LASER: Real Life Antithrombotic Stent Evaluation Registry (LASER)
研究概览
地位
条件
详细说明
The LASER Registry will collect data from unselected patients on how the problem of stents on the background of full anticoagulation is approached by the investigators. On the collected data the LASER registry will
- document the frequently used treatment modalities how patients requiring stents on the background of full anticoagulation with Vitamin K Antagonists are currently managed
- will document the associated cardiac event rates with each currently used treatment strategy
- will document the associated bleeding rates with each currently used treatment strategy
With these data available, the LASER Registry will allow
- to define an optimised treatment regimen for the treatment of patients on full anticoagulation with Vitamin K Antagonists receiving one or more coronary stents
- to allow the appropriate sample size calculation for the design of a subsequent randomised comparison of continuous triple anticoagulation versus this optimised treatment regimen in such patients.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Düren、德国、52351
- Krankenhaus Düren
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Ludwigshafen、德国、67063
- Institut für Herzinfarkforschung Ludwigshafen
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Patients with significant symptomatic coronary artery disease who for this reason undergo PCI with implantation of one or more drug eluting stent(s) (DES) or bare metal stent(s) and requiring Vitamin K Antagonist based full anticoagulation therapy (target INR 2-4,5) for any clinical indication.
The LASER Registry will collect the data of 1000 patients with the need for oral anticoagulation and 1000 matched control patients without the need for oral anticoagulation.
描述
Inclusion Criteria:
- Patients with significant symptomatic coronary artery disease (stable angina class II or more (CCS) , unstable angina, NSTEMI, or STEMI) and who for this reason do undergo percutaneous coronary revascularization with one or more drug eluting stent(s) (DES) or bare metal stent(s)
- Patients requiring Vitamin K Antagonists based full anticoagulation therapy (target INR 2-4,5) for any clinical indication
- Age: >18 years; no upper age limit
- Informed consent has been obtained that the patient agrees to be fol-lowed up for up to one year
Exclusion Criteria:
- Patients who have been treated with a combined anticoagulant & antiplatelet therapy within the previous two months
- Overt or constant occult bleeding that cannot adequately be treated (proton pump inhibitors, H2-blockers e.g.)
- Any contraindication to the use of thienopyridines
- Any contraindication to the use of aspirin
- Severe liver or kidney disease
- Any reason that creates sufficient doubts that follow-up can be obtained with reasonable efforts
- Any other reason that in the eye of the investigator makes the patient unsuitable for the participation in the registry
- For female patients only: pregnant or not on oral contraceptives or child bearing potential
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
合作者和调查者
调查人员
- 首席研究员:Dietrich C. Gulba, MD、Krankenhaus Düren
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.