DRKS00020940招募中3 期
Effect of low-dose acetylsalicylic acid on early detection of advanced colorectal neoplasms - ASTER 2
Deutsches Krebsforschungszentrum (DKFZ)0 个研究点目标入组 1,225 人开始时间: 2020年10月6日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,225
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
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 40 Years 至 79 Years（—）
- 性别
- Male
入选标准
- •Age 40 to 79 years
- •Planned screening colonoscopy
- •No history of colorectal cancer
- •No regular use of any drug with an effect on the blood clotting/coagulation system
- •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
- •No screeening colonscopy (e.g. diagnostic or surveillance colonoscopy)
- •Colonoscopy due to visible blood in stool
- •Colonoscopy due to positive fecal occult blood test
- •Diseases/symptoms or anamnestic finding:
- •o Chronic inflammatory bowel disease (e.g. Crohn’s disease, colitis ulcerosa)
- •o Angiodysplasia of the colon
- •o Signs or symptoms suggesting acute gastrointestinal ulcer
- •o Chronic constipation (less than 3 bowel movements per week)
- •o Anamnestic or observed blood loss per anum
- •o History of severe gastrointestinal bleeding
- •o Severe or insufficiently controlled asthma
- •o Asthma, except for patients who have used acetylsalicylic acid in the past without negative effects
- •o Acute infection
- •o Severe, not sufficiently treated heart failure
- •o Severe, poorly controlled arterial hypertension
- •o Severe cardiac diseases (including, but not limited to, myocardial infarction in the past 6 months)
- •o Known clinically relevant thrombocytopenia
- •o Known hemorrhagic diathesis, including, but not limited to, hypoprothrombinaemia, severe thrombocytopenia, hemophilia
- •o Known glucose 6 phosphate dehydrogenase (G6PD) deficiency
- •o Known glutathione peroxidase deficiency
- •o Volume deficit (exsiccosis)
- •o Severe kidney (e.g. GFR <30 ml/min)
- •o Severe liver disease (e.g. liver cirrhosis)
- •o Severe gout (e.g. recurrent attacks)
- •o Hereditary oxaluria
- •o Known epilepsy with generalized seizures
- •o Any currently present allergy with dermal reactions (e.g. urticaria) or pruritus
- •o Hypersensitivity against salicylic acid or other ingredients of the study drug (e.g. corn starch, microcrystalline cellulose, cellulose powder)
- •o Previous intolerance to NSAIDs, COX-2 inhibitors, or antirheumatic medication
- •o Any other unclear symptom needing further investigation in the opinion of the investigator
- •Use of any drug with an effect on the blood clotting/coagulation system:
- •o Within 2 weeks before the study:
- •- Anticoagulants (including, but not limited to heparin, vitamin K antagonists [e.g. phenprocoumon, warfarin]), direct thrombin inhibitors (e.g. dabigatran), or factor Xa inhibitors (e.g. apixaban, rivaroxaban, edoxaban)
- •- P2Y12-Inhibitors (e.g. clopidogrel, prasugrel, ticagrelor)
- •o Within 1 week before the study:
- •- Acetylsalicylic acid (ASA)
- •o Within 3 days before the study
- •- NSAIDs (e.g. ibuprofen, diclofenac, naproxen) including COX-2 inhibitors (e.g. celecoxib, etoricoxib)
- •Intention to use any of the following drugs during the study:
- •o Anticoagulants
- •o P2Y12-Inhibitors
- •o NSAIDs, including COX-2 inhibitors
- •o Methotrexate = 15 mg/week
- •o Systemic glucocorticoids
- •o Selective serotonin reuptake inhibitors
- •o Valproic acid
- •Planned surgery/dental treatment during the study
- •Known or suspected alcohol abuse
- •Known or suspected illicit drug abuse
- •Suspected non-compliance with the study procedures
- 另有 1 项未显示
研究者
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