NCT01170338

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 27, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Last Updated

July 27, 2010

Status Verified

July 1, 2010

Enrollment Period

3.5 years

First QC Date

July 26, 2010

Last Update Submit

July 26, 2010

Conditions

SmokingAcute Coronary Syndrome

Keywords

smokingtobacco abuse

Outcome Measures

Primary Outcomes (1)

  • nicotine levels

    1 month

Secondary Outcomes (1)

  • recurrent myocardial ischemia

    1 month

Study Arms (2)

active Chantix

EXPERIMENTAL

active drug to help smoking cessation

Drug: Varenicline 100 mg by mouth twice daily

sugar pill

PLACEBO COMPARATOR
Drug: control

Interventions

Varenicline 100 mg by mouth twice dailyDRUG

this is an active drug to help smoking cessation

active Chantix
controlDRUG

this is the placebo that will help us maintain a blinded study

sugar pill

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • active smokers presenting to hospital with an acute coronary syndrome

You may not qualify if:

  • patients with an acute coronary syndrome who are not active smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

RECRUITING

MeSH Terms

Conditions

SmokingAcute Coronary SyndromeTobacco Use Disorder

Interventions

Varenicline

Condition Hierarchy (Ancestors)

BehaviorMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 26, 2010

First Posted

July 27, 2010

Study Start

January 1, 2008

Primary Completion

July 1, 2011

Last Updated

July 27, 2010

Record last verified: 2010-07

Locations

US(1)