Risk of post-polypectomy bleeding in patients on uninterrupted Clopidogrel therapy before polypectomy of sessile polyps; a double-blinded randomised controlled trial - PAC-study

Thomas Møller Jensen0 个研究点目标入组 470 人开始时间: 2019年4月26日最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•Patients referred to an elective colonoscopy at HRH (screening, symptom or control)
•In therapy with Clopidogrel (75 mg per day) alone or in combination with ASA
•The patient requires polypectomy of at least one sessile polyp = 20 mm, and no polyps >20 mm or pedunculated polyps are found
•The patient is categorised as at low risk of thrombotic events at the time of the diagnostic colonoscopy, assessed by the responsible doctor, according to the standard guidelines
•Age = 18 years
•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 150
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 320

•High-risk of thromboembolic event:
•o< 6 weeks since uncomplicated coronary event with or without revascularization (Percutaneous coronary intervention (PCI)/bare-metal stent (BMS), coronary artery bypass grafting (CABG))
•o< 3 months since uncomplicated coronary event with revascularization (PCI/drug-eluting stent (DES))
•o<12 months since complicated coronary event (e.g. reinfarction, stent thrombosis)
•o<1 month in stabile coronary artery disease (CAD) with revascularization (PCI/BMS)
•o<3 month since stroke or transient ischemic attack
•Inability to provide informed consent (e.g. mental impairment)
•Not able to read and understand Danish
•Cannot be reached by telephone for follow-up
•In therapy with other antithrombotic medication (except ASA)) such as vitamin-K antagonists (e.g. Warfarin, Phenprocoumon) or NOAK´s (e.g. Pradaxa®, Xarelto®)
•American Society of Anaesthesiology classification class IV
•Fertile women NOT taking anticonception (spiral or hormones). Menopause is defined as at least 12 months of no menstruation before enrollment

发起方

Thomas Møller Jensen