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

NCT ID: NCT01170338

Last Updated: 2010-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Brief Summary

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

Detailed Description

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Conditions

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Smoking Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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active Chantix

active drug to help smoking cessation

Group Type EXPERIMENTAL

Varenicline 100 mg by mouth twice daily

Intervention Type DRUG

this is an active drug to help smoking cessation

sugar pill

Group Type PLACEBO_COMPARATOR

control

Intervention Type DRUG

this is the placebo that will help us maintain a blinded study

Interventions

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Varenicline 100 mg by mouth twice daily

this is an active drug to help smoking cessation

Intervention Type DRUG

control

this is the placebo that will help us maintain a blinded study

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Newark Beth Israel Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Newark Beth Israel Medical Ctr

Locations

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Newark Beth Israel Medical Center

Newark, New Jersey, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Marc Cohen, MD

Role: primary

973-926-7852

Other Identifiers

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2008.68

Identifier Type: -

Identifier Source: org_study_id

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