Condition category
Circulatory System
Date applied
07/07/2008
Date assigned
29/07/2008
Last edited
21/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gillian Sare

ORCID ID

Contact details

Division of Stroke Medicine
Clinical Sciences Building
City Hospital
Nottingham
NG5 1PB
United Kingdom
+44 (0)115 8231769

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.1

Study information

Scientific title

Acronym

TAST

Study hypothesis

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

Ethics approval received from the UK National Research Ethics Service - committee LNR1 on the 11th December 2006 (ref: 06/Q2501/228)

Study design

Single centre, interventional, randomised, double blind placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Telmisartan

Primary outcome measures

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 trial start date

01/07/2007

Overall trial end date

30/11/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

34

Participant 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

Recruitment start date

01/07/2007

Recruitment end date

30/11/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Division of Stroke Medicine
Nottingham
NG5 1PB
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

Research Innovation Department
University of Nottingham
Kings Meadow Campus
Nottingham
NG7 2NR
United Kingdom
+44 (0)115 9515792
paul.cartledge@nottingham.ac.uk

Sponsor type

University/education

Website

http://www.nottingham.ac.uk/

Funders

Funder type

Charity

Funder name

British Heart Foundation (BHF) (UK) (ref: PG/05/137/19999)

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes