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

4,100+ 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 tested the safety, feasibility and tolerability of the trial and interventions. The main phase of the trial is funded by the HTA.

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.

Trial synopsis, V1.0 (pdf)

2016, April: TARDIS is now closed to recruitment. Please would Investigators continue to follow-up all patients as per the protocol, and speedily address requests from the Coordinating Centre for data validation and correction. The final results based on cleaned and locked data will be presented and published, hopefully before end of 2016; until then they will be confidential (as with other large trials). Please follow national stroke guidelines for all treatment decisions. Many thanks for taking part in this important study.

TARDIS trial website and database

Enter LIVE TARDIS trial web-site

Status

As of close of recruitment (13th April 2016):

Enrolled patients: 3096 - ischaemic stroke 2148 (69.4%), TIA 948 (30.6%)
Guideline split in stroke: Clopidogrel 58.8%, aspirin/dipyridamole 41.2%
Guideline split in TIA: Clopidogrel 46.8%, aspirin/dipyridamole 53.2%
Centres in the UK: 124
Centres in Europe: 6
Centres in Oceania: 1
Total centres: 131

Tweets by @tardistrial

Funding

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

Forthcoming events

TARDIS will be attending:

News

April 2016: TARDIS is now closed to recruitment. Please would Investigators continue to follow-up all patients as per the protocol, and speedily address requests from the Coordinating Centre for data validation and correction. The final results based on cleaned and locked data will be presented and published, hopefully before end of 2016; until then they will be confidential (as with other large trials). Please follow national stroke guidelines for all treatment decisions. Many thanks for taking part in this important study.
March 2016: Data Monitoring Committee recommend that TARDIS is paused temporarily
September 2014: Data Monitoring Committee recommend that TARDIS continues without modification
January 2015: Data Monitoring Committee recommend that TARDIS continues without modification
September 2014: Data Monitoring Committee recommend that TARDIS continues without modification
September 2014: Congratulations to all recruiting sites and investigators: we have reached the half-way point in recruitment! Well done to Royal Preston Hospital, UK, for recruiting the 2,050th participant
August 2014: Congratulations to all recruiting sites and investigators: we have reached our 2000th participant!
March 2014: Data Monitoring Committee recommend that TARDIS continues without modification
February 2014: TARDIS is highlighted by NIHR as part of its 'Focus on Stroke' initiative
October 2013: TARDIS reaches 1/3 of its participant target - congratulations everyone!
May 2013: Data Monitoring Committee recommend that TARDIS should continue without modification
January 2013: TARDIS reaches 1000 participants: congratulations to all recruiting sites and investigators!
November 2012: Data Monitoring Committee recommend that TARDIS should continue without modification
October 2012: HTA funded main phase of trial commences with recruitment target of 4,100. The trial expand internationally.
July 2012: Fantastic news - HTA fund main phase of trial. This will commence in October and involve international sites from around the world
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: Triple Antiplatelet Therapy No Benefit in Stroke, TIA Medscape Neurology, 24 Feb 2017
Safety and efficacy of Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke: the TARDIS randomised controlled trial NIHR Journal Library, 26 Jan 2017
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

The Virtual Medical Centre has produced some videos with Lesley Cala, scan adjudicator on TARDIS, which involve TARDIS:
'Improving Stroke Outcomes' (link), 10/09/2015
For the following video you will need to sign up here: this is free but only registered health professionals (who input the required registration numbers) will be able to view this video.
TARDIS, TICH and TICH-2 trials (link), 11/09/2015.

Newsletters

Newsletter 23 - July 2017 (pdf)
Newsletter 22 - May 2017 (pdf)
Newsletter 21 - September 2016 (pdf)
Newsletter 20 - August 2016 (pdf)
Newsletter 19 - May 2016 (pdf)
Newsletter 18 - March 2016 (pdf)
Newsletter 17 - September 2015 (pdf)
Newsletter 16 - May 2015 (pdf)
Newsletter 15 - September 2014 (pdf)
Newsletter 14 - July 2014 (pdf)
Newsletter 13 - January 2014 (pdf)
Newsletter 12 - November 2013 (pdf)
Newsletter 11 - July 2013 (pdf)
Newsletter 10 - March 2013 (pdf)
Newsletter 9 - July 2012 (pdf)
Newsletter 8 - January 2012 (pdf)
Newsletter 7 - October 2011 (pdf)
Newsletter 6 - August 2011 (pdf)
Newsletter 5 - April 2011 (pdf)
Newsletter 4 - December 2010 (pdf)
Newsletter 3 - August 2010 (pdf)
Newsletter 2 - April 2010 (pdf)
Newsletter 1 - December 2009 (pdf)

