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*** APRIL UPDATE ***
APRIL 2006
Page
VITATOPS Update 1
Welcomes & Farewells 2
Misdiagnoses of Stroke/TIA 2
Extension of Trial/Follow-up 3
15th ESC & Investigator Meet- 3
Book Prize 3
Interim Analysis Update 3
Website Update 4
Collection of Vitamin B12 4
Depression & Dementia 4
Date Reporting 5
New Fax for Pharmacy 5
Medical University of Graz 5
Trial Office Contact Details 5
Active Sites 6-10
Prospective Sites 11
Drug Resupply Form 12
CONTENTS Welcome to the FIRST edition of the VITATOPS newsletter for 2006. Since July 2005 new sites in India and the UK have joined the study resulting in a significant increase in monthly recruitment totals. We welcome the following sites in India: Amrita Institute of Medical Science, Cochin; Poona Hospital, Pune and Ruby Hall Clinic. Number of Active Sites Participating: 94 Number of Countries Participating: 20 Number of Continents Participating: 5 Total Recruitment in NOV 2005: 98 Total Recruitment in DEC 2005: 108 Total Recruitment in JAN 2006: 124 Total Recruitment in FEB 2006: 94 Total Recruitment in MAR 2006: 64
Total Recruitment (31st March 2006): 5,728 Special CONGRATULATIONS to the top 3 re-cruiting sites in March; • SP Medical College, Bikaner: 10 patients • Singapore General Hospital: 6 patients • Care Hospital, Hyderabad: 6 patients
VITATOPS NEWSLETTER
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WELCOMES We welcome the following collaborators to the study and hope they enjoy participating on VITATOPS; Ana Dias – Hospital Do Visconde de Salreu Tessa Hammond – William Harvey Hospital Niels Kamerling – Algemeen Ziekenhuis Sint-Jan Autonome Versorginginstelling John Jones – University Hospital Aintree Nicola Sprigg – Nottingham City Hospital Venugopal Thattolicanhiratan – St Luke’s Hospital Daniel Vallini – South Carolina VA Hospital Martine Wilkinson – St Luke’s Hospital
FAREWELLS We farewell and thank the following collaborators for their contribution to the VITA-TOPS study and wish them all the best in the future; Katie Burlace – William Harvey Hospital Kevin Channell – University Hospital Aintree Eileen Conkie – Western Infirmary Shiraz Haider – St Luke’s Hospital Sabine Schindler – Medical University of Graz Mark Willmont – Nottingham City Hospital Nelson Wong – Singapore General Hospital
TRIAL OFFICE STAFF UPDATE We would like to thank Swee-Chin Bono for her collaboration on the VITATOPS study. We congratulate Swee-Chin on her new appointment as a full-time Pharmacy Assistant at the Royal Perth Hopsital Pharmacy Department.. Bianca Swarts is the new Phar-macy Technician for the VITATOPS Trial. Bianca can be contacted via e-mail on:
WELCOMES & FAREWELLS
MISDIAGNOSES OF STROKE/TIA
At a recent VITATOPS Steering Committee meeting the follow-up of patients recruited to the study with stroke/TIA, and who are later found to have been misdiagnosed, was dis-cussed. It was decided that these patients are no longer required to be followed-up.
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EXTENSION OF TRIAL & FOLLOW-UP BEYOND 5 YRS
There are now over 5,700 patients ran-domised to the trial. As we are still aim-ing to recruit 8,000 patients, the Steering Committee has recommended for ran-domisation to continue until at least mid 2007 and for follow up to continue until at least mid 2008. As each local Ethics Committee (EC) requirements differ the Trial Office recommends for collaborating sites to consult with their ECs (and Phar-macy Department if required) regarding extension for randomisation and follow-up beyond 5yrs. If patients agree to continue follow-up be-yond 5 yrs and new follow-up forms are required please contact the Trial Office. These forms can also be downloaded from the VITATOPS website.
INTERIM ANALYSIS UPDATE
An interim analysis was recently con-ducted in December 2005. At this time there were approximately 10,000 patient years of follow-up. The Data Safety Monitoring Committee concluded re-cruitment and follow-up SHOULD con-tinue.
