VITATOPS: A Study of VITAmins TO Prevent Stroke

Stroke Clinical Trial

Official title:

VITATOPS - A Study of VITAmins TO Prevent Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00097669
• Other study ID #: ec550
• Status: Completed
• Phase: N/A
• Start date: November 1998
• Est. completion date: June 2009

Study information

• Verified date: January 2014
• Source: VITATOPS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The VITATOPS study is a multi-center, randomized, double blind, placebo-controlled secondary stroke prevention trial to determine whether the addition of vitamin supplements (B12 500 ug, B6 25 mg, Folate 2 mg) to best medical/surgical management (including modification of risk factors) will reduce the combined incidence of recurrent vascular events (stroke, myocardial infarction) and vascular death in patients with recent stroke or transient ischemic attack (TIA). All patients presenting to one of the participating neurologists or general physicians within seven months of stroke (ischemic or hemorrhagic) or TIA (eye or brain) are eligible for this trial. Eligible patients will be randomized in a double-blind fashion to receive multi-vitamins or placebo, 1 tablet daily. The primary outcome event is the composite event "stroke, myocardial infarction, or death from any vascular cause", whichever occurs first. Our target is to recruit a total of 8,000 patients over the next two years with a median follow-up of 2.5 years. Recruitment to the trial began in November 1998 and is planned to continue until December 2005. We aim to complete final follow-up by the end of 2006. However, the Steering Committee will be flexible in dictating the need for ongoing recruitment and continuing follow-up, depending on the overall rate of the primary outcome event in the entire cohort at each interim analysis.

Description:

Background: Epidemiological studies suggest that raised plasma concentrations of total homocysteine (tHcy) may be a common, causal and treatable risk factor for atherothromboembolic ischemic stroke, dementia and depression. Although tHcy can be lowered effectively with small doses of folic acid, vitamin B12 and vitamin B6, it is not known whether lowering tHcy, by means of multivitamin therapy, can prevent stroke and other major atherothromboembolic vascular events, dementia and depression.

Purpose: To determine whether vitamin supplements (folic acid 2 mg, B6 25 mg, B12 500 ug) reduce the risk of stroke, other serious vascular events, dementia and depression in patients with recent stroke or transient ischemic attacks of the brain or eye (TIA).

Methods: An international, multi-center, randomized, double-blind, placebo-controlled clinical trial.

Subjects: Patients with stroke or TIA in the previous 7 months.

Primary outcome measure: Non-fatal stroke, non-fatal myocardial infarction, or death due to vascular causes.

Secondary outcome measures: TIA, Revascularisation procedures, Dementia, Depression.

Sample size calculation: To reliably identify a 15% reduction in relative risk of the primary outcome event from 8% to 6.8% per year with an alpha of 0.05 and power of 80%, 8,000 patients need to be randomized and followed-up for an average of two years.

Current progress: As of November, 2004, more than 4,400 patients have been randomized in 73 centers in 19 countries in five continents: Australia, Austria, Belgium, Brazil, Hong Kong, Italy, Malaysia, Moldova, Netherlands, New Zealand, Pakistan, Philippines, Portugal, Republic of Georgia, Serbia & Monte Negro, Singapore, Sri Lanka, United Kingdom, and United States.

VITATOPS aims to recruit and follow up 8,000 patients between 2000 and 2006, and provide a reliable estimate of the safety and effectiveness of dietary supplementation with folic acid, vitamin B12, and vitamin B6 in reducing recurrent serious vascular events, dementia and depression among a wide range of patients with stroke and TIA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8164
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients presenting within seven months of stroke (ischemic or hemorrhagic) or TIA

• Agree to take study medication

• Be geographically accessible for follow-up

• Provide written informed consent

Exclusion Criteria:

• Taking folic acid or B6 on medical advice

• Use of vitamin supplements containing folate, B6 or B12 (unless patient agrees to take study medication instead of the vitamin supplements which they usually take)

