Thrombosis Prevention Trial

ISRCTN	ISRCTN63594484
DOI	https://doi.org/10.1186/ISRCTN63594484
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Tom Meade
Scientific

Non-communicable Disease Epidemiology Unit
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom

Phone	+44 (0)20 7927 2182
Email	tom.meade@lshtm.ac.uk

Study design	Randomised controlled trial.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Prevention
Scientific title
Study acronym	TPT
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Warfarin and aspirin
Primary outcome measure	All coronary heart disease events; fatal and non-fatal coronary events separately.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/09/1988
Completion date	01/09/1997

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target number of participants	4500 (5499 actually recruited).
Key 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.
Key exclusion criteria	Already on antithrombotic treatment; high risk of bleeding; liver or renal disease; serious concomitant disease; at discretion of general practitioner
Date of first enrolment	01/09/1988
Date of final enrolment	01/09/1997

Non-communicable Disease Epidemiology Unit

London
WC1E 7HT
United Kingdom

Sponsor not defined - Record provided by the Medical Research Council (UK)
Not defined

20 Park Crescent
London
W1B 1AL
United Kingdom

Email	tom.meade@lshtm.ac.uk

Research council

Medical Research Council (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results:	24/01/1998		Yes	No