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Varenicline for Smoking Cessation in Hospitalized ACS Patients
NCT02106637Phase 4
Key facts
- Status
- Unknown
- Start
- Oct 2016
- Primary completion
- Aug 2018
- Countries
- 1
- Sponsor
- Sheba Medical Center
- Modality
- Small Molecules
- Drugs
- varenicline
- Conditions
- Tobacco Use Disorder (TUD)
01
Overview
Phase 4, randomised, double-blind trial in Tobacco Use Disorder (TUD) comparing Varenicline Group with Placebo Group (2 arms). Primary endpoint: Continuous Abstinence Rate at 1 Year. Status: unknown.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Varenicline Group
Varenicline + Nurse-led support
Placebo Group
Placebo + Nurse-led support
03
Who it enrols
Adult smokers (>21 years) hospitalized with a recent (<10 days) stable ACS event. Excludes patients with severe pulmonary disease (FEV1 <30%), end-stage renal failure (eGFR <20), uncontrolled hypertension, uncontrolled psychiatric disorders, active substance abuse, life-threatening arrhythmia, NYHA IV heart failure, or active malignancy.
04
Endpoints
Primary
Continuous Abstinence Rate at 1 Year
Secondary
Weight Change
Smoking Abstinence at 1 and 6 Months
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