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临床试验/NCT04047199
NCT04047199Unknown不适用

Predictive Value of HAS-BLED and CHA2DS2-Vasc Scores for Clinical Outcome After PCI

Assiut University0 个研究点目标入组 173 人开始时间: 2019年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
173
主要终点
Rate of bleeding events

研究概览

简要总结

To assess the predictive value of two scoring systems, namely HAS-BLED and CHA2DS2-VASc scores, to be linked with bleeding events and recurrence of chest pain and other measures of clinical outcome of percutaneous coronary intervention. The investigators aim to provide evidence for local guidelines of optimum options suited to our population

详细描述

Dual-antiplatelet therapy (DAPT) with aspirin and an inhibitor of the platelet P2Y12 receptor is necessary to prevent stent-related thrombotic complications after percutaneous coronary intervention (PCI). (1) Although continuation of DAPT confers substantial and durable benefits that extend beyond the local stented segment, bleeding risk also increases with continued exposure to antiplatelet therapy. (2) Current guidelines give fixed duration of DAPT after coronary intervention but many patients still having early stent thrombosis despite this fixed policy, while others, on the contrary, suffer minor and major bleeding events. These clinical situations should raise the possibility of individualizing therapy. (5) The rationale of this study is to find a new method to tailor the optimal duration of DAPT for each patient by balancing long-term risks for both coronary thrombosis and major bleeding (MB).

The HAS-BLED (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol concomitantly) score has long been used to predict bleeding events in patients on anticoagulation therapy. (3) Also, the CHA2DS2-VASc (congestive heart failure, hypertension, ≥75 years, diabetes, stroke/transient ischemic attack or thromboembolism, vascular disease, elderly, sex) score is a well-established system for prediction of thrombo-embolic events in patients with atrial fibrillation. (4) The aim of the present study is to evaluate the predictive ability of these 2 scoring tools when applied to patients undergoing PCI.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all patients undergoing PCI

排除标准

  • Those who had undergone unexpected immediate CABG

结局指标

主要结局

Rate of bleeding events

时间窗: 6 months after PCI

number of bleeding events (epistaxis, bleeding gums, haematuria, GI bleeding, brain bleeding)

Rate of ischaemic events

时间窗: 6 months after PCI

number of ischaemic events (ACS, TIA, stroke, acute limb ischaemia, GI, ischaemia)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahmoud Osama Sayed Morsy

Principal Investigator

Assiut University

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