BOOK PRIZE
Collaborating sites will have the opportunity to win Graeme Hankey’s recently published book “Stroke Treatment and Prevention: An Evidence-Based Approach”. Sites can win this prize in one of two ways; A book will be awarded to the site that ran-domises the 6,000th patient to the VITA-TOPS study. There are just over 270 pa-tients that remain to be recruited before this milestone is reached. Another prize will go to a site that completes and returns all data clarifications and out-standing follow-ups, as recently sent by Data Manager Corrie Cockayne. Eligible sites will be entered into a draw and the winning site will be notified via e-mail.
15th EUROPEAN STROKE CONFERENCE (ESC), BRUSSELS 16-19 MAY 2006
A meeting of VITATOPS Study Investiga-tors has been planned for the 15th ESC. The meeting will be held in conjunction with the CLOTS and ENOS trials. Please see below for meeting details; Date: Thursday, 18th May, 2006 Time: 12.30-14.00 Venue: Room 1125, Congress Building Dr Gabriel de Freitas (National Coordina-tor, Brazil) will be presenting this meet-ing on behalf of Graeme Hankey. Could you please notify the Trial Office if you and your colleagues will be able to attend the meeting. Furthermore, if you would like to include any items to the meeting agenda or request data for analysis please notify the Trial Office. Further details will be confirmed in an e-mail to collaborators shortly.
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WEBSITE UPDATE
You will now be prompted to enter your name when randomising patients via the VI-TATOPS on-line randomisation service. The website has also been modified to ensure that only patients who have suffered their randomising stroke/TIA within 7 months of recruitment to the study are successfully al-located a VITATOPS study number. If the patient had their randomising stroke more than 7 months prior to recruitment an error message will be displayed notifying you that the exclusion criteria has not been met.
COLLECTION OF VITAMIN B12 AT ENROLMENT
At a recent VITATOPS Steering Com-mittee meeting the collection of vitamin B12 at time of enrolment was discussed. The Steering Committee encourages sites to collect and record vitamin B12 levels at enrolment if available as part of routine testing. A field to report the patients B12 level is now included on the baseline case report forms. Modi-fied baseline forms are available via the VITATOPS website. If a patient’s vita-min B12 level at enrolment can be re-ported retrospectively please forward these results to the Trial Office.
DEPRESSION & DEMENTIA
A decision has been made by the Steering Committee to record depression and de-mentia as secondary outcome events on the blue major event (ME) forms. The ME forms have been modified to include these events as secondary outcomes. New ver-sions of the ME forms are available via the VITATOPS website. If you require hard copies to be posted to your site please contact the Trial Office.
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THE NEW FAX NUMBER TO
REQUEST TABLET STOCK IS
+61 8 9224 3696.
If tablet resupply is required
please provide at least 2
weeks notice to the VITATOPS
Pharmacy Dept to allow for
your request to be organised
and dispatched.
Please note, the former
site Karl-Franzens
University Graz is now
named MEDICAL
UNIVERSITY OF GRAZ.
DATE REPORTING
When reporting dates of birth or dates of events please adhere to the following guide-lines; 1. When the year is known but the day/ month is unknown please report 30/06/ year. 2. When the year and month is known but the day is unknown please report 15/month/year. 3. When the day/month/year is unknown please ask the patient to estimate the year by associating the date to an event in their life, eg. historical event, starting school).
