ISRCTN34087526已完成4 期
Impact of single versus double dose acetylsalicylic acid on platelet function in patients with type 2 diabetes: a randomised crossover study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Inclusion criteria as of 08/02/2016:
- •1. Have type 2 diabetes (defined according to the European Association for the Study of Diabetes (EASD) guidelines)
- •2. Are aged between 18 years and 75 years
- •3. Have not had a coronary event or other indication requiring ASA
- •4. Are on diet alone or stable doses of antihyperglycaemic medication, i.e. the type of medication or dose used has not been changed for at least 3 months
- •5. Have HbA1c levels = 10.0%
- •6. Have triglycerides = 2mmol/l
- •Original inclusion criteria:
- •1. Have type 2 diabetes (defined according to the European Association for the Study of Diabetes (EASD) guidelines)
- •2. Are aged between 18 years and 55 years
- •3. Have not had a coronary event or other indication requiring ASA
- •4. Are on diet alone or stable doses of antihyperglycaemic medication, i.e. the type of medication or dose used has not been changed for at least 3 months
- •5. Have HbA1c levels = 8.0%
- •6. Have triglycerides = 2mmol/l
排除标准
- •1. Have cardiovascular disease, including coronary heart disease, stroke and peripheral artery disease
- •2. Have been taking any dose of ASA, non-steroidal anti-inflammatory drugs, any antiplatelet or antithrombotic drugs within the last 30 days
- •3. Have a history of peptic ulcer disease
- •4. Are treated with insulin
- •5. Have high blood pressure (>150 mmHg systolic or >100 mmHg diastolic
- •6. Have a known bleeding disorder
- •7. Have a known gastrointestinal disorder
- •8. Have evidence of severe hepatic disease or ALT >3 times the upper limit of normal at screening
- •9. Have evidence of severe renal dysfunction or estimated glomerular filtration rate (eGFR) <40ml/min/1.73m2 at screening
- •10. Have a contraindication to ASA, such as allergy or active bleeding
- •11. Have a planned intervention or surgery in the next 3 months
- •12. Are pregnant or lactating women
- •13. Are currently taking part, or have completed, an Investigational Medicinal Product (IMP) trial within the last 3 months
- •14. Are unsuitable for the trial as decided by a clinician
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