RecruitingPhase 4ACTRN12611001132932

Treating Aspirin Resistance with GuidEd Therapy in Diabetes (TARGET-Diabetes) Study

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

Sponsor

RMIT University

Enrollment

400 participants

Start Date

Feb 1, 2012

Study Type

Interventional

Conditions

aspirin resistance

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.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 70 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at whether people with type 2 diabetes or pre-diabetes who do not respond well to aspirin (known as aspirin resistance) might benefit from changes to their aspirin regimen — such as taking it more often, adding another medication, or better controlling blood sugar. High blood sugar is linked to worse platelet activity, which raises heart attack risk. You may be eligible if: - You are between 18 and 70 years old - You have impaired fasting glucose, impaired glucose tolerance, or type 2 diabetes You may NOT be eligible if: - You have a salicylate (aspirin) or thienopyridine allergy - You have a history of haemorrhagic stroke or bleeding disorder - You are pregnant, recently gave birth, or are breastfeeding - You have severe liver disease - You are already taking anticoagulants or other antiplatelet drugs Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 metfor

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

Locations(1)

Australia

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ACTRN12611001132932