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Trial registered on ANZCTR


Registration number
ACTRN12611001132932
Ethics application status
Not yet submitted
Date submitted
28/10/2011
Date registered
28/10/2011
Date last updated
12/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Treating Aspirin Resistance with GuidEd Therapy in Diabetes (TARGET-Diabetes) Study
Scientific title
A pilot prospective randomized open-label blinded endpoint trial of guided antiplatelet therapy with different doses of aspirin versus clopidogrel versus metformin to reduce urinary thromboxane metabolite production in aspirin resistant people with type 2 diabetes
Secondary ID [1] 273292 0
Nil
Universal Trial Number (UTN)
U1111-1125-5314
Trial acronym
TARGET-Diabetes
Linked study record

Health condition
Health condition(s) or problem(s) studied:
aspirin resistance 279055 0
type 2 diabetes 279056 0
Condition category
Condition code
Cardiovascular 279245 279245 0 0
Coronary heart disease
Metabolic and Endocrine 279246 279246 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: oral aspirin 100 mg twice per day for 12 weeks
Arm 2: oral aspirin 100 mg once per day + oral 75 mg once per day clopiodgrel for 12 weeks
Arm 3: oral aspirin 100 mg once per day + oral metformin 850 mg once per day for 12 weeks
Intervention code [1] 283638 0
Treatment: Drugs
Intervention code [2] 283639 0
Prevention
Comparator / control treatment
Oral aspirin 100 mg once per day for 12 weeks
Control group
Active

Outcomes
Primary outcome [1] 279871 0
Urinary 11-dehydro thromboxane B2 : creatinine ratio
Timepoint [1] 279871 0
Prior to randomization (screening visit) and 12 weeks following randomization
Secondary outcome [1] 294647 0
Major adverse cardiovascular event (MACE) including acute myocardial infarction, ischaemic stroke, coronary arterial occlusion, death. Assessed by telephone follow up and data linkage to hospital records.
Timepoint [1] 294647 0
1 year and 5 years

Eligibility
Key inclusion criteria
Impaired fasting glucose IFG (110 – 125 mg / dL) or;
Impaired glucose tolerance IGT (140 – 199 mg / dL) or;
Type-2 diabetes (IFG > 135 mg / dL or IGT > 200 mg / dL)
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
salicylate or thienopyridine allergy or intolerance, history of haemorrhagic stroke, aneurysm or any stroke < 3 months, any thienopyridine < 3 days, history of low platelet count, history of bleeding diathesis, clinical findings in the judgement of the investigator associated with increased risk of bleeding, oral anticoagulation or other antiplatelet therapy, history of withdrawal from study due to non-compliance with medication, any condition associated with poor treatment compliance, including alcoholism, mental illness, or drug dependence, investigative site personnel directly affiliated with the study or immediate family, presently enrolled in another drug study, women who are known to be pregnant, have given birth within the past 90 days, or are breast feeding, concomitant medical illness that in the opinion of the investigator is associated with reduced survival over the expected treatment period, known severe hepatic dysfunction, planned travel or other reason why participant might be unable to cooperate with protocol requirements during the study medication period.

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)
allocation concealment by central computer and phone randomization.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerized sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Blinded assessment of endpoints
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284118 0
Charities/Societies/Foundations
Name [1] 284118 0
Diabetes Australia Research Trust
Address [1] 284118 0
Level 1 101 Northbourne Avenue, TURNER ACT 2612, Australia
Country [1] 284118 0
Australia
Primary sponsor type
University
Name
RMIT University
Address
Plenty Road, Bundoora, VIC 3083
Country
Australia
Secondary sponsor category [1] 269081 0
Individual
Name [1] 269081 0
Dr Matthew Linden
Address [1] 269081 0
M510,
University of Western Australia,
35 Stirling Highway,
CRAWLEY, WA 6009
Country [1] 269081 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 272077 0
Ethics committee address [1] 272077 0
Ethics committee country [1] 272077 0
Date submitted for ethics approval [1] 272077 0
07/11/2011
Approval date [1] 272077 0
Ethics approval number [1] 272077 0

Summary
Brief summary
People with type 2 diabetes have both greater risk of heart attack and are likely to be resistant to drugs such as aspirin commonly used to prevent heart attacks. Furthermore, while some clinicians currently change drug therapy or increase the dose given to people with diabetes, no studies have been done to assess the risk or benefit of such action and there is a need for clear, evidence based, clinical guidelines to be established. Therefore we aim to pilot a study which will assess the effect of increasing frequency of aspirin dosing, adding alternative drug therapy, or better management of hyperglycaemia to improve markers of heart attack risk. We hypothesize that these approaches will improve markers of platelet activation in aspirin resistant diabetics.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33325 0
A/Prof Matthew Linden
Address 33325 0
M510,
University of Western Australia,
35 Stirling Highway,
CRAWLEY, WA 6009
Country 33325 0
Australia
Phone 33325 0
+61893464525
Fax 33325 0
Email 33325 0
matthew.linden@uwa.edu.au
Contact person for public queries
Name 16572 0
A/Prof Matthew Linden
Address 16572 0
M510,
University of Western Australia,
35 Stirling Highway,
CRAWLEY, WA 6009
Country 16572 0
Australia
Phone 16572 0
+61893464525
Fax 16572 0
+61399257063
Email 16572 0
matthew.linden@uwa.edu.au
Contact person for scientific queries
Name 7500 0
A/Prof Matthew Linden
Address 7500 0
M510,
University of Western Australia,
35 Stirling Highway,
CRAWLEY, WA 6009
Country 7500 0
Australia
Phone 7500 0
+61893464525
Fax 7500 0
+61399257063
Email 7500 0
matthew.linden@uwa.edu.au

No data has been provided for results reporting
Summary results
Not applicable