Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis- (ATTEST) (ATTEST)
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|ClinicalTrials.gov Identifier: NCT01472926|
Recruitment Status : Unknown
Verified August 2012 by Keith Muir, NHS Greater Glasgow and Clyde.
Recruitment status was: Recruiting
First Posted : November 17, 2011
Last Update Posted : August 10, 2012
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Drug: Tenecteplase Drug: alteplase||Phase 2|
Newer thrombolytic agents such as tenecteplase have pharmacological features (higher fibrin binding specificity and longer half-life) that may be advantageous when compared to older agents such as alteplase with respect to arterial recanalisation, ease of administration, and reduced bleeding risk. No other clinical trial is currently evaluating alternative thrombolytic strategies in patients who are eligible to receive standard intravenous alteplase, instead concentrating on extending the population for IV thrombolysis.
The ATTEST pilot phase will use brain imaging as a biomarker for key clinical response variables, with penumbral salvage as the primary end-point and secondary end-points including recanalisation as well as conventional clinical scales.
The findings of this study are anticipated to provide data on sample size and event rates to inform the design of a definitive, confirmatory, pragmatic, randomised, controlled trial with clinical endpoints.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||104 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis - Pilot Phase (ATTEST)|
|Study Start Date :||December 2011|
|Estimated Primary Completion Date :||September 2013|
|Estimated Study Completion Date :||January 2014|
Experimental: Tenecteplase 0.25 mg/kg
Intravenous tenecteplase 0.25 mg/kg (single bolus, maximum 25 mg)
Intravenous (IV) tenecteplase 0.25 mg/kg (single bolus; maximum dose 25 mg)
Active Comparator: Alteplase 0.9 mg/kg
Intravenous alteplase 0.9 mg/kg (10% bolus and 90% as IV infusion over 1 hour, maximum 90 mg)
Intravenous alteplase 0.9mg/kg to maximum of 90mg, given as 10% bolus and 90% of dose over 1 hour infusion
- Percent penumbral salvage at 24-48h (initial penumbra volume on computed tomography perfusion (CTP) imaging versus 24-48h CT infarct volume. [ Time Frame: 48 hours ]Percent penumbral salvage at 24-48h (initial CTP-defined penumbra volume versus 24-48h CT infarct volume.
- Proportion of patients exhibiting recanalisation (on computed tomography angiography, CTA) 24-48 hours post treatment [ Time Frame: 48 hours ]Proportion of patients exhibiting recanalisation (measured by CTA) 24-48 hours post treatment
- Early clinical improvement 24 hours post treatment [ Time Frame: 24 hours ]Early clinical improvement (National Institutes of Health Stroke Scale [NIHSS] score reduced by >=4 points, or = 0 or 1) 24 hours post treatment
- Proportion of patients with symptomatic intracerebral haemorrhage (SICH) on 24-48 hour CT [ Time Frame: 48 hours ]
Proportion of patients with symptomatic ICH (SICH) on 24-48 hour CT:
- by Safe Implementation of Thrombolysis Monitoring Study (SITS-MOST) definition - parenchymal haematoma type 2 (PH2/PHr2) + NIHSS deterioration by >=4 points at 24 hours
- Any ICH
- Distribution of functional outcome by modified Rankin Scale (mRS) scores at Day 30 [ Time Frame: 30 Days ]Distribution of outcome scores on the modified Rankin Scale (mRS)
- Distribution of functional outcome scores (mRS) at Day 90 [ Time Frame: 90 days ]Distribution of functional outcome scores (mRS)
- Proportion of patients with favourable clinical outcome (mRS 0-1) at Day 30 [ Time Frame: 30 days ]Proportion of patients with favourable clinical outcome (mRS 0-1)
- Proportion of patients with favourable clinical outcome (mRS 0-1) at Day 90 [ Time Frame: 90 days ]Proportion of patients with favourable clinical outcome (mRS 0-1)
- Average 'home time' by day 90 [ Time Frame: 90 Days ]Average 'home time' (number of nights spent in non-institutional private residence) by Day 90
- Mortality at Day 90 [ Time Frame: 90 Days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01472926
|Contact: Keith Muir||+44 141 201 email@example.com|
|Southern General Hospital||Recruiting|
|Glasgow, Scotland, United Kingdom, G51 4TF|
|Principal Investigator: Keith Muir|
|Study Chair:||Keith Muir||The University of Glasgow|