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Tenecteplase for Ischemic Stroke (TEMPO-2 Trial)
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.
TEMPO-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTEMPO-2 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2008 Phase 3 trial • 223 Patients • NCT00396253TEMPO-2 Trial Design
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Who is running the clinical trial?
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- I was independent in daily activities before my stroke.My illness is severe and treatment is unlikely to help.I am scheduled for a clot-dissolving treatment.I haven't had serious bleeding issues in the last 3 months.I started treatment within 12 hours of my symptoms appearing.I had a minor stroke or TIA with little to no lasting effects.Your medical history, previous scans, or doctor's opinion indicate a long-standing blockage in the brain.You had a stroke while in the hospital, unless you were already at your normal health before the stroke happened. For example, if you had a stroke during a test called a diagnostic coronary angiogram.I haven't had a stroke or serious head/spine injury in the last 3 months.I haven't had major surgery in the last 3 months that could cause serious bleeding.My platelet count is below 100,000.Taking dual antiplatelet therapy doesn't disqualify me from joining.I've had a recent arterial puncture in a spot that can't be easily compressed.I am on blood thinners but meet the specific conditions for a break or dosage.I have had a serious brain bleed in the past.I have a recent blockage in my brain's blood vessels that matches my symptoms.You have signs of bleeding in your brain on a type of scan called NCCT.You had a large acute stroke, and the CT scan showed a score less than 7.I have recently been treated with GP2b3a inhibitors.I can receive treatment within 90 minutes after my first CT or MRI scan.I am an adult who has had a stroke caused by a blood clot.You have a large area of damage in your brain from a stroke that happened more than 12 hours ago.
- Group 1: Tenecteplase (tNK)
- Group 2: Control (Antiplatelet Agents)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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