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ISRCTN
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ISRCTN41456162
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ClinicalTrials.gov identifier
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Public title
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Effect of an angiotensin receptor antagonist on cerebral blood flow, cerebral perfusion pressure, and systemic and peripheral haemodynamics in patients with acute stroke
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Scientific title
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Acronym
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TAST
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Serial number at source
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1.1
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Study hypothesis
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The hypothesis is that it is possible to lower blood pressure in hypertensive patients with acute stroke using telmisartan (an angiotensin receptor antangonist) without reducing cerebral blood flow.
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Lay summary
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Ethics approval
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Ethics approval received from the UK National Research Ethics Service - committee LNR1 on the 11th December 2006 (ref: 06/Q2501/228)
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Study design
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Single centre, interventional, randomised, double blind placebo controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Hypertension in acute stroke
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Participants - inclusion criteria
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1. Patients must have suffered ischaemic or haemorrhagic stroke
2. Patients must be 18 years of age or over, either sex
3. Onset date of stroke is less than 5 days
4. Systolic blood pressure (BP) greater than 140 mmHg
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Participants - exclusion criteria
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1. Less than 18 years of age
2. Normotension or hypotension (systolic BP less than 140 mmHg)
3. Onset date more than 5 days
4. Coma (Scandinavian Stroke Scale [SSS] less than 4)
5. Patients who are of childbearing potential, pregnant or breastfeeding
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Anticipated start date
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01/07/2007
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Anticipated end date
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30/11/2009
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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34
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Interventions
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Telmisartan 80 mg once a day or matched placebo. The patients are in the trial for 90 days, and receive treatment for the whole period.
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Primary outcome measure(s)
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Quantitative cerebral blood flow (xenon computed tomography [CT] figure) before and 1.5 hours after first treatment.
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Secondary outcome measure(s)
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1. Middle cerebral artery blood flow velocity (MCABFV) and pulsatility index (transcranial doppler [TCD])
2. Central blood pressure
3. Augmentation index (AI [applanation tonometry at carotid and radial arteries on ipsilateral side, SphygmoCor])
4. Peripheral blood pressure
5. Heart rate (Omron)
Measured at baseline, and 4.5 hours after first dose, day 4, 7 and 90 treatment.
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Sources of funding
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British Heart Foundation (BHF) (UK) (ref: PG/05/137/19999)
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Trial website
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Publications
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Contact name
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Dr
Gillian
Sare
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Address
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Division of Stroke Medicine
Clinical Sciences Building
City Hospital
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City/town
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Nottingham
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Zip/Postcode
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NG5 1PB
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Country
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United Kingdom
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Tel
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+44 (0)115 8231769
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Fax
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+44 (0)115 8231771
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Email
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mszgs@exmail.nottingham.ac.uk
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Sponsor
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University of Nottingham (UK)
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Address
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Research Innovation Department
University of Nottingham
Kings Meadow Campus
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City/town
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Nottingham
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Zip/Postcode
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NG7 2NR
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Country
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United Kingdom
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Tel
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+44 (0)115 9515792
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Fax
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+44 (0)115 9515796
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Email
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paul.cartledge@nottingham.ac.uk
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Sponsor website:
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http://www.nottingham.ac.uk/
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Date applied
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07/07/2008
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Last edited
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29/09/2008
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Date ISRCTN assigned
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29/07/2008
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