit on physical neurological examination

Must not have

Patient has a severe or fatal or disabling illness that will prevent improvement or follow-up or such that the treatment would not likely benefit the patient

Planned thrombolysis with IV tPA or endovascular thrombolysis/thrombectomy treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests a single IV dose of Tenecteplase (TNK-tPA) in patients who had a minor stroke or TIA recently. The goal is to see if this drug can help break down blood clots and improve outcomes compared to standard treatments. Patients will be monitored closely to assess the effectiveness and safety of the treatment. Tenecteplase (TNK) is a newer treatment option with specific benefits over older treatments.

Who is the study for?

Adults (18+) who've had a minor stroke or TIA within the last 12 hours, with an NIHSS score ≤5. They must have had independent function before the stroke and show evidence of specific types of blockage in brain arteries on imaging tests. Pregnant individuals, those with recent major surgery or bleeding issues, and patients on certain blood thinners are excluded.

What is being tested?

The trial is testing Tenecteplase (TNK-tPA), a drug given through IV to treat strokes by dissolving blood clots versus standard care which may include antiplatelet drugs. Participants will be randomly assigned to receive either TNK-tPA or physician's choice of standard treatment.

What are the potential side effects?

Tenecteplase can cause bleeding problems, allergic reactions, and might lead to reperfusion injuries where restored blood flow could damage tissues. Antiplatelet treatments can increase the risk of bleeding and sometimes cause stomach upset or rash.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was independent in daily activities before my stroke.

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I had a minor stroke or TIA with little to no lasting effects.

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I am an adult who has had a stroke caused by a blood clot.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My illness is severe and treatment is unlikely to help.

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I am scheduled for a clot-dissolving treatment.

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I haven't had serious bleeding issues in the last 3 months.

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I haven't had major surgery in the last 3 months that could cause serious bleeding.

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I have had a serious brain bleed in the past.

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I have recently been treated with GP2b3a inhibitors.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Modified Rankin Scale (mRS)

Secondary study objectives

Major Bleeding

Other study objectives

Complete or partial recanalization

Lawton Instrumental Activities of Daily Living Scale (IADL)

Quality of life measured on EuroQol38

Side effects data

From 2023 Phase 4 trial • 609 Patients • NCT02777580

cardiogenic shock

heart failure

reinfarction

myocardial rupture

intracranial hemorrhage

ventricular tachycardia

ventricular fibrillation

ischemic stroke

Pneumonia

acute ventricle septum defect

atrial fibrillation

major nonintracranial bleeding

100%

80%

60%

40%

20%

Study treatment Arm

Pharmaco-invasive Strategy

Standard Primary PCI

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Tenecteplase (tNK)Experimental Treatment1 Intervention

Experimental: TNK-tPA (0.25mg/kg) given as a single, intravenous bolus immediately upon randomization. Experimental treatment will be administered as a single intravenous bolus over 1-2 minutes as per the standard manufacturers' instructions for use. Tenecteplase, a genetically engineered mutant tissue plasminogen activator, has a longer half-life, is more fibrin specific, produces less systemic depletion of circulating fibrinogen, and is more resistant to plasminogen activator inhibitor than alteplase.

Group II: Control (Antiplatelet Agents)Active Control1 Intervention

Control: Patients will be treated with standard of care based antiplatelet treatment - choice at the discretion of the investigator. Low dose aspirin (single agent) will be the choice of most physicians, some will chose to use the combination of aspirin and clopidogrel. As this is a multi-centre, international trial where local practices will vary, rather than mandating a specific antiplatelet agent, we will allow the local investigator to chose which antithrombotic regime should be used. Standard of care medication(s) should be given immediately upon randomization.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tenecteplase

2020

Completed Phase 4

~6200

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Thrombolytic agents like TNK-tPA (Tenecteplase) are commonly used in the treatment of stroke. They work by converting plasminogen to plasmin, an enzyme that dissolves fibrin, the primary component of blood clots. This action helps to restore blood flow to the brain, reducing the extent of brain damage. For stroke patients, timely administration of these agents is critical as it can significantly lower the risk of long-term disability and death by quickly re-establishing circulation in the affected areas.