SmokingPhase 4NCT01170338
Safety and Efficacy of the Novel Selective Nicotinic Receptor Partial Agonist, CHANTIX (Varenicline) in Patients With Acute Coronary Syndrome
A Phase 4 study testing Varenicline 100 mg by mouth twice daily in people with Smoking and Acute Coronary Syndrome, run by Newark Beth Israel Medical Center at 1 site in United States.
Trial summary
Assess the role of a nicotine antagonist in helping patients presenting to hospital with acute coronary syndrome to stop smoking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, Acute Coronary Syndrome
- What is being tested?
- Varenicline 100 mg by mouth twice daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jul 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- active smokers presenting to hospital with an acute coronary syndrome
Who cannot join
- patients with an acute coronary syndrome who are not active smokers
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Marc Cohen, MD, 973-926-7852, marcohen@sbhcs.com
Marc Cohen, MD
About this study
Assess the role of a nicotine antagonist in helping patients presenting to hospital with acute coronary syndrome to stop smoking.
- Conditions
- Smoking, Acute Coronary Syndrome
- Being tested
- Varenicline 100 mg by mouth twice daily, control
- Keywords
- smoking, tobacco abuse
- Medical subject headings
- Smoking, Acute Coronary Syndrome, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varenicline 100 mg by mouth twice dailyDrug
this is an active drug to help smoking cessation
controlDrug
this is the placebo that will help us maintain a blinded study
| Study group | Role | What they receive |
|---|---|---|
| active Chantix | Experimental | active drug to help smoking cessation Receives: Drug: Varenicline 100 mg by mouth twice daily |
| sugar pill | Placebo comparator | Not described Receives: Drug: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
nicotine levels
Measured: 1 month
Secondary outcomes (1)
recurrent myocardial ischemia
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2010 (estimated)
- Study startJan 2008
- Primary completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newark Beth Israel Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01170338
- Sponsor's protocol ID
- 2008.68
- Status last verified
- Jul 2010
- First submitted
- 26 Jul 2010
- Last updated
- 27 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the Novel Selective Nicotinic Receptor Partial Agonist, CHANTIX (Varenicline) in Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT01170338
- Acronym / sponsor ID
- 2008.68
- Conditions
- Smoking, Acute Coronary Syndrome
- Keywords
- smoking, tobacco abuse
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Newark Beth Israel Medical CenterUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jul 2011 (estimated)
- First posted
- 27 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assess the role of a nicotine antagonist in helping patients presenting to hospital with acute coronary syndrome to stop smoking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active Chantix | Experimental | Drug: Varenicline 100 mg by mouth twice dailyactive drug to help smoking cessation |
| sugar pill | Placebo comparator | Drug: control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- active smokers presenting to hospital with an acute coronary syndrome
Key exclusion criteria (1 listed)
- patients with an acute coronary syndrome who are not active smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Varenicline 100 mg by mouth twice dailythis is an active drug to help smoking cessation | Drug | active Chantix |
| controlthis is the placebo that will help us maintain a blinded study | Drug | sugar pill |
Primary outcome
nicotine levels
Time frame: 1 month
1 secondary outcome
recurrent myocardial ischemia
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Varenicline 100 mg by mouth twice daily in people with Smoking and Acute Coronary Syndrome, run by Newark Beth Israel Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nicotine levels (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2010.