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Nicotinic Receptor Partial Agonist

CHANTIX (Varenicline) for Smoking Cessation after Acute Coronary Syndrome

Phase 4
Waitlist Available
Research Sponsored by Newark Beth Israel Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
active smokers presenting to hospital with an acute coronary syndrome
Active smokers presenting to hospital with an acute coronary syndrome
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights

Study Summary

This trial looks at the role of a nicotine antagonist in helping patients who have had a heart attack or other acute coronary syndrome to stop smoking.

Who is the study for?
This trial is for active smokers who have been hospitalized with acute coronary syndrome (ACS). It's specifically designed to see if a medication can help them quit smoking. To join, patients must currently be smokers and have ACS. Non-smokers or those without ACS cannot participate.Check my eligibility
What is being tested?
The trial is testing CHANTIX (Varenicline), which acts on nicotine receptors in the brain. Participants will take 100 mg of Varenicline by mouth twice daily to see if it helps them stop smoking after being hospitalized with an acute coronary syndrome.See study design
What are the potential side effects?
Possible side effects of Varenicline may include nausea, sleep disturbances, constipation, gas, vomiting, changes in taste or dry mouth. Some people might also experience mood swings or trouble concentrating.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a smoker and was admitted to the hospital for a heart attack.
Select...
I am a smoker and was admitted to the hospital for a heart-related emergency.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
nicotine levels
Secondary outcome measures
recurrent myocardial ischemia

Side effects data

From 2022 Phase 4 trial • 39 Patients • NCT04011280
50%
Dysgeusia
50%
Anxiety
36%
Sleep Disturbances
29%
Nausea
21%
Depression
21%
Agitation
21%
Headache
14%
Allergies
14%
Heartburn
14%
Cold
14%
Back Pain
7%
Cellulitis
7%
Sinusitis
7%
Stomach Pain
7%
Panic
7%
Angina
7%
Aggression
7%
Palpitations
7%
Rash
7%
Confusion
7%
Dizziness
7%
Fatigue
7%
Leg Spasms
7%
Increased Blood Pressure
7%
Malaise
7%
Weight Gain
7%
Gum Disease
7%
Pharyngitis
7%
Leg Cramps
7%
Muscle Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Low Dose Varenicline
Standard Dose Varenicline

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: active ChantixExperimental Treatment1 Intervention
active drug to help smoking cessation
Group II: sugar pillPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Newark Beth Israel Medical CenterLead Sponsor
11 Previous Clinical Trials
1,199 Total Patients Enrolled

Media Library

Varenicline (Nicotinic Receptor Partial Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT01170338 — Phase 4
Acute Coronary Syndrome Research Study Groups: sugar pill, active Chantix
Acute Coronary Syndrome Clinical Trial 2023: Varenicline Highlights & Side Effects. Trial Name: NCT01170338 — Phase 4
Varenicline (Nicotinic Receptor Partial Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01170338 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being granted admittance to this experiment?

"Unfortunately, this clinical trial is currently not open for recruitment. It was initially posted on January 1st 2008 and last updated on July 26th 2010. If you are seeking alternative studies, there are presently 1502 trials recruiting individuals suffering from acute coronary syndrome as well as a further 26 medical experiments that utilise Varenicline 100 mg by mouth twice daily in the treatment of certain conditions."

Answered by AI

Are there other trials that have gauged the efficacy of Varenicline 100 mg administered orally twice daily?

"Presently, 26 clinical trials for Varenicline 100 mg by mouth twice daily are in progress. Out of these studies, 4 have reached Phase 3 - the final stage before FDA approval. Although most of the research is taking place out of Charleston, South carolina, patients can find 69 locations where they can participate in this medical trial."

Answered by AI

Has the FDA certified Varenicline 100 mg taken orally twice a day as safe?

"The safety rating for Varenicline 100 mg by mouth twice daily was awarded a score of 3 because this is an FDA-approved treatment and has gone through Phase 4 trial."

Answered by AI

Are there still opportunities for people to participate in this research study?

"It appears that the clinical trial referred to has yet to commence recruitment, having first been posted in 2008 and last edited in 2010. However, as of now there are 1528 other trials actively admitting participants for research purposes."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
What site did they apply to?
Newark Beth Israel Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
~6 spots leftby Apr 2025