ANZCTR - Registration

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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]

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

type 2 diabetes

Condition category

Condition code

Cardiovascular

Coronary heart disease

Metabolic and Endocrine

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]

Treatment: Drugs

Intervention code [2]

Prevention

Comparator / control treatment

Oral aspirin 100 mg once per day for 12 weeks

Control group

Active

Outcomes

Primary outcome [1]

Urinary 11-dehydro thromboxane B2 : creatinine ratio

Timepoint [1]

Prior to randomization (screening visit) and 12 weeks following randomization

Secondary outcome [1]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/02/2012

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

400

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Diabetes Australia Research Trust

Address [1]

Level 1 101 Northbourne Avenue, TURNER ACT 2612, Australia

Country [1]

Australia

Primary sponsor type

University

Name

RMIT University

Address

Plenty Road, Bundoora, VIC 3083

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Dr Matthew Linden

Address [1]

M510,
University of Western Australia,
35 Stirling Highway,
CRAWLEY, WA 6009

Country [1]

Australia

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

07/11/2011

Approval date [1]

Ethics approval number [1]

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

A/Prof Matthew Linden

Address

M510,
University of Western Australia,
35 Stirling Highway,
CRAWLEY, WA 6009

Country

Australia

Phone

+61893464525

Fax

[email protected]

Contact person for public queries

Name

Matthew Linden

Address

M510,
University of Western Australia,
35 Stirling Highway,
CRAWLEY, WA 6009

Country

Australia

Phone

+61893464525

Fax

+61399257063

[email protected]

Contact person for scientific queries

Name

Matthew Linden

Address

M510,
University of Western Australia,
35 Stirling Highway,
CRAWLEY, WA 6009

Country

Australia

Phone

+61893464525

Fax

+61399257063

[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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Basic results	No			347647-(Uploaded-12-07-2019-11-11-47)-Basic results summary.pdf
Plain language summary	No		Objective: People with type 2 diabetes are more li... [More Details]

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically