EUCTR2013-002980-24-IT进行中（未招募）不适用
Comparative study to evaluate the effect on platelet aggregation of two different doses (20 and 40 mg) of acetylsalicylic acid administered sublingually compared to the dose of 100 mg of acetylsalicylic acid orally in subjects at increased cardiovascular risk. Prospective, randomized, double-blind, parallel-group for a period of three months - ASA-001
IRCCS San Raffaele di Roma0 个研究点目标入组 261 人开始时间: 2013年8月9日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 261
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •men or women
- •age > 18 years
- •moderate-high cardiovascular risk, assessed by using the SCORE system (=1% and <10% for 10-year risk of fatal CVD), according to the European Guidelines on cardiovascular disease prevention in clinical practice
- •written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 130
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 131
排除标准
- •Age < 18 years
- •Positive pregnancy test (ßGCH) performed at the selection visit or results not available, women who are pregnant, women who are breast-feeding, women of childbearing potential who are not using reliable methods available to avoid pregnancy
- •Patients at very high or low cardiovascular risk, having a calculated SCORE =10%
- •History of atrial fibrillation or atrial flutter
- •Patient in treatment with indication to oral anticoagulants or other antithrombotic drugs
- •Patient with history of hypersensitivity or intolerance with acetylsalicylic acid or other non steroidal ant-iinflammatory drugs (NSAIDs)
- •Patients with any history of hereditary angioedema hereditary, idiopathic or associated with acetylsalicylic acid
- •Patients with history of peptic ulcers or gastritis or history of gastrointestinal bleeding associated to acetylsalicylic acid or other non steroidal anti-inflammatory drugs (NSAIDs)
- •Patients with severe gastro-intestinal tract disorders
- •Patient with asthma or NSAID-precipitated bronchospasm
- •Patients with known coagulation disorders or with abnormal platelet count (< 100 000 per mm3 or > 400 000 per mm3) or with other acquired causes of impaired platelet aggregation, including uremia and paraproteinemia (monoclonal gammopathy).
- •Patients with haemophilia or other bleeding disorders
- •Patients with myeloproliferative disorders
- •Patients with severe chronic kidney disease (GFR ,30 mL/min/ 1.73 m2), using Cockcroft’s formula:
- •o men = (140 - age) x weight (kg)/(0.814 x creatinine level (µmol/lL)).
- •o women = 0.85 x [(140 - age) x weight (kg)/(0.814 x creatinine level (µmol/lL))].
- •Patients with known liver disease or biliary disease (chronic hepatitis, cirrhosis, etc) or with ALAT or ASAT upper than 3 times the upper limit of normal laboratory range.
- •Patient with hyperkalemia
- •History of alcoholism or drug abuse.
- •Patients unlikely to co-operate in the study or to comply well with treatment or with the study visits.
- •Participation in another study at the same time or within the preceding 30 days, (or a longer period in accordance to the local regulations).
- •History of severe disease likely to interfere with the conduct of the study, severe uncontrolled infection, evolving neoplasm.
- •History of severe mental or psychiatric disorder, severe depression or history of severe depression, e.g. requiring an hospitalisation or at high risk of suicide attempt.
- •Endocrine diseases: uncontrolled dys-thyroidia, Cushing’s syndrome, acromegalia, hyperparathyroidia.
- •Patient with a life expectancy of less than the 15 month duration of the study in opinion to the investigator.
- •Patients with HIV or taking drugs for HIV
研究者
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