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Thrombolytic Agent

Tenecteplase for Ischemic Stroke (TEMPO-2 Trial)

Phase 3
Recruiting
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
Onset (last-seen-well) time to treatment time ≤ 12 hours
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

TEMPO-2 Trial Summary

This trial will enroll patients that have been diagnosed with a transient ischemic attack (TIA) or minor stroke that has occurred within the past 12 hours. Patients will be randomized to TNK-tPA or standard of care. In the intervention group TNK-tPA is given as a single, intravenous bolus (0.25mg/Kg) immediately upon randomization.

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.Check my eligibility
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.See study design
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.

TEMPO-2 Trial 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 started treatment within 12 hours of my symptoms appearing.
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I had a minor stroke or TIA with little to no lasting effects.
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I have a recent blockage in my brain's blood vessels that matches my symptoms.
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I can receive treatment within 90 minutes after my first CT or MRI scan.
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I am an adult who has had a stroke caused by a blood clot.

TEMPO-2 Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Modified Rankin Scale (mRS)
Secondary outcome measures
Major Bleeding
Other outcome measures
Complete or partial recanalization
Lawton Instrumental Activities of Daily Living Scale (IADL)
Quality of life measured on EuroQol38

Side effects data

From 2008 Phase 3 trial • 223 Patients • NCT00396253
2%
Headache
2%
Nausea
1%
Pruritus
1%
Muscle Spasms
1%
Hypertension
1%
Hypotension
1%
Haemodynamic Instability
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tenecteplase

TEMPO-2 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
~4500

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor
780 Previous Clinical Trials
840,460 Total Patients Enrolled
29 Trials studying Stroke
13,012 Patients Enrolled for Stroke
Michael D Hill, MDStudy DirectorUniversity of Calgary
6 Previous Clinical Trials
2,134 Total Patients Enrolled
4 Trials studying Stroke
1,986 Patients Enrolled for Stroke

Media Library

Tenecteplase (Thrombolytic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT02398656 — Phase 3
Stroke Research Study Groups: Tenecteplase (tNK), Control (Antiplatelet Agents)
Stroke Clinical Trial 2023: Tenecteplase Highlights & Side Effects. Trial Name: NCT02398656 — Phase 3
Tenecteplase (Thrombolytic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02398656 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the potential dangers associated with Tenecteplase?

"Tenecteplase is considered safe based on its Phase 3 status, meaning that there is some data supporting efficacy and multiple rounds of data supporting safety."

Answered by AI

Are there other ongoing investigations using Tenecteplase?

"2007 saw the first study of tenecteplase at the Institute of cardiovascular diseases,Fuwai hospital. As of now, there have been a total of 386 completed trials. Right now, 71 studies are ongoing, with a considerable amount of research coming out of Kingston, Ontario."

Answered by AI

Where is this study being conducted?

"Along with 14 other locations, this clinical trial is currently accepting patients at Kingston General Hospital in Kingston, Ontario, Ottawa General Hospital in Ottawa, British Columbia, and Hamilton Health Sciences Centre in Hamilton, Quebec."

Answered by AI

What is the standard application of Tenecteplase?

"Tenecteplase is not only useful for prophylaxis against cardiovascular events, but also for treating other conditions such as unstable angina pectoris and acute chest syndrome."

Answered by AI

How many people can be in this clinical trial at one time?

"That is accurate. The clinical trial, which began recruitment on April 1st, 2015, is presently looking for 1274 patients from 14 different locations, as stated on clinicaltrials.gov."

Answered by AI
Recent research and studies
~88 spots leftby Dec 2024