• Taking Methotrexate for any reason

• Pregnancy or women of child-bearing potential who are at risk of pregnancy

• Limited life expectancy

Related Conditions & MeSH terms

• Ischemic Attack, Transient
• Stroke
• Transient Ischemic Attack

Intervention

Drug:
• Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug) or placebo
multivitamin

Other:
• Placebo

Locations

Country	Name	City	State
Australia	Central Coast Neuroscience Research	Gosford
Australia	Bankstown Hospital	New South Wales
Australia	John Hunter Hospital	New South Wales
Australia	Liverpool Hospital	New South Wales
Australia	Royal Perth Hospital	Perth
Australia	Greenslopes Hospital	Queensland
Australia	Nambour Hospital	Queensland
Australia	Flinders & Griffiths	South Australia
Australia	Royal Hobart Hospital	Tasmania
Australia	Alfred Hospital	Victoria
Australia	Beleura & Frankston Hospital	Victoria
Australia	Box Hill Hospital	Victoria
Australia	National Stroke Research Institute - Austin Health	Victoria
Australia	Fremantle Hospital	Western Australia
Australia	Joondalup Hospital	Western Australia
Australia	Sir Charles Gairdner Hospital	Western Australia
Austria	Karl-Franzens University Graz	Graz
Belgium	Algemeen Ziekenhuis Sint-Jan Autonome Verzorgingsinstelling	Brugge
Brazil	Universidade Federal Fluminense & Universidade Federal do Rio de Janeiro	Rio de Janeiro
Georgia	Sarajishvili Institute of Neurology and Neurosurgery	Tbilisi
Hong Kong	Queen Mary Hospital	Pokfulam
Hong Kong	Prince of Wales Hospital	Shatin
India	Rajah Muthaiah Medical College	Annamalainagar
India	St John's Medical College Hospital	Bangalore
India	SP Medical College	Bikaner
India	Baby Memorial Hospital	Calicut
India	KS Hospital	Chennai
India	Amrita Institute of Medical Science	Cochin
India	Care Hopstial	Hyderabad
India	Mahaveer Hospital & Research Centre	Hyderabad
India	Mediciti Hospital	Hyderabad
India	MGM Medical College & MY Hospital	Indore
India	Monilek Hospital	Jaipur
India	Centauri, The Albert Road Clinic	Kolkata
India	CSMMU	Lucknow
India	Christian Medical College & Hospital	Ludhiana
India	G.B. Pant Hospital	New Delhi
India	Sir Ganga Ram Hospital	New Delhi
India	Sadhbavana Medical & Heart Institute	Patiaala
India	Railway Hospital	Perambur
India	Poona Hospital	Pune
India	Ruby Hall Clinic	Pune
India	Neurocenter	Trichy
India	Care Hospital	Visakhapatnam
India	Mahatma Gandhi Institute	Wardha
Italy	Spedali Civili Di Brescia	Brescia
Italy	Ospedale di Circolo de Busto Arsizio	Busto Arsizio
Italy	Ospedale di Macerata	Macerata
Italy	IRCCS Fondazione Istituto Neurologico C Mondino	Pavia
Italy	Perugia Stroke Service & Citta Della Peive	Perugia
Italy	University of Perugia	Perugia
Italy	Ospedale R Guzzardi	Vittoria
Malaysia	Hospital Universiti Sains Malaysia	Kelantan
Malaysia	University of Malaya Medical Centre	Kuala Lumpur
Moldova, Republic of	City Emergency Hospital	Chishinau
Netherlands	Slotervaartziekenhuis	Amsterdam
Netherlands	Oosterscheldeziekenhuis	Goes
Netherlands	University Medical Center Utrecht	Utrecht
New Zealand	Auckland Hospital	Auckland
New Zealand	Hawkes Bay Hospital	Hastings
New Zealand	Palmerston North Hospital	Palmerston North
New Zealand	North Shore Hospital	Takapuna
New Zealand	Wellington Hospital	Wellington South
Pakistan	KRL University	Islamabad
