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| ID | Type | Description | Link |
|---|---|---|---|
| TGA Trial Number: 1999/271 | |||
| Enterprise ID: 15314 |
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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
To determine whether the extent of the ischemic penumbra apparent on perfusion-diffusion MRI can be used to identify patients who would respond positively and safely to tissue plasminogen activator (tPA) beyond 3 hours post-stroke.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alteplase t-PA | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Hypothesis - lesion growth | ||
| In patients with penumbra, there will be attenuation of lesion growth (outcome T2 lesion volume - acute DWI volume ) with tPA. |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Hypotheses | ||
| In the non-penumbral group, lesion growth will be lower and will not be attenuated by tPA. | ||
| Favourable functional outcome (mRS 0-2) will be more likely in patients with penumbra receiving tPA. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen M Davis, MD FRCP FRACP | Melbourne Health | Study Chair |
| Geoffrey Donnan, MD FRACP | National Stroke Research Institute, Australia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunter New England Area Health Service | Newcastle | New South Wales | 2310 | Australia | ||
| Royal Brisbane Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23250996 | Derived | Ogata T, Christensen S, Nagakane Y, Ma H, Campbell BC, Churilov L, Lansberg MG, Straka M, De Silva DA, Mlynash M, Bammer R, Olivot JM, Desmond PM, Albers GW, Davis SM, Donnan GA; EPITHET and DEFUSE Investigators. The effects of alteplase 3 to 6 hours after stroke in the EPITHET-DEFUSE combined dataset: post hoc case-control study. Stroke. 2013 Jan;44(1):87-93. doi: 10.1161/STROKEAHA.112.668301. Epub 2012 Dec 18. | |
| 21474799 |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C067262 | PLAT protein, human |
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| That the proportion of patients achieving good neurological outcome (an 8 point improvement in NIH-SS or outcome NIH-SS of 0, 1) will be greater in those patients with a penumbra receiving tPA. |
| Symptomatic hemorrhagic transformation (sICH) will be predicted by the size of the baseline DWI volume in those patients receiving tPA. |
| Reperfusion (greater than 90% PWI lesion reduction, or recanalisation on MRA, between the acute and sub-acute interval), will be increased (in patients with penumbra) receiving tPA. |
| In patients with malignant mismatch (Definition DWI 100ml or more and / or PWI 100ml or more) there will be unfavourable clinical outcome (even if there is attenuation of growth). |
| Brisbane |
| Queensland |
| 4072 |
| Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Flinders Medical Center | Adelaide | South Australia | 5042 | Australia |
| Royal Melbourne Hospital | Melbourne | Victoria | 3050 | Australia |
| St Vincents Hospital | Melbourne | Victoria | 3065 | Australia |
| Austin Hospital | Melbourne | Victoria | 3081 | Australia |
| Box Hill Hospital | Melbourne | Victoria | 3128 | Australia |
| Alfred Hospital | Melbourne | Victoria | 3144 | Australia |
| Royal Perth Hospital | Perth | Western Australia | 6001 | Australia |
| Cliniques Universitaires St Luc | Brussels | B-1200 | Belgium |
| Auckland City Hospital | Auckland | 92024 | New Zealand |
| Christchurch Hospital | Christchurch | 4710 | New Zealand |
| Southern General Hospital | Glasgow | Scotland | United Kingdom |
| Derived |
| Mlynash M, Lansberg MG, De Silva DA, Lee J, Christensen S, Straka M, Campbell BC, Bammer R, Olivot JM, Desmond P, Donnan GA, Davis SM, Albers GW; DEFUSE-EPITHET Investigators. Refining the definition of the malignant profile: insights from the DEFUSE-EPITHET pooled data set. Stroke. 2011 May;42(5):1270-5. doi: 10.1161/STROKEAHA.110.601609. Epub 2011 Apr 7. |
| 18296121 | Derived | Davis SM, Donnan GA, Parsons MW, Levi C, Butcher KS, Peeters A, Barber PA, Bladin C, De Silva DA, Byrnes G, Chalk JB, Fink JN, Kimber TE, Schultz D, Hand PJ, Frayne J, Hankey G, Muir K, Gerraty R, Tress BM, Desmond PM; EPITHET investigators. Effects of alteplase beyond 3 h after stroke in the Echoplanar Imaging Thrombolytic Evaluation Trial (EPITHET): a placebo-controlled randomised trial. Lancet Neurol. 2008 Apr;7(4):299-309. doi: 10.1016/S1474-4422(08)70044-9. Epub 2008 Feb 28. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |