The Risk of Bleeding After Removal of Large Colorectal Polyps in Patients Continuing or Discontinuing on Aspirin: a Multicenter, Double-blind, Placebo-controlled, Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 760
- 主要终点
- Clinically significant bleeding after colorectal polypectomy
研究概览
简要总结
The risk of bleeding after polypectomy of large colorectal polyps in patients taking aspirin is uncertain. This is a randomized, multi-center, placebo-controlled, double-blind study to compare the risk of significant bleeding after endoscopic polypectomy of large (>=10mm) colorectal polyps in patients continuing or discontinuing on daily acetylsalicylic acid (ASA) use. Eligible patients will be randomly assigned in a 1:1 ratio to a group taking 75mg daily ASA or placebo 7 days before and 14 days following polypectomy. The primary endpoint of the study is bleeding within 30 days from colorectal polypectomy. The secondary endpoints are composite cardiovascular events occurring between the date of randomization and 30 days after polypectomy.
详细描述
Patients chronically taking aspirin (in prophylaxis doses 75-325 mg), with a diagnosis of colorectal polyps ≥ 10 mm in diameter will be enrolled on a routine polypectomy under hospitalization. Meeting the inclusion criteria, after informed consent and a cardiologist consent the patient will receive aspirin/placebo, and The Patient Diary to fill (Visit 1). The patient will be admitted to the Study Center in 6-7 days taking on the aspirin/placebo and prepared for the study (Visit 2). Patient will be under the care of a physician after polypectomy by a minimum of 6 hours. 14 days after polypectomy will be the first control visit, during which the physician will take back patient diary and pack treatment (Visit 3). 30 days after polypectomy will be the second control visit by phone (Visit 4). Patients will be monitored by looking at the end points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 years or older
- •Daily aspirin for primary or secondary prophylaxis
- •Candidate for endoscopic polypectomy of at least one colorectal polyp 10mm or larger
- •Signed written informed consent
- •Written opinion from a cardiologist that the patient can cease taking aspirin for a period of 21 days in the peri-polypectomy period
排除标准
- •Lifelong anticoagulant therapy with warfarin, acenocumarol
- •Concurrent antiplatelet treatment with clopidogrel or ticlopidin
- •Coagulation disorders INR > 1,5, APTT 2xnorm
- •Known hemorrhagic disorder
研究组 & 干预措施
Aspirin
Patients with at least one large polyps taking aspirin in dose 75 mg daily for 21 days (7 days before and 14 days after polypectomy)
干预措施: Aspirin (ASA) (Drug)
Placebo
Patients with at least one large polyps taking placebo daily for 21 days (7 days before and 14 days after polypectomy)
干预措施: Placebo (Drug)
结局指标
主要结局
Clinically significant bleeding after colorectal polypectomy
时间窗: within 30 days after polypectomy
Clinically significant bleeding after polypectomy - any extravasation of blood from the polypectomy site \[immediate (30s after polypectomy), early (to 24ha after polypectomy) or delayed (24ha to 30 days after polypectomy)\], with clinical and/or endoscopic and/or laboratory (Hb decline by more than 3 g%)symptoms and would require endoscopic intervention and/or surgical and/or blood transfusions;
次要结局
- Proportion of composite cardiovascular events, ending unplanned hospitalization in both groups aspirin and placebo(in time from randomisation to 30 days after polipectomy)
- Proportion of clinically significant delayed bleeding in both groups(within 30 days after polipectomy)
研究者
Jaroslaw Regula
Professor in Gastroenterology, MD, PhD
Maria Sklodowska-Curie National Research Institute of Oncology