Pakistan	Pakistan Institute of Medical Sciences	Islamabad
Pakistan	DUHS - Civil Hospital	Karachi
Pakistan	DUHS - Jinnah Hospital	Karachi
Pakistan	POF Hospital Wah Cantt.	Wah Cantt
Philippines	Cagayan de Oro Medical Center	Cebu City
Philippines	Cebu Doctor's Hospital	Cebu City
Philippines	Cebu Velez General Hospital/ Visayas Comm. Medical Center	Cebu City
Philippines	Chong Hua Hospital	Cebu City
Philippines	Vicente Sotto Memorial Hospital	Cebu City
Philippines	Cagayan Valley Medical Center	East Santiago City
Philippines	Jose R Reyes Memorial Medical Centre	Manila
Philippines	University Santo Tomas Hospital	Manila
Portugal	Hospital Visconde de Salreu	Estarreja
Portugal	Hospital de Santa Maria	Lisboa
Portugal	Hospital Distrital de Oliverira de Azemeis	Oliveira de Azemeis
Portugal	Hospital Geral de Santo Antonio	Porto
Serbia	University of Novi Sad - Neurology & Neurosurgery	Novisad
Singapore	Singapore General Hospital	Singapore
Sri Lanka	National Hospital of Sri Lanka	Colombo
Sri Lanka	University of Kelaniya	Ragama
United Kingdom	Aberdeen Royal Infirmary	Aberdeen
United Kingdom	Redbridge Health Care	Barking
United Kingdom	Barnsley District Hospital	Barnsley
United Kingdom	The Royal Victoria Hospital	Belfast
United Kingdom	Bronglais General Hospital	Ceredigion
United Kingdom	Western General Hospital, Edinburgh	Edinburgh
United Kingdom	Royal Devon & Exeter Hospital	Exeter
United Kingdom	Western Infirmary	Glasgow
United Kingdom	St Luke's Hospital	Huddersfield
United Kingdom	William Harvey Hospital	Kent
United Kingdom	University Hospital Aintree	Liverpool
United Kingdom	Altnagelvin Hospital	Londonderry
United Kingdom	Luton and Dunstable Hospital	Luton
United Kingdom	Royal Victoria Infirmary, Newcastle	Newcastle
United Kingdom	North Tyneside District General Hospital	North Shields
United Kingdom	Nottingham City Hospital	Nottingham
United Kingdom	St Mary's Paddington Hospital	Paddington
United Kingdom	Rotherham General Hospital	Rotherham
United Kingdom	Stirling Royal Infirmary	Stirling
United Kingdom	Stepping Hill Hospital	Stockport
United Kingdom	University Hospital of North Staffordshire	Stoke on Trent	Shaffordshire
United Kingdom	Musgrove Park Hosptial	Taunton
United Kingdom	Torbay Hospital	Torquay
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	South Carolina VA Hospital	Columbia	South Carolina
United States	University of South Carolina	Columbia	South Carolina
United States	JFK Hospital / Seton Hall University	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
VITATOPS	Medical Health Research Infrastructure Council, Australia, National Health and Medical Research Council, Australia, National Heart Foundation, Australia

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  Georgia,  Hong Kong,  India,  Italy,  Malaysia,  Moldova, Republic of,  Netherlands,  New Zealand,  Pakistan,  Philippines,  Portugal,  Serbia,  Singapore,  Sri Lanka,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-fatal Stroke, Non-fatal Myocardial Infarction or Death Due to Vascular Causes		The primary outcome was measured over a median follow-up period of 3.4 years (interquartile range IQR 1.0-5.5 years).

External Links

•   National Heart Foundation
•   National Stroke Foundation
•   Stroke Society of Australasia Inc.