Back to resultsSafety and Efficacy of the Novel Selective Nicotinic Receptor Partial Agonist, CHANTIX (Varenicline) in Patients With Acute Coronary Syndrome
Primary Purpose
Smoking, Acute Coronary Syndrome
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Varenicline 100 mg by mouth twice daily
control
Sponsored by
About this trial
This is an interventional treatment trial for Smoking focused on measuring smoking, tobacco abuse
Eligibility Criteria
Inclusion Criteria:
- active smokers presenting to hospital with an acute coronary syndrome
Exclusion Criteria:
- patients with an acute coronary syndrome who are not active smokers
Sites / Locations
- Newark Beth Israel Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
active Chantix
sugar pill
Arm Description
active drug to help smoking cessation
Outcomes
Primary Outcome Measures
nicotine levels
Secondary Outcome Measures
recurrent myocardial ischemia
Full Information
NCT ID
NCT01170338
First Posted
July 26, 2010
Last Updated
July 26, 2010
Sponsor
Newark Beth Israel Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01170338
Brief Title
Safety and Efficacy of the Novel Selective Nicotinic Receptor Partial Agonist, CHANTIX (Varenicline) in Patients With Acute Coronary Syndrome
Official Title
Safety and Efficacy of the Novel Selective Nicotinic Receptor Partial Agonist, CHANTIX (Varenicline) in Patients With Acute Coronary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
July 2011 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Newark Beth Israel Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Assess the role of a nicotine antagonist in helping patients presenting to hospital with acute coronary syndrome to stop smoking.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Acute Coronary Syndrome
Keywords
smoking, tobacco abuse
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
active Chantix
Arm Type
Experimental
Arm Description
active drug to help smoking cessation
Arm Title
sugar pill
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Varenicline 100 mg by mouth twice daily
Intervention Description
this is an active drug to help smoking cessation
Intervention Type
Drug
Intervention Name(s)
control
Intervention Description
this is the placebo that will help us maintain a blinded study
Primary Outcome Measure Information:
Title
nicotine levels
Time Frame
1 month
Secondary Outcome Measure Information:
Title
recurrent myocardial ischemia
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
active smokers presenting to hospital with an acute coronary syndrome
Exclusion Criteria:
patients with an acute coronary syndrome who are not active smokers
Facility Information:
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Cohen, MD
Phone
973-926-7852
Email
marcohen@sbhcs.com
First Name & Middle Initial & Last Name & Degree
Marc Cohen, MD
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of the Novel Selective Nicotinic Receptor Partial Agonist, CHANTIX (Varenicline) in Patients With Acute Coronary Syndrome
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