TRIAL OFFICE CONTACT DETAILS
VITATOPS TRIAL OFFICE STROKE UNIT RESEARCH ROYAL PERTH HOSPITAL PO BOX X2213, PERTH WESTERN AUSTRALIA 6847
Phone: +61 8 9224 7004 (Julia Pizzi) Phone: +61 8 9224 3336 (Michelle Tang) Phone: +61 8 9224 8497 Fax: +61 8 9224 8424 Email: [email protected]
PAGE 6 ACTIVE RECRUITMENT (CURRENT TO 31 March, 2006)
Site Principal Investigator Research Coordinator Total AUSTRALIA
Alfred Hospital, VIC Judy Frayne Joanne Ferguson 42 Bankstown, NSW Jim Kokkinos Cathy Smith 36 Beleura & Frankston, VIC Prakash Nayagam Penny Clayton 25 Box Hill Hospital, VIC Chris Bladin Kelly Coughlan 40 Central Coast, Gosford, NSW Dennis Crimmins Michelle Rose
Alison Slattery 102
Flinders & Griffith, SA David Schultz Sara Laubscher 53 Fremantle, WA Tim Davies Valentina Rakic 59 Greenslopes, QLD Carolyn de Wytt Patricia Wall 12 John Hunter, NSW Chris Levi
Mark Parsons Elizabeth Pepper
Michelle Russell 26
Joondalup, WA Jake Harper Pam Rees Denise Warden
29
Liverpool, NSW Alan McDougall Lorraine Ryan 4 Nambour, QLD Rohan Grimley 2 Royal Hobart Hospital, TAS David Dunbabin Julie Sansom 30 Royal Perth Hospital, WA Graeme Hankey Katherine Loh 469 Sir Charles Gairdner, WA Keith Grainger 16
AUSTRIA
**Medical University of Graz Reinhold Schmidt Franz Fazekas Anita Lechner Barbara Ebenbauer Silvia Legat-Wallner Gerald Pichler Birgit Reinhart Thomas Seifert Mirja Waller Sabine Weiss
173
BELGIUM
**AZ Sint-Jan AV Geert Vanhooren Niels Kamerling Valérie Schotte
52
BRAZIL **Universidade Federal Fluminense & Universidade Federal do Rio de Ja-neiro
Gabriel de Freitas Charles André
Silvio EG Gomes Lidia Conforto Miguel Picanco Simone do Valle
71
HONG KONG
**Prince of Wales Hospital Lawrence Wong Adrian Wong Roxanna Liu
83
**Queen Mary Hospital Raymond Cheung Liza Hui 18
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ACTIVE RECRUITMENT (CURRENT TO 31 March, 2006)
Site Principal Investigator Research Coordinator Total INDIA
Amrita Institute of Medical Sciences Suresh Kumar Vinayan K.P
9
Baby Memorial Hospital, Calicut Abdul Salam Ummer Karadan
Jayanth K. Savanth Laila Achambat Reena Mathew
59
Care Hospital, Hyderabad JMK Murthy 51 Care Hospital, Visakhapatnam Kishore Babu 18 Christian Medical College, Ludhiana Yashpal Singh
T.M. Jaison Jeyaraj D Pandian
42
G.B. Pant Hospital, New Delhi M.M. Mehndiratta S.M. Raheja
Chetan Ray 10
Mahavir Hospital & Research Centre, Hy-derabad
Sindhu Joshi 13
Mediciti Hospital, Hyderabad Umesh Tukaram 24 MGM Medical College & MY Hospital, In-fore
Anil Bharani 20
Monilek Hospital & Research Centre, Jaipur
Rajeev Gupta R R Agarwal
Harish Chandra 16
Neuro Centre, Trichy A Sundararajan 39 Poona Hospital, Pune Sudhir Kothari 20 Railway Hospital, Perambur, Chennai A Kalanidhi 7
Rajah Muthaiah Medical College, An-namalainagar
N. Chidambaram S.Balasubramanian
R.Umarani V.Anandi
39
Ruby Hall Clinic, Pune R.S. Wadia S. Bandhishti
5
SP Medical College, Bikaner DK Kochar 61
St John's Medical College Hospital A.K. Roy 24 ITALY
Citta della Pieve Stefano Ricci Maria Grazia Celani Tatiana Mazzoli Enrico Righetti Luciana Favorito
23
IRCCS C. Mondino Giuseppe Micieli Anna Cavallini Guido Giardini Simona Marcheselli Elena Zambrelli
4
Ospedale di Circolo, Busto Arsizio Severino Caprioli Michela Provisione Danilo Zanotta
5
Ospedale di Macerata Luigino De Dominicis Giorgio Giuliani
Roberto Caporalini Marilena Giovagnetti Eugenio Pucci Susanna Paoletti
18
