Effect of an angiotensin receptor antagonist on cerebral blood flow, cerebral perfusion pressure, and systemic and peripheral haemodynamics in patients with acute stroke

ISRCTN	ISRCTN41456162
DOI	https://doi.org/10.1186/ISRCTN41456162
EudraCT/CTIS number	2006-005082-19
Secondary identifying numbers	1.1

Submission date: 07/07/2008
Registration date: 29/07/2008
Last edited: 04/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Gillian Sare
Scientific

Division of Stroke Medicine
Clinical Sciences Building
City Hospital
Nottingham
NG5 1PB
United Kingdom

Phone	+44 (0)115 8231769
Email	abc@123.com

Study information

Study design	Single centre, interventional, randomised, double blind placebo controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Effect of an angiotensin receptor antagonist on cerebral blood flow, cerebral perfusion pressure, and systemic and peripheral haemodynamics in patients with acute stroke
Study acronym	TAST
Study objectives	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.
Ethics approval(s)	Ethics approval received from the UK National Research Ethics Service - committee LNR1 on the 11th December 2006 (ref: 06/Q2501/228)
Health condition(s) or problem(s) studied	Hypertension in acute stroke
Intervention	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.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Telmisartan
Primary outcome measure	Quantitative cerebral blood flow (xenon computed tomography [CT] figure) before and 1.5 hours after first treatment.
Secondary outcome measures	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.
Overall study start date	01/07/2007
Completion date	30/11/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	34
Key inclusion criteria	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
Key exclusion criteria	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
Date of first enrolment	01/07/2007
Date of final enrolment	30/11/2009

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Division of Stroke Medicine

Nottingham
NG5 1PB
United Kingdom

Sponsor information

University of Nottingham (UK)
University/education

Research Innovation Department
University of Nottingham
Kings Meadow Campus
Nottingham
NG7 2NR
England
United Kingdom

Phone	+44 (0)115 9515792
Email	paul.cartledge@nottingham.ac.uk
Website	http://www.nottingham.ac.uk/
"ROR"	https://ror.org/01ee9ar58

Funders

Funder type

Charity

British Heart Foundation (BHF) (UK) (ref: PG/05/137/19999)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): the_bhf, The British Heart Foundation, BHF
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	05/06/2013		Yes	No

Editorial Notes

04/01/2019: The following changes have been made:
1. Publication reference added.
2. EudraCT number added.