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Long-term follow-up of participants with electronic health records from the HPS2-THRIVE study

HPS2-THRIVE trial legacy study: long-term follow-up of participants with electronic health records

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN39960384
Enrollment
8035
Registered
2022-08-16
Start date
2022-06-21
Completion date
Unknown
Last updated
2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular disease, dementia, cancer Other

Interventions

Record level electronic health data will be requested from NHS England and equivalent registries in Scotland & Wales. These records will be used to follow-up the original HPS2-THRIVE cohort for an ext

Sponsors

University of Oxford
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Participants are all part of the original HPS2-THRIVE cohort (randomised between 2007 and 2010). They were between 50 and 80 years old when invited to participate. Participants had a history of one of the following: 1. History of myocardial infarction 2. Cerebrovascular atherosclerotic disease (history of presumed ischaemic stroke, transient ischaemic attack or carotid revascularisation) 3. Peripheral arterial disease (i.e. intermittent claudication or history of revascularisation) 4. Diabetes mellitus with any of the above or with other evidence of symptomatic coronary heart disease (i.e. stable or unstable angina, or a history of coronary revascularisation or acute coronary syndrome) For inclusion into the legacy cohort, participants had to be resident in the UK

Exclusion criteria

Exclusion criteria: 1. Participants who have opted out from having their data provided by NHS England 2. Participants who have read the privacy notice and have decided that they do not want their data used in this study.

Design outcomes

Primary

MeasureTime frame
The first planned analyses will be based on at least 15 years’ follow-up from trial initiation with further analyses planned at approximately 5 yearly intervals based on on-going linkage to NHS records. Appropriate analysis methods will be used to compare the risk ratios for first occurrence post-randomisation of each outcome of interest (dementia, stroke, all major cardiovascular disorders, other vascular disease complications, myopathies, heart failure, renal impairment, other health and care outcomes and death) between both allocated treatment groups

Secondary

MeasureTime frame
There are no secondary outcome measures

Countries

England, United Kingdom

Contacts

Public ContactMichelle Nunn
michelle.nunn@ndph.ox.ac.uk+44 1865 743743

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 15, 2026