**Perugia Stroke Service As for della Pieve As for della Pieve 67
PAGE 8 ACTIVE RECRUITMENT (CURRENT TO 31 March, 2006)
Site Principal Investigator Research Coordinator Total ITALY continued
Spedali Civili de Brescia Angelo Costa Mauro Magoni
Federica Casoni Raffaella Spezi Veronica Vergani Elisabetta Venturelli Rachele Tortorella
9
Uni of Perugia – Dept of Internal Medicine (Internal & CV Med)
Paolo Gresele
Francesco Guercini Ugo Paliani
20
MALAYSIA Hospital Universiti Sains Malaysia Jafri Malin Abdullah Saufi Awang
Zamzuri Idris Abdul Rahman Izani Ghani Sani Sayuti
68
**University of Malaya Medical Kay-Sin Tan Chong-Tin Tan
13
MOLDOVA City Emergency Hospital Stanislav Groppa Eremei Zota
Viorel Grigor Diana Manea
38
NETHERLANDS Oosterscheldeziekenhuis Rico Sips A.M.Boon
J.C. Doelman F. Visscher
37
Slotervaartziekenhuis Jaap van der Sande W Boogerd HL Hamburger VIH Kwa
12
University Medical Center, Utrecht J van Gijn Ale Algra
Patricia Halkes Moniek Boekweit
42
NEW ZEALAND Auckland, NZ Neil Anderson
Alison Charleston David Spriggs
Patricia Bennett 62
**Hawke’s Bay, NZ John Gommans Marie Pickup Diana Schmid
101
North Shore, NZ Joe Singh Sue Austin 12 Palmerston North, NZ John Bourke 6 Wellington Hospital Harry McNaughton 3
PAKISTAN POF Hospital, Wah Cantt. Wasim Uddin Muhammad Asim Anwar
Hassan Murtaza 140
PHILIPPINES Cagayan de Oro Med. Center Arturo Surdilla Lorena Absin 32 Cagayan Valley Med Center Generaldo Maylem Rex Cubero 1 Cebu Doctor’s Hospital Maria Teresa Canete 84 Cebu Velez General Hospital / Visayas Comm Med Center
Maria Teresa Canete 124
Chong Hua Hospital Maria Teresa Canete 133 **Jose R. Reyes Mem MC Jose Navarro Ciela Balagtas
Macrine Grace Amato 411
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ACTIVE RECRUITMENT (CURRENT TO 31 March, 2006)
Site Principal Investigator Research Coordinator Total
PHILIPPINES Continued
University of Santo Tomas Hospital Johnny Lokin Chinkee Araullo
Leticai Araullo Maricar Yumul
12
Vicente Sotto Memorial Medical Center Maria Teresa Canete 55
PORTUGAL **Hospital de Santa Maria Josè M. Ferro Marisa Costa 21 Hospital Distrital Oliveira de Azeméis Miguel Veloso Elizabeth Marques 61 Hospital Do Visconde de Salreu Ana Paula Sousa Ana Dias 13 Hospital Geral de Santo Antonio Manuel Correia Gabriela Lopes 35
REPUBLIC OF GEORGIA **Sarajishvili Institute of Neurology Alexander Tsiskaridze Tamara Vashadze 118
SERBIA & MONTE NEGRO **University of Novi Sad - Neurology Ivana Divjak Ksenija Bozic
Mirjana Bukinac Vera Diklic Slobadan Gvozdenovic Aleksandar Jovanovic Mirjana Joviecevic Marija Zarkov Milorad Zikic
61
University of Novi Sad – Neurosurgery Ivana Divjak Ljubomir Popovic Tomislav Cigic Djordje Jajic Bozidar Kaurinovic Zeljko Kojadinovic Vladimir Papic Petar Vulekovic
22
SINGAPORE
**Singapore General Christopher Chen Nelson Wong Siew Li Tan
737
SRI LANKA **National Hospital of Sri Lanka Udaya K. Ranawaka
Jagath Wijesekera Muditha Weerakkody 274
UNITED KINGDOM
Altnagelvin Hospital Mark McCarron Mary McNicholl 6
Barking Hospital, Redbridge, Essex, UK Kantha Niranjan 1
Barnsley District Hospital MK Albazzaz Bernadette Hardware 37
Bronglais General Hospital Philip Jones Sarah Roberts 37
PAGE 10 ACTIVE RECRUITMENT (CURRENT TO 31 March, 2006)
Site Principal Investigator Research Coordinator Total UNITED KINGDOM Continued
Luton & Dunstable Hosptial, UK Sekaran Lakshmanan Sakthivel Sethuraman 11 North Tyneside, UK Richard Curless Judy Murdy 152 Nottingham City Hospital, UK Philip Bath
