Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000440224
Ethics application status
Approved
Date submitted
20/05/2009
Date registered
11/06/2009
Date last updated
14/10/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Clopidogrel vs Aspirin in Congestive Heart Failure (CACHE)
Scientific title
A multi-centre, randomised clinical trial examining the effect of Clopidogrel versus Aspirin in addition to optimal medical therapy for heart failure on subsequent heart failure hospitalisation and mortality in patients with class III-IV congestive heart failure.
Secondary ID [1] 282612 0
none
Universal Trial Number (UTN)
Trial acronym
CACHE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart failure 4819 0
Condition category
Condition code
Cardiovascular 237161 237161 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Clopidogrel 75mg oral tablet taken once per day for an average of 3 years (maximum 5 years).
Intervention code [1] 4595 0
Treatment: Drugs
Comparator / control treatment
Aspirin 100mg oral tablet taken once per day for an average of 3 years (maximum 5 years).
Control group
Active

Outcomes
Primary outcome [1] 237981 0
The first occurrence of any heart failure hospitalisation or death from any cause
Timepoint [1] 237981 0
Average of 3 years follow-up
Secondary outcome [1] 242100 0
All cause mortality
Timepoint [1] 242100 0
Average of 3 years follow-up
Secondary outcome [2] 242101 0
All cause hospitalisation
Timepoint [2] 242101 0
Average of 3 years follow-up
Secondary outcome [3] 242102 0
Hospitalisation for bleeding
Timepoint [3] 242102 0
Average of 3 years follow-up
Secondary outcome [4] 242105 0
Hospitalisation for heart failure
Timepoint [4] 242105 0
Average of 3 years follow-up

Eligibility
Key inclusion criteria
1. Men or women age >18 years
2. Symptomatic heart failure
3. Serum N-terminal pro-B-type natriuretic peptide (NT-proBNP) of >600pg/mL
OR NT-proBNP >400pg/mLa + Heart Failure (HF) hospitalisation within last 12 months
4. Treatment with an angiotensin converting enzyme (ACE) inhibitor (unless not tolerated) and ongoing treatment with a diuretic
5. Provision of written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Contraindication to aspirin or clopidogrel
2. Indication for chronic anti-coagulation
3. Heart failure due to a reversible cause or hypertrophic or infiltrative cardiomyopathy
4. Unstable heart failure or treatment regimen
5. Life-limiting systemic illness
6. Severe chronic obstructive pulmonary disease (COPD) (as evidenced by history of mechanical ventilation, need for home oxygen, or treatment with oral corticosteroids) for more than 3 continuous days within 12 months
7. Conditions that might interfere with protocol compliance

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)
Patients who fulfill the eligibilty criteria and give their written informed consent to take part will be randomised centrally using a stratified minimisation method. Patients will be allocated open label aspirin or clopidogrel.
Randomisation will be performed at the National Health and Medical Research Council Clinical Trials Centre (NHMRC CTC)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 1784 0
New Zealand
State/province [1] 1784 0

Funding & Sponsors
Funding source category [1] 4982 0
Government body
Name [1] 4982 0
awaiting confirmation of funding
Country [1] 4982 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
NHMRC Clinical Trials Centre
University of Sydney
Locked Bag 77
Camperdown
NSW 1450
Country
Australia
Secondary sponsor category [1] 4504 0
None
Name [1] 4504 0
Address [1] 4504 0
Country [1] 4504 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7084 0
St Vincent's and Mater HREC (EC00140)
Ethics committee address [1] 7084 0
Ethics committee country [1] 7084 0
Date submitted for ethics approval [1] 7084 0
21/05/2009
Approval date [1] 7084 0
28/07/2009
Ethics approval number [1] 7084 0
HREC/09/SVH/65

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29622 0
A/Prof Christopher Hayward
Address 29622 0
Suite 809, Level 8,
St Vincent's Clinic
438 Victoria St,
Darlinghurst 2010
Country 29622 0
Australia
Phone 29622 0
+61 2 8382 6880
Fax 29622 0
Email 29622 0
[email protected]
Contact person for public queries
Name 12869 0
CACHE Coordinator
Address 12869 0
NHMRC Clinical Trials Centre
University of Sydney
Locked Bag 77
Camperdown
NSW 1450
Country 12869 0
Australia
Phone 12869 0
+61 2 9562 5000
Fax 12869 0
Email 12869 0
[email protected]
Contact person for scientific queries
Name 3797 0
CACHE Coordinator
Address 3797 0
NHMRC Clinical Trials Centre
University of Sydney
Locked Bag 77
Camperdown
NSW 1450
Country 3797 0
Australia
Phone 3797 0
+61 2 9562 5000
Fax 3797 0
Email 3797 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.