Early In-hospital Initiation of Pharmacotherapy for Smoking Cessation, Patients After ACS
Early In-hospital Initiation of Pharmacotherapy for Smoking Cessation, Concomitant With Nurse-Led Support, in Patients After an Acute Coronary Syndrome (ACS)
研究概览
详细说明
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.
All patients will be re-assessed at one, 3 and 12 -months post discharge. Follow-up visits will comprise of a physical examination, adverse event assessment and CO breath testing.
Cardiovascular diseases are the leading cause of death in Western countries, and cigarette smoking has a clear cause-and -effect relationship with atherosclerotic disease (1). Smokers hospitalized with Acute Coronary Syndrome (ACS) are at high risk for subsequent ischemic events and present 50% higher chance of death in the first 2 years (2). Nevertheless, over two thirds of patients continue to smoke after an acute myocardial infarction. Varenicline has been shown to be highly effective smoking cessation intervention (4), yet concerns have been raised regarding safety in coronary patients (5).
A significant number of eligible patients do not receive structured smoking cessation interventions following ACS. Initiation of secondary prevention interventions during hospital stay has been shown to be highly effective for other key secondary prevention interventions (i.e. statins, beta blockers).
Moreover, combination of Varenicline treatment with nurse-led hospital support, initiated early during hospitalization is expected to result in better adherence and better long-term abstinence rates in smokers with a recent ACS.
This proposed study would be the first Israeli trial with Varenicline.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Ilan Goldenberg, MD
- 电话号码:972-5302848
- 邮箱:ilan.goldenberg@sheba.health.gov.il
学习地点
-
-
-
Ramat Gan、以色列、5262179
- 招聘中
- Sheba Medical Center
-
接触:
- Ilan Goldenberg, MD
- 电话号码:972-5302848
- 邮箱:ilan.goldenberg@sheba.health.gov.il
-
-
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
描述
Inclusion Criteria:
- Stable clinical condition following a recent (< 10 days) ACS event
- Active smoking status 30-days prior to ACS
- Age > 21
- Life expectancy >1 year
Exclusion Criteria:
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:study groups
study groups will receive Varenicline
|
drug will be initiated during hospitalization and continued for 12 weeks following discharge
其他名称:
|
安慰剂比较:control group
Participants allocated to the control group will receive placebo
|
安慰剂
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Primary efficacy and Safety endpoint:
大体时间: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. |
within 12 month from enrollment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Secondary Outcomes - Weight change
大体时间:Within 12 month from enrollmen
|
Weight change in the intervention group vs. placebo , Baseline vs. 12 month visit
|
Within 12 month from enrollmen
|
Smoking abstinence at 1 and 6 months
大体时间:1 and 6 months after randomization
|
CAR at 1- and 6-month visits as reported and verified by CO breath analysis
|
1 and 6 months after randomization
|
合作者和调查者
调查人员
- 研究主任:Ilan Goldenberg, Prof.、Sheba Medical Center
- 首席研究员:Haim Lotan, MD、Hadassa medical organisation
- 首席研究员:Haim Yosefi, MD、Barzili Medical Center
- 研究主任:Robert Klempfner, MD、Sheba Medical Center
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
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 (实际的)
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.
安慰剂的临床试验
-
City of Hope Medical CenterNational Cancer Institute (NCI)主动,不招人造血和淋巴细胞肿瘤 | 骨髓纤维化 | 慢性淋巴细胞白血病 | 缓解期成人急性髓性白血病 | 骨髓增生异常综合症 | 缓解期成人急性淋巴细胞白血病 | 骨髓增殖性肿瘤 | 慢性期慢性粒细胞白血病,BCR-ABL1 阳性 | 成人淋巴母细胞淋巴瘤 | 加速期慢性粒细胞白血病,BCR-ABL1 阳性 | HLA-A*0201 阳性细胞存在 | 巨细胞病毒感染 | 成人霍奇金淋巴瘤 | 成人非霍奇金淋巴瘤美国
-
Mila (bMotion Technologies)完全的
-
Universidad Autonoma de MadridCentro Universitario La Salle完全的