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NCT01170338 Clinical Trial

Safety and Efficacy of the Novel Selective Nicotinic Receptor Partial Agonist, CHANTIX (Varenicline) in Patients With Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

Official title:
Safety and Efficacy of the Novel Selective Nicotinic Receptor Partial Agonist, CHANTIX (Varenicline) in Patients With Acute Coronary Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01170338
Other study ID # 2008.68
Secondary ID
Status Recruiting
Phase Phase 4
First received July 26, 2010
Last updated July 26, 2010
Start date January 2008

Study information
Verified date July 2010
Source Newark Beth Israel Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Assess the role of a nicotine antagonist in helping patients presenting to hospital with acute coronary syndrome to stop smoking.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Varenicline 100 mg by mouth twice daily
this is an active drug to help smoking cessation
• control
this is the placebo that will help us maintain a blinded study

Locations
Country Name City State
United States Newark Beth Israel Medical Center Newark New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Newark Beth Israel Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary nicotine levels 1 month No
Secondary recurrent myocardial ischemia 1 month Yes
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