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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Newark Beth Israel Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Newark Beth Israel Medical Center
ClinicalTrials.gov Identifier:
NCT01170338
First received: July 26, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Smoking
U.S. FDA Resources

Further study details as provided by Newark Beth Israel Medical Center:

Primary Outcome Measures:
  • nicotine levels [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • recurrent myocardial ischemia [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: January 2008
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01170338

Locations
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
  More Information

No publications provided

Responsible Party: Marc Cohen, MD, Newark Beth Israel Medical Ctr
ClinicalTrials.gov Identifier: NCT01170338     History of Changes
Other Study ID Numbers: 2008.68
Study First Received: July 26, 2010
Last Updated: July 26, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Newark Beth Israel Medical Center:
smoking
tobacco abuse

Additional relevant MeSH terms:
Smoking
Acute Coronary Syndrome
Habits
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
 Signs and Symptoms
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 17, 2012