NL-OMON38232已完成4 期
Euroaction plus intensive smoking intervention (varenicline) - Euroaction plus trial
Clinical Research Governance Office,Sir Alexander Fleming Building, Imperial College0 个研究点目标入组 212 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 212
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
- •1. Vascular patients and partners;All patients with a medical diagnosis of coronary or other atherosclerotic disease (see below), and who have been smoking 5 or more cigarettes per day within the last month and are willing to make a quit attempt, 18 years of age or older, but less than 80 years, will be eligible for the comprehensive preventive cardiology programme, including smoking cessation service with Varenicline.;i) Acute myocardial infarction (STEMI or NSTEMI)
- •ii) Unstable angina
- •iii) Stable angina pectoris
- •iv) Elective revascularisation: coronary artery bypass graft (CABG), percutaneus coronary internvention (PCI)
- •vi) Transient ischaemic attack (TIA)
- •vii) Peripheral vascular disease (PVD);The partners of all recruited coronary patients will also be identified and invited to participate in the preventive cardiology programme. Those who are smoking will also be offered the same smoking cessation service including Varenicline.;2. High*risk people and partners;All high risk people - smokers who have been smoking 5 or more cigarettes per day within the last month and willing to make a quit attempt, who meet the inclusion criteria (see below) will be eligible for the preventive cardiology programme, including smoking cessation service with Varenicline: ;Men and women, 50 years of age or older, but less than 80 years, who are smokers willing to make a quit attempt and either
- •i) are newly identified high multifactorial risk individuals: CVD risk equal or greater than 5% over 10 years (now or projected to age 60 years), according to the HeartScore risk estimation system; or
- •ii) have been treated with antihypertensive and/or lipid*lowering therapies; or
- •iii) have diabetes mellitus. ;The partners of all recruited high risk patients will also be identified and invited to participate
- •in the preventive cardiology programme. Those who are smoking will also be offered the same smoking cessation service including Varenicline.
排除标准
- •Patients with coronary artery disease or atherosclerotic vascular disease
- •* severe heart failure
- •* severe physical disability
- •* impaired cognitive function
- •* patients with acute coronary syndromes, with or without revasularisation, will not be included
- •in the study until 2 weeks has elapsed following their coronary event.
- •- hypersensitivity to Varenicline (active substance or to any of the inactive ingredients)
- •- history of suicidal attempt
- •- history of psychosis
- •- bipolar disorders
- •- panic disorders
- •- epilepsy
- •- history of alcohol dependence;High-risk people:;* history of coronary or other atherosclerotic disease
- •* severe heart failure
- •* severe physical disability
- •* impaired cognitive function
- •- hypersensitivity to Varenicline (active substance or to any of the inactive ingredients)
- •- history of suicidal attempt within the last 10 years
- •- history of psychosis
- •- bipolar disorders
- •- panic disorders
- •- epilepsy
- •- history of alcohol dependence
研究者
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