Nikola Sprigg Ulrike Ferentzi Fiona Hammonds
30
Royal Victoria, Belfast, UK Michael Watt Annemarie Hunter 118 Royal Vic Infirmary, Newcastle Helen Rodgers Judy Murdy 92 St Luke’s Hospital Badr El din Ahmed Dafalla
P Rana Venugopal Thattolicanhiratan S Z Tun Dawn Connolly Samantha Wright
13
St Marys Paddington Jeremy Chataway Rahman Chowdhury 7 Stirling Royal Infirmary Alan McKenzie Fiona Dick 2 University Hospital Aintree Anil Sharma Elalaine Bacabac
John Jones Maria Koufali
15
Western General, Edinburgh, UK Martin Dennis Sharon Cameron Hayley Cuthbert Kareen Darley Dawn Lyle Barbara McLaren
131
**Western Infirmary, Glasgow Kennedy Lees Jesse Dawson Matthew Walters Lesley Campbell Yvonne Mcilvenna
299
William Harvey Hospital David Smithard Linda Cowie 44
USA Abington Memorial , USA Kevin R. Booth Michelle Young-Stevenson 4 JFK Hospital / Seton Hall University
Michael Moussouttas Anabel Doumad Susan Fowler Nikolaos Papamitsakis Jennifer Taylor
21
**Ohio State University, USA Andrew Slivka Peggy Notestine 15 South Carolina VA Hospital (recruitment potential reached)
Daniel Vallini 12
University of South Carolina (recruitment potential reached)
Te-Long Hwang Michelle Saverance 7
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PROSPECTIVE SITES
Country Centre Principal Investigator Current Status
Australia National Stroke Research Institute - Austin Health
Geoff Donnan Seeking ethics approval
India K.S. Hospital, Chennai R.S Muralidharan Ethics application approved King George’s Medical College, Lucknow
Maneesh Singh Atul Agarwal
Ethics application submitted
Krishna Institute of Medical Sciences, Hyderabad
Chandra Sekhar Reddy Seeking ethics approval
Mahatma Gandhi Institute of Medical Sciences (MGIMS), Wardha
S P Kalantri Ethics application approved
Sadbhavana Medical & Heart Institute, Patiala
Harminder Singh Ethics application approved
Sir Ganga Ram Hospital, New Delhi Anshu Rohatgi Ethics application submitted
Sri Ramachandra Hospital, Chennai CU Velumurugandran Ethics application approved
Pakistan Dow University of Health Sciences - Civil Hospital, Pakistan
Javed Ismail Ethics application approved
Dow University of Health Sciences - Jinnah Hospital, Pakistan
Javed Ismail Ethics application approved
Philippines West Visayas State University Medical Center, Iloilo City, Philippines
Ryndell G. Alava Seeking ethics approval
Sri Lanka CTU, University of Kelaniya, Sri Lanka Asita de Silva Udaya Ranawaka
Ethics application approved
Sultanate of Oman
Royal Hospital, Muscat George Paulose Shelley Pillai
Seeking ethics approval
Canada McMaster University Chidam Yegappan Seeking ethics approval Robarts Research Institute David Spence Ethics application approved
Saskatoon Christopher Voll Seeking ethics approval University of Calgary Michael Hill Ethics application approved
UK City General Hospital Christine Roffe Ethics application approved
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DRUG SUPPLY
VITATOPS STUDY
FAX TO: Naomi Lillywhite/Bianca Swarts Royal Perth Hospital Fax No: Australia 08 9224 3696
International +61 8 9224 3696 No cover sheet necessary Date: _________ Investigator: __________ Pharmacist: ______________ Delivery Address: __________________ __________________ __________________ __________________ Drug supplies required: _____________________ _____________________ Date required by: ____________