Condition category
Circulatory System
Date applied
07/09/2005
Date assigned
08/09/2005
Last edited
29/05/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

private sector organisation

Funding Body Subtype

other non-profit

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

  1. 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.

Additional files

Editorial Notes