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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01170338
Recruitment Status : Unknown
Verified July 2010 by Newark Beth Israel Medical Center.
Recruitment status was:  Recruiting
First Posted : July 27, 2010
Last Update Posted : July 27, 2010
Sponsor:
Information provided by:
Newark Beth Israel Medical Center

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

Condition or disease Intervention/treatment Phase
Smoking Acute Coronary Syndrome Drug: Varenicline 100 mg by mouth twice daily Drug: control Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of the Novel Selective Nicotinic Receptor Partial Agonist, CHANTIX (Varenicline) in Patients With Acute Coronary Syndrome
Study Start Date : January 2008
Estimated Primary Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: active Chantix
active drug to help smoking cessation
Drug: Varenicline 100 mg by mouth twice daily
this is an active drug to help smoking cessation

Placebo Comparator: sugar pill Drug: control
this is the placebo that will help us maintain a blinded study




Primary Outcome Measures :
  1. nicotine levels [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. recurrent myocardial ischemia [ Time Frame: 1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01170338


Locations
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United States, New Jersey
Newark Beth Israel Medical Center Recruiting
Newark, New Jersey, United States, 07112
Contact: Marc Cohen, MD    973-926-7852    marcohen@sbhcs.com   
Principal Investigator: Marc Cohen, MD         
Sponsors and Collaborators
Newark Beth Israel Medical Center

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Responsible Party: Marc Cohen, MD, Newark Beth Israel Medical Ctr
ClinicalTrials.gov Identifier: NCT01170338    
Other Study ID Numbers: 2008.68
First Posted: July 27, 2010    Key Record Dates
Last Update Posted: July 27, 2010
Last Verified: July 2010
Keywords provided by Newark Beth Israel Medical Center:
smoking
tobacco abuse
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs