Contact information
Type
Scientific
Primary contact
Prof Tom Meade
ORCID ID
Contact details
Non-communicable Disease Epidemiology Unit
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
+44 (0)20 7927 2182
tom.meade@lshtm.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
TPT
Study hypothesis
That primary prevention treatment in men at high risk with low intensity oral anticoagulation with warfarin and/or 75 mg aspirin daily (i.e. factorial design) reduces coronary heart disease events by 30%.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Thrombosis
Intervention
Oral anticoagulation with warfarin to International Normalised Ratio of 1.5 and/or 75 mg aspirin daily compared with double placebo treatment, i.e. four treatment groups:
1. Active warfarin and active aspirin
2. Active warfarin and placebo aspirin
3. Placebo warfarin and active aspirin
4. Placebo warfarin and placebo aspirin
Intervention type
Drug
Phase
Not Specified
Drug names
Warfarin and aspirin
Primary outcome measures
All coronary heart disease events; fatal and non-fatal coronary events separately.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/1988
Overall trial end date
01/09/1997
Reason abandoned
Eligibility
Participant inclusion criteria
In top 20% of risk score distribution based on smoking history, family history, systolic blood pressure, body mass index, blood cholesterol, factor VII activity, plasma fibrinogen. 5499 men aged 45-69 recruited in 108 practices in the Medical Research Council's General Practice Research Framework.
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
4500 (5499 actually recruited).
Participant exclusion criteria
Already on antithrombotic treatment; high risk of bleeding; liver or renal disease; serious concomitant disease; at discretion of general practitioner
Recruitment start date
01/09/1988
Recruitment end date
01/09/1997
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Non-communicable Disease Epidemiology Unit
London
WC1E 7HT
United Kingdom
Sponsor information
Organisation
Sponsor not defined - Record provided by the Medical Research Council (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
tom.meade@lshtm.ac.uk
Sponsor type
Not defined
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
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
Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=9457092
Publication citations
-
Results
Thrombosis prevention trial: randomised trial of low-intensity oral anticoagulation with warfarin and low-dose aspirin in the primary prevention of ischaemic heart disease in men at increased risk. The Medical Research Council's General Practice Research Framework., Lancet, 1998, 351, 9098, 233-241.