Early In-hospital Initiation of Pharmacotherapy for Smoking Cessation, Concomitant With Nurse-Led Support, in Patients After an Acute Coronary Syndrome (ACS)
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Primary efficacy and Safety endpoint:
研究概览
简要总结
The hypothesis of this study is that combination of Varenicline treatment with nurse-led hospital support during hospitalization and after discharge will result in clinically significant higher long term abstinence rates in smokers with ACS, as compared with nurse led support and placebo, without a significant increase in the risk of adverse events.
详细描述
Smokers hospitalized with Acute Coronary Syndrome (ACS) are at high risk for ischemic events or death. Over two thirds of patients continue to smoke after acute myocardial infarction.
Study objectives will evaluate safety and efficacy of Varenicline vs. placebo in hospitalized ACS patients complemented by nurse-led support. Interventions will continue following discharge for the duration of 12 weeks.
The primary efficacy outcome measure is continuous abstinence rate at 1 year after hospitalization as assessed by self-reporting and verified by CO breath test.
The proposed study is a prospective, double blind, randomized, placebo controlled, multi-center study. Overall 300 patients will be recruited, randomly allocated to active and placebo treatment groups that will receive nurse-led support by trained staff.
Hospitalized ACS smokers will be evaluated by the protocol inclusion/exclusion criteria. Patient's demographics, medical and laboratory data will be obtained including Fagestrom tobacco addiction questionnaire and digitally captured. Participants will be randomly allocated to study groups and will receive, Varenicline or placebo, which will be initiated on the last day of hospitalization and continued for 12 weeks after discharge. Additionally, a structured nurse-led behavioral support program for smoking cessation will be initiated during hospitalization, followed by telephone calls that will provide motivational support and an interview exploring protocol adherence, side effects, changes in health status and smoking status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable clinical condition following a recent (< 10 days) ACS event
- •Active smoking status 30-days prior to ACS
- •Age > 21
- •Life expectancy >1 year
排除标准
- •I. Severe pulmonary disease (FEV1 < 30% predicted ) II. End stage renal failure (eGFR < 20 ml/min/m2) III. Uncontrolled depression or history of psychosis or bipolar disorder or active substance abuse IV. Uncontrolled stage IV hypertension V. Un-resolved life threatening arrhythmia VI. Planned surgical intervention (within < 3 months) VII. Known hypersensitivity to study drug components VIII. Inability to comply with study protocol IX. Active malignancy other than basal cell carcinoma (BCC) X. End-stage congestive heart failure - NYHA IV or decompensated heart failure XI. Pregnancy or lactation
研究组 & 干预措施
study groups
study groups will receive Varenicline
干预措施: Varenicline (Drug)
control group
Participants allocated to the control group will receive placebo
干预措施: placebo (Drug)
结局指标
主要结局
Primary efficacy and Safety endpoint:
时间窗: within 12 month from enrollment
Continuous abstinence rate (CAR) from smoking 1-year after hospitalization as determined by self-reporting and verified by CO testing. Only the combination of the two will be considered as achieving CAR . Non inferior serious adverse event (SAE) rate, defined as: event rate in the intervention group compared to the placebo (SAE according to the FDA definitions) group at 12 months. An interim analysis will be preformed after 33% and 66% of patients have been finished the follow-up duration.
次要结局
- Secondary Outcomes - Weight change(Within 12 month from enrollmen)
- Smoking abstinence at 1 and 6 months(1 and 6 months after randomization)
研究者
Prof. Ilan Goldenberg, MD
Prof. Ilan Goldenberg, MD
Sheba Medical Center