Early In-hospital Initiation of Pharmacotherapy for Smoking Cessation, Patients After ACS

NCT ID: NCT02106637

Last Updated: 2017-12-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Acute Coronary Syndrome; Smoking Cessation

Keywords

ACS; Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

study groups

study groups will receive Varenicline

Group Type: ACTIVE_COMPARATOR

Varenicline

Intervention Type: DRUG

drug will be initiated during hospitalization and continued for 12 weeks following discharge

control group

Participants allocated to the control group will receive placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo

Interventions

Varenicline

drug will be initiated during hospitalization and continued for 12 weeks following discharge

Intervention Type: DRUG

placebo

placebo

Intervention Type: DRUG

Other Intervention Names

CHAMPIX; CHANTIX; Matching placebo for 12 weeks duration

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: collaborator

Barzilai Medical Center

OTHER

Sponsor Role: collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Prof. Ilan Goldenberg, MD

Prof. Ilan Goldenberg, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ilan Goldenberg, Prof.

Role: STUDY_DIRECTOR

Sheba Medical Center

Haim Lotan, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassa medical organisation

Haim Yosefi, MD

Role: PRINCIPAL_INVESTIGATOR

Barzili Medical Center

Robert Klempfner, MD

Role: STUDY_DIRECTOR

Sheba Medical Center

Locations

Sheba Medical Center

Ramat Gan, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Ilan Goldenberg, MD

Role: CONTACT

Phone: 972-5302848

Email: Ilan.Goldenberg@sheba.health.gov.il

Facility Contacts

Ilan Goldenberg, MD

Role: primary

References

Streck JM, Rigotti NA, Livingstone-Banks J, Tindle HA, Clair C, Munafo MR, Sterling-Maisel C, Hartmann-Boyce J. Interventions for smoking cessation in hospitalised patients. Cochrane Database Syst Rev. 2024 May 21;5(5):CD001837. doi: 10.1002/14651858.CD001837.pub4.

Reference Type: DERIVED

PMID: 38770804 (View on PubMed)

Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

Reference Type: DERIVED

PMID: 37142273 (View on PubMed)

Other Identifiers

CHAMPIX (CHANTIX)

Identifier Type: -

Identifier Source: org_study_id