Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke

TARDIS (ISRCTN47823388)

The 'Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke' (TARDIS) trial is a collaborative, international, multicentre, prospective, randomised, blinded endpoint, parallel-group, controlled trial testing the safety and efficacy of one month of intensive antiplatelet therapy (combined aspirin, clopidogrel and dipyridamole) in comparison with guideline antiplatelet therapy (aspirin and dipyridamole) in patients with acute ischaemic stroke or TIA

3,500+ patients with acute ischaemic stroke or high risk TIA are enrolled within 48 hours of onset. The primary outcome is the frequency and severity of recurrent cerebrovascular events determined at 90 days by observers blinded to treatment. The BHF-funded start-up phase is testing the safety, feasibility and tolerability of the trial and interventions.

If you are interested in having your centre join the trial, please fill in an Expression of Interest form and send/fax to the Coordinating Centre as per details at bottom of form.

UK National Research Ethics Sevice (NRES) research summary of the trial

2012, May: Trial reaches 750 patients - congratulations to all recruiting investigators. Independent Data Monitoring Committee clear trial to continue as is.

TARDIS trial website and database

Enter LIVE TARDIS trial web-site

Status

As of 9 May 2012 (see logon page for latest numbers):

Enrolled patients: 750 - ischaemic stroke 457 (61%), TIA 293 (39%)

Centres who have recruited: 56 (in UK)

Funding

British Heart Foundation
The Stroke Association (through The Division of Stroke, University of Nottingham)

Forthcoming events

TARDIS will be attending:

May 2012: European Stroke Conference, Lisbon, Portugal

News

March 2012: Congratulations to all recruiting sites and investigators - TARDIS reaches 700 participants
November 2011: Congratulations to all recruiting sites and investigators - TARDIS reaches 600 participants
October 2011: Congratulations to all recruiting sites and investigators - TARDIS reaches 550 participants
August 2011: Congratulations to all recruiting sites and investigators - TARDIS reaches 500 participants, 150 more than its original BHF-funded target
July 2011: Grant application submitted to HTA for main phase of trial
June 2011: Data Monitoring Committee recommend that TARDIS should continue without modification
March 2011: British Heart Foundation agree to expand funding to allow more patients to be enrolled beyond the 350 participants originally agreed
March 2011: Congratulations to all active centres - TARDIS reaches 350 participants, its original funding target, but reached a year early!!
December 2010: Congratulations to all investigators - TARDIS reaches 300 participants
December 2010: Trial Steering Committee met
September 2010: Congratulations to all investigators - TARDIS reaches 200 participants
July 2010: Welcome to Drs Ahamad Hassan and William Toff who have joined the Trial Steering Committee as Independent Expert members
June 2010: Data Monitoring Committee recommend, at their first meeting, that TARDIS should continue without modification
November 2009: Scottish SRN Investigator meeting, Glasgow, UK
September 2009: Three centres now enrolling
April 2009: First patient enrolled into trial, at Nottingham, UK
March 2009: UK Investigator meeting, Nottingham, UK
August 2008: Start-up phase of TARDIS trial funded by BHF

TARDIS in the News

TARDIS trial seeks new dimension in stroke treatment Medical Xpress, 17 Oct 2011
TARDIS trial seeks new dimension in stroke treatment HealthCanal, 17 Oct 2011
TARDIS trial seeks new dimension in stroke treatment University of Nottingham, 17 Oct 2011
Triple cocktail to tackle stroke risk Physorg.com, 17 Sept 2008

Documents

Newsletter 8 - January 2012 (PDF file)

Newsletter 7 - October 2011 (PDF file)

Newsletter 6 - August 2011 (PDF file)

Newsletter 5 - April 2011 (PDF file)

Newsletter 4 - December 2010 (PDF file)

Newsletter 3 - August 2010 (PDF file)

Newsletter 2 - April 2010 (PDF file)

Newsletter 1 - December 2009 (PDF file)

Presentations/publications/listings/media

February 2012: International Stroke Conference/American Stroke Association, New Orleans, USA
November 2011: UK Stroke Forum, Glasgow, UK
September 2011: 16th Nordic Congress on Cerebrovascular Disease, Tallinn, Estonia
May 2011: European Stroke Conference XX, Hamburg, Germany
February 2011: American Stroke Association / International Stroke Conference, Los Angeles, USA
December 2010: UK Stroke Forum, Glasgow, UK
November 2010: Scottish Stroke Research Network, Glasgow, UK
September 2010: North West Stroke Research Network, Manchester, UK
June 2010: NIHR SRN Annual Conference, Newcastle, UK
May 2010: European Stroke Conference, Barcelona, Spain
February 2010: International Stroke Conference/American Stroke Association, San Antonio, USA
December 2009: UK Stroke Forum, Glasgow, UK
November 2009: Scottish Stroke Research Network Investigator Meeting, Glasgow, UK
July 2009: UK Stroke Research Network Annual Conference, Newcastle, UK
May 2009: Peninsula Stroke Research Network Annual Conference, Exeter, UK
March 2009: UK Investigator meeting, Nottingham, UK
February 2009: International Stroke Conference, San Diego, US
December 2008: UK Stroke Forum, Harrogate, UK

Demo/practice website and database

Enter DEMO TARDIS demonstration/practice trial web-site

Study personnel

Trial Steering Committee:

Helen Rodgers (Newcastle, Independent Chair), Philip Bath (Nottingham, Chief Investigator), Ahamad Hassan (Leeds, Independent Expert), Stan Heptinstall (Nottingham), Hugh Markus (London), Ossie Newell (Nottingham, Participant representative), Tom Robinson (Leicester), Graham Venables (Sheffield), Angela Shone (University of Nottingham/sponsor representative), William Toff (Leicester, Independent Expert)

Trial Management Committee (Nottingham):

Philip Bath (Chair), Margaret Adrian (Trial Coordinator), Diane Havard (Trial Coordinator, P/T), Patrick Cox (Nurse Coordinator), Sandeep Ankolekar (Medic), Cheryl Hogg (Statistician), Wim Clarke (Financial), Valerie Chandrakumar (Secretary)

Independent Data Monitoring Committee:

Ian Ford (Glasgow, Chair), Cathie Sudlow (Edinburgh), Matthew Walters (Glasgow), Cheryl Hogg (Statistician, Nottingham)

Independent Events (outcome, SAE) Adjudicator:

Niki Sprigg (Nottingham)

Neuroimaging Adjudicator:

Rob Dineen

Transcranial doppler substudy:

Hugh Markus, Alice King (London)

Platelet substudy:

Stan Heptinstall, Sue Fox, Jane May (Nottingham)

Programming/database management:

Lee Haywood, Liz Walker (UK)

Contact details

TARDIS Trial Office

Division of Stroke Medicine

Institute of Neuroscience

University of Nottingham

Clinical Sciences Building

City Hospital campus

Hucknall Road

Nottingham NG5 1PB

Telephone: +44 115 823 0210

Fax: +44 115 823 0273

E-mail: tardis@nottingham.ac.uk

Written by Philip Bath, last updated 9 May 2012