None listed
Conditions
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.
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 metformin 850 mg once per day for 12 weeks
Sponsors
RMIT University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
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)
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.
Outcome results
None listed