Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000684921
Ethics application status
Approved
Date submitted
5/07/2011
Date registered
6/07/2011
Date last updated
14/10/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
INSPIRE (International trials of aspirin to prevent recurrent venous thromboembolism)
Scientific title
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
Secondary ID [1] 262571 0
ASPIRE - ACTRN012605000004662 (ANZCTR)
Secondary ID [2] 262572 0
WARFASA - NCT00222677 (ClinicalTrials.gov)
Universal Trial Number (UTN)
Nil
Trial acronym
INSPIRE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous thromboembolism 268231 0
Condition category
Condition code
Cardiovascular 268363 268363 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 266902 0
Prevention
Comparator / control treatment
Placebo tablet, once daily
Control group
Placebo

Outcomes
Primary outcome [1] 269133 0
The primary outcome is the composite of objectively diagnosed symptomatic VTE or fatal PE
Timepoint [1] 269133 0
At end of study (4 years treatment duration)
Secondary outcome [1] 276994 0
A) The composite of symptomatic VTE, myocardial infarction, stroke, or cardiovascular death (all serious thrombotic vascular events).
Timepoint [1] 276994 0
At end of study (4 years treatment duration)
Secondary outcome [2] 276995 0
B) Symptomatic VTE , myocardial infarction, stroke, all cause mortality and major bleeding (a measure of net clinical benefit).
Timepoint [2] 276995 0
At end of study (4 years treatment duration)
Secondary outcome [3] 276997 0
C) Major and minor bleeding
Major bleeding defined as clinically overt bleeding
Minor bleeding defined as all other bleeding episodes not meeting the definition of major bleeding, but which lead to discontinuation of study medication
Timepoint [3] 276997 0
At end of study (4 years treatment duration)

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
(ASPIRE) Central randomisation is via a secure web based allocation system

(WARFASA) The randomization sequence will be computer generated. Patients will be randomized according to the consecutive box number assigned to the study center.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation concealment is maintained via a central web based allocation system using a computer programme.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2003
Actual
1/05/2003
Date of last participant enrolment
Anticipated
Actual
1/08/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
2000
Accrual to date
Final
1224
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 3694 0
Italy
State/province [1] 3694 0
Country [2] 3695 0
Argentina
State/province [2] 3695 0
Country [3] 3696 0
India
State/province [3] 3696 0
Country [4] 3697 0
Austria
State/province [4] 3697 0
Country [5] 3698 0
New Zealand
State/province [5] 3698 0

Funding & Sponsors
Funding source category [1] 267375 0
Government body
Name [1] 267375 0
NHMRC (ASPIRE)
Country [1] 267375 0
Australia
Funding source category [2] 267376 0
Government body
Name [2] 267376 0
NZ HRC (ASPIRE)
Country [2] 267376 0
New Zealand
Funding source category [3] 267377 0
Government body
Name [3] 267377 0
NSW Health (ASPIRE)
Country [3] 267377 0
Australia
Funding source category [4] 267378 0
Commercial sector/Industry
Name [4] 267378 0
Bayer (ASPIRE and WARFASA)
Country [4] 267378 0
Germany
Primary sponsor type
University
Name
University of Sydney (ASPIRE)
Address
NHMRC Clinical Trials Centre
92 – 94 Parramatta Road
Camperdown
NSW 2050
Country
Australia
Secondary sponsor category [1] 266439 0
University
Name [1] 266439 0
University of Perugia
Address [1] 266439 0
Perugia, Italy
Country [1] 266439 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269353 0
University of Sydney HREC
Ethics committee address [1] 269353 0
Level 6
Jane Foss Russell Building G02
University of Sydney NSW 2006
Ethics committee country [1] 269353 0
Australia
Date submitted for ethics approval [1] 269353 0
Approval date [1] 269353 0
13/12/2002
Ethics approval number [1] 269353 0
12-2002/3551

Summary
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32833 0
Prof John Simes
Address 32833 0
ASPIRE Study NHMRC Clinical Trials Centre Locked Bag 77 Camperdown NSW 1450
Country 32833 0
Australia
Phone 32833 0
+61 2 9562 5342
Fax 32833 0
Email 32833 0
[email protected]
Contact person for public queries
Name 16080 0
Prof John Simes (Study Chair)
Address 16080 0
ASPIRE Study
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown
NSW 1450
Country 16080 0
Australia
Phone 16080 0
+61 2 9562 5342
Fax 16080 0
+61 2 9562 5094
Email 16080 0
[email protected]
Contact person for scientific queries
Name 7008 0
Prof John Simes (Study Chair)
Address 7008 0
ASPIRE Study
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown
NSW 1450
Country 7008 0
Australia
Phone 7008 0
+61 2 9562 5342
Fax 7008 0
+61 2 9562 5094
Email 7008 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.