TEMPO-2
Research type
Research Study
Full title
Multicentre, prospective randomized open label, blinded-endpoint (PROBE) controlled trial of thrombolysis with low dose Tenecteplase (TNK-tPA) versus standard of care in the prevention of disability at 3 months in minor ischemic stroke with proven acute symptomatic occlusion.
IRAS ID
209066
Contact name
Keith Muir
Contact email
Sponsor organisation
University of Calgary
Eudract number
2015-005469-22
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 21 days
Research summary
Summary of Research
Most minor strokes are due to lack of blood getting to a part of the brain. When this occurs, a person will experience a sudden loss of function in that region of the brain. This might mean inability to move a limb or inability to speak. In the luckiest case, these symptoms resolve rapidly by themselves because the body is able to break down the clot that causes the blockage, and we call it a transient ischemic attack (TIA). If less lucky, the disability persists and is called a stroke. Minor stroke and TIA probably account for slightly more than 50% of all strokes."Clot busting" (thrombolytic) drugs improve the likelihood of recovery by restoring blood flow to the brain, but carry a small risk of causing bleeding in the brain. Physicians are unsure whether this treatment should be used in people with minor stroke and TIA, and commonly do not treat people in this way.
Newer scanning methods show that those with a blocked blood vessel on a brain scan are at high risk of disability with conservative treatment, however, despite apparently "minor" symptoms. This group of patients may benefit from treatment with clot-busting drugs.
This study will test whether a clot-busting drug (tenecteplase, or TNK) improves the chances of recovery in people with minor ischemic stroke and a blocked blood vessel in the brain, compared to standard medical care (usually aspirin or similar medication). Patients will have a 50:50 chance (i.e. like the toss of a coin) of being allocated to tenecteplase or usual care. Patients will be assessed 3 months after the event for disability.
Summary of Results
Most minor strokes are due to lack of blood getting to a part of the brain. When this occurs, a person will experience a sudden loss of function in that region of the brain. If the symptoms persist and are relatively mild, it is called a minor stroke. Most minor stroke patients are not treated with clot busting drugs as the risk of bleeding from the drug is felt too high given the relatively minor deficits. We have shown previously that minor stroke patients with evidence of a blocked blood vessel on a brain scan are at a high risk of worsening with conservative treatment.In the TEMPO-2 clinical trial, we tested whether the clot busting drug TNK, given as a single dose, is better than usual care for patients with minor stroke with a proven blocked artery within the brain. Patients had a 50:50 chance of getting either TNK or usual care. Patients will be assessed 3 months after the event for evidence of disability.
We found that there was no benefit from TNK over standard of care. Patients with minor stroke and intracranial occlusion should be treated with drugs like aspirin and not clot busting medications.
REC name
Scotland A: Adults with Incapacity only
REC reference
17/SS/0105
Date of REC Opinion
22 Nov 2017
REC opinion
Further Information Favourable Opinion