The impact of single versus double dose acetylsalicylic acid on platelet function in patients with type 2 diabetes (the ASP Study). - The ASP Study (Protocol v1.0 dated 4th July 2011)

niversity of Oxford0 个研究点开始时间: 2011年8月24日最近更新: 2013年5月20日

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•Patients will be eligible for the study if they: • Have type 2 diabetes (defined according to the European Association for the Study of Diabetes guidelines) • Are aged =18 years and <55 years • Have not had a coronary event or other indication requiring ASA • Have been on stable doses of antihyperglycaemic medication, i.e. the type of medication or dose used has not been changed for at least 3 months. • Have HbA1c levels =8.0% • Have triglycerides =2mmol/l
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 24
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•Patients will be ineligible for the study if they: • Have cardiovascular disease, including coronary heart disease, stroke and peripheral artery disease • Have been taking aspirin (ASA), non-steroidal anti-inflammatory drugs, any antiplatelet or antithrombotic drugs within the last 30 days • Have a history of peptic ulcer disease • Are treated with insulin • Have high blood pressure (>150 mmHg systolic or >100 mmHg diastolic) • Have a known bleeding disorder • Have a known gastro-intestinal disorder • Have evidence of severe hepatic disease or ALT >3 times of the upper limit. • Have evidence of renal dysfunction or eGFR <40ml/min/1.73m2 • Have a contraindication to ASA, such as allergy or active bleeding • Have a planned intervention or surgery in the next 3 months • Are pregnant or lactating women • Have a history of any medical condition that would place them at risk as a result of a blood donation • Are currently taking part, or have completed, an Investigational Medicinal Product (IMP) trial within the last 3 months • Are felt to be unsuitable for the trial as decided by a principal investigator

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