DRKS00003252已完成3 期
se of Acetylsalicylic Acid (ASA) for Enhanced Early Detection of Colorectal Neoplasms - ASTER
Deutsches Krebsforschungszentrum Heidelberg0 个研究点目标入组 2,422 人开始时间: 2013年3月13日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,422
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 40 Years 至 80 Years（—）
- 性别
- All
入选标准
- •Age 40 to 80 years (both males and females; premenopausal women must have a negative pregnancy test before inclusion into the study, postmenopausal women are women who have not had menstrual bleeding for at least 12 months, or have been surgically sterilized)
- •Planned screening or diagnostic colonoscopy
- •Able to speak and understand German sufficiently to be able to give written informed consent and comply with the study requirements
排除标准
- •1. Factors potentially influencing the primary endpoint
- •a. Diseases/symptoms
- •a1. Chronic inflammatory bowel disease
- •a2. Angiodysplasia of the colon
- •a3. Anamnestic or observed blood loss per anum
- •b. Use of any of the following drugs
- •b1. Within 2 weeks before the study
- •Anticoagulants (including, but not limited to heparin, vitamin K antagonists, e.g. phenprocoumon, warfarin, direct thrombin inhibitors)
- •Antiplatelet drugs (e.g. clopidogrel, prasugrel, ticlopidin)
- •b2. Within 1 week before the study
- •Acetylsalicylic acid
- •b3. Within 3 days before the study
- •NSAIDs and COX-2 inhibitors
- •2. Factors potentially affecting the safety
- •a. Any current clinically relevant signs and symptoms, including
- •a1. Signs and symptoms suggesting acute gastrointestinal ulcer
- •a2. Known clinically relevant thrombocytopenia
- •a3. Acute infection
- •a4. Volume deficit (exsiccosis)
- •a5. Any currently present allergy with dermal reactions, pruritus, or urticaria
- •a6. Severe or insufficiently controlled asthma
- •a7. Severe kidney or liver diseases
- •a8. Any liver cirrhosis
- •a9. Severe, not sufficiently treated heart failure
- •a10. Severe, poorly controlled hypertension
- •a11. Any other unclear symptoms needing further investigation in the opinion of the investigator
- •b. Any of the following anamnestic findings
- •b1. History of severe gastrointestinal bleeding
- •b2. Known hemorrhagic diathesis, including, but not limited to, hypoprothrombinaemia, thrombocytopenia, hemophilia
- •b3. Asthma, except for patients who have used acetylsalicylsäure in the past without negative effects
- •b4. Hypersensitivity against salicylic acid or other ingredients of the study drugs
- •b5. Previous intolerance to NSAIDs, COX-2 inhibitors, or antirheumatic medication
- •b6. Severe gout (e.g. recurrent attacks)
- •b7. Hereditary oxaluria
- •b8. Known G6PD or glutathione peroxidase deficiency
- •b9. Known epilepsy with generalised seizures
- •b10. Severe cardiac diseases (including, but not limited to, myocardial infarction in the past 6 months)
- •c. Intention to use any of the following drugs during the study
- •c1. Anticoagulants
- •c2. Antiplatelet drugs
- •c3. NSAIDs, COX-2 inhibitors
- •c4. Methotrexate = 15 mg/week
- •c5. Systemic glucocorticoids
- •c6. Selective serotonin reuptake inhibitors (SSRIs)
- •c7. Valproic acid
- •d. Planned surgery/dental treatment during participation in the study
- •e. Known pregnancy or lactation
- •3. Other factors
- •a. Known or suspected relevant alcohol abuse
- •b. Known or suspected illicit drug abuse
- 另有 2 项未显示
研究者
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