INSPIRE (International trials of aspirin to prevent recurrent venous thromboembolism)

A prospective combined analysis of the ASPIRE and WARFASA: multi-centre, randomised, double-blind, placebo-controlled clinical trials examining the efficacy and safety of low-dose aspirin after initial anticoagulation to prevent recurrent venous thromboembolism

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000684921

Acronym

INSPIRE

Enrollment

1224

Registered

2011-07-06

Start date

2003-05-01

Completion date

2012-08-01

Last updated

2026-03-07

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

Conditions

None listed

Brief summary

The INSPIRE study is a prospective combined analysis of 2 previously registered studies (ASPIRE and WARFASA). This study is registered before the unblinding of either dataset

Interventions

The ASPIRE and WARFASA studies are international multicentre, randomised, double-blind placebo controlled clinical trials designed to examine the efficacy and safety of low dose aspirin (100mg tablet daily for a maximum of 6 years) to prevent recurrent deep venous thrombosis (DVT) or pulmonary embolism (PE) in patients with a first episide of unprovoked VTE who have completed initial treatment with heparin and warfarin.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

First episode of unprovoked DVT or PE-completion of initial treatment with unfractionated heparin or low-molecular-weight heparin (or effective alternative) and warfarin (recommended treatment duration 6-24 months)

Exclusion criteria

Allergy, intolerance or contraindication for aspirin Clear indication for aspirin, clopidogrel or a conventional (COX 1/2) NSAID. Indication for long-term anticoagulant therapy (eg prosthetic heart valve) Life expectancy of less than 12 months Active bleeding or at high risk of bleeding Anticipated non-adherance to study medications Inability to attend follow-up because of geographical inaccessibility

Outcome results