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

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sheba Medical Center
• Collaborators: Barzilai Medical Center; Hadassah Medical Organization
• Treatments: Varenicline

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