Presentations/publications/listings/media

May 2017: European Stroke Organisation Conference, Prague, Czech Republic
February 2017: International Stroke Conference, Houston, TX, USA
November 2016: UKSF, Liverpool, UK
May 2016: ESOC, Barcelona, Spain
December 2015: UK Stroke Forum, Liverpool, UK
August 2015: Nordic Stroke Congress, Malmö, Sweden
May 2015: NIMAST, Belfast, UK
April 2015: ESO, Glasgow, UK
February 2015: ISC, Nashville, USA
December 2014: UK Stroke Forum, Harrogate, UK
October 2014: World Stroke Congress, Istanbul, Turkey
June 2014: Welsh Stroke Conference, Cardiff, UK
May 2014: European Stroke Conference, Nice, France
May 2014: NIMAST, Belfast, Ireland
February 2014: ISC, San Diego, USA
December 2013: UK Stroke Forum, Harrogate
October 2013: World Stroke Day, Wigan, UK
August 2013: Nordic Stroke Conference, Vilnius, Lithuania
May 2013: European Stroke Conference, London, UK
February 2013: International Stroke Conference/American Stroke Association, Honolulu, USA
December 2012: UK Stroke Forum, Harrogate, UK
October 2012: World Stroke Congress, Brasilia, Portugal
May 2012: European Stroke Conference, Lisbon, Portugal
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:

Independent experts: Helen Rodgers (Newcastle, TSC Chair/Stroke Physician), Ahamad Hassan (Leeds, Neurologist), Christine Roffe (Stoke-on-Trent, Stroke Physician), Craig Smith (Salford, Stroke Physician), William Toff (Leicester, Trialist)
Grant holders: Philip Bath (Nottingham, Chief Investigator/Stroke Physician), Rob Dineen (Nottingham, Neuroradiologist), Lelia Duley (Nottingham, Trialist), Stan Heptinstall (Nottingham, Platelets), Marilyn James (Nottingham, Health Economics), Hugh Markus (Cambridge, Neurologist), Stuart Pocock (London, Biostatistician), Tom Robinson (Leicester, Stroke Physician), Niki Sprigg (Nottingham, Co-Chief Investigator), Graham Venables (Sheffield, Neurologist)
Patient representative: Chibeka Kasonde (Nottingham)
Sponsor's representative: Angela Shone (University of Nottingham)

Former Members:
Ossie Newell (Patient representative, Nottingham)

International Advisory Committee:
Denmark - Hanne Christensen, Georgia - Maia Beridze, New Zealand - Anna Ranta

Trial Management Committee (Nottingham):
Philip Bath (Chair), Diane Havard (Trial Manager), Margaret Adrian (UK Trial Coordinator), Michael Stringer (UK Trial Coordinator), Jamie Longmate (UK Trial Coordinator), Jason Appleton (Medic), Lisa Woodhouse (Statistician), Mark Sampson (Data and Imaging), Wim Clarke (Financial), Yvonne Smallwood (Secretary)

Former Members:
Sally Utton (Trial Manager), Hayley Foster (Trial Manager), Harriet Howard (UK Trial Coordinator), Tanya Payne (UK Trial Coordinator), Alice Durham (International Trial Coordinator), Joanne Keeling (International Trial Coordinator; Outcome Coordinator), Sharon Ellender (International Trial Coordinator; Outcome Coordinator), Sarah Grant (International Trial Coordinator; Outcome Coordinator), James Kirby (International Trial Coordinator; Outcome Coordinator), Lynsey Cobane (Outcome Coordinator), Jennifer Smithson (Outcome Coordinator), Gemma Walker (Outcome Coordinator), Kailash Krishnan (Medic), Cheryl Hogg (Statistician), Aimee Houlton (Statistician), Katie Flaherty (Statistician), Dawn Hazle (Data and Imaging), Tanya Jones (Data and Imaging), Lauren Dunn (Secretary)

Independent Data Monitoring Committee:
Ian Ford (Glasgow, Chair), Didier Leys (Lille, Belgium), Cathie Sudlow (Edinburgh), Matthew Walters (Glasgow)

Outcome & SAE Adjudicators:
Nikola Sprigg (Nottingham), Marc Randall (Leeds), Kailash Krishnan (Nottingham), Wayne Sunman (Nottingham)

Neuroimaging Adjudicators:
Rob Dineen (Nottingham), Alessandro Adami (Verona, Italy), Lesley Cala (Perth, Australia), Ana Casado (Edinburgh), Rebecca Gallagher (Nottingham), David Sweinton (Nottingham)

Platelet substudy:
Stan Heptinstall, Sue Fox, Jane May (Nottingham)

Other members:
Richard Donnelly (Vascular Medicine, Derby), Alan Montgomery (Statistician, Nottingham)

Programming/database management:
Richard Dooley, Liz Walker (UK)
Formerly: Lee Haywood (UK), Graham Watson (UK)

Contact details

TARDIS Trial Office

Stroke, Division of Clinical Neuroscience

University of Nottingham

Clinical Sciences Building

City Hospital Campus

Hucknall Road

Nottingham

NG5 1PB

Telephone: +44 115 823 1770

Fax: +44 115 823 1771

E-mail: tardis@nottingham.ac.uk

Written by Philip Bath, last updated by Mark Sampson 13 September 2017