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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
Must not have
Patients with an acute coronary syndrome who are not active smokers
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Pivotal Trial
Drug Has Already Been Approved

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had a recent heart problem and I do not smoke.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2022 Phase 4 trial • 39 Patients • NCT04011280
50%
Dysgeusia
50%
Anxiety
36%
Sleep Disturbances
29%
Nausea
21%
Agitation
21%
Depression
21%
Headache
14%
Heartburn
14%
Allergies
14%
Cold
14%
Back Pain
7%
Confusion
7%
Aggression
7%
Panic
7%
Stomach Pain
7%
Dizziness
7%
Fatigue
7%
Leg Spasms
7%
Sinusitis
7%
Angina
7%
Increased Blood Pressure
7%
Palpitations
7%
Cellulitis
7%
Rash
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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

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
1,200 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
~6 spots leftby Oct 2025
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