NL-OMON52203招募中不适用
RE-DUAL TICLO PCI: Dual Therapy with dabigatran/ticagrelor versus Dual Therapy with dabigatran/clopidogrel in ACS patients with indication for NOAC undergoing PCI. - REDUAL PCI Real Life Registry
Zuyderland Medisch Centrum0 个研究点目标入组 1,000 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •In order to be eligible to participate in this study, the investigator should
- •have carefully considered participation of the patient after extensively
- •consideration between high risk of bleeding and risk of thromboembolic events.
- •Furthermore, a subject must meet all of the following criteria:
- •Age >= 18 years
- •PCI and successful stenting with a Drug Eluting Stent (DES)
- •Patients having an indication for a NOAC or will start with oral
- •anticoagulation (NOAC). Patients with permanent, persistent or paroxysmal
- •atrial fibrillation are eligible.
- •Written informed consent.
- •In addition to the inclusion criteria above, all patients should meet one of
- •the following conditions:
- •Admission to the hospital with ACS (unstable angina, NSTEMI, STEMI)
- •High risk PCI as defined by the presence of one of the following conditions:
- •o Chronic Total Occlusion
- •o Two-stent bifurcation laesion
- •o Total stent length of >60mm in initial procedure
- •o Venous graft stenting
- •Or the presence of medically treated type I or II diabetes mellitus
排除标准
- •Patients unable or unwilling to comply with the protocol or with life
- •expectancy shorter
- •than the duration of the study
- •Glomerular filtration rate < 30 ml/min
- •Heart valve prosthesis (mechanical) Patients with (planned) Transcatheter
- •Aortic Valve Implantation or Aortic Valve Replacement with bioprosthetic valve,
- •are eligible for participation in this study.
- •Cardiogenic shock
- •Contra-indication for Dabigatran, Ticagrelor or Clopidogrel
- •o Liver dysfunction (ALAT, ASAT, Alkaline phosphatase > 3x upper limit of
- •normal) or liver disease (like hepatitis A, B, C)
- •o Lesion or condition with a significant risk of serious bleeding, such as:
- •* current or recent gastrointestinal ulceration;
- •* malignant neoplasms with more bleeding risk;
- •* recent brain / spinal cord injury;
- •* recent surgery on the brain, spinal cord or eyes;
- •* recent or history of intracranial haemorrhage;
- •* oesophageal varices;
- •* arteriovenous malformations;
- •* vascular aneurysms;
- •o severe intraspinal or intracerebral vascular abnormalities.
- •o comedication with cyclosporine, itraconazole, ketoconazole (systemic) and
- •glecaprevir / pibrentasvir, dronedarone, rifampicine, carbamazepine, St. Jan*s
- •wort or phenytoin
- •o Comedication with tacrolimus is not recommended.
- •Allergy to for Dabigatran, Ticagrelor or Clopidogrel
- •Pregnancy
- •Significant thrombocytopenia (platelet count < 50x10 9/L)
- •Major bleeding according to BARC >=3 within the past 6 months.
- •Weight < 50 kg
研究者
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