NCT02106637

Brief Summary

The hypothesis of this study is that combination of Varenicline treatment with nurse-led hospital support during hospitalization and after discharge will result in clinically significant higher long term abstinence rates in smokers with ACS, as compared with nurse led support and placebo, without a significant increase in the risk of adverse events.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

March 27, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 8, 2014

Completed
2.5 years until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

December 5, 2017

Status Verified

December 1, 2017

Enrollment Period

1.8 years

First QC Date

March 27, 2014

Last Update Submit

December 4, 2017

Conditions

Acute Coronary SyndromeSmoking Cessation

Keywords

ACSCessation

Outcome Measures

Primary Outcomes (1)

  • Primary efficacy and Safety endpoint:

    Continuous abstinence rate (CAR) from smoking 1-year after hospitalization as determined by self-reporting and verified by CO testing. Only the combination of the two will be considered as achieving CAR . Non inferior serious adverse event (SAE) rate, defined as: event rate in the intervention group compared to the placebo (SAE according to the FDA definitions) group at 12 months. An interim analysis will be preformed after 33% and 66% of patients have been finished the follow-up duration.

    within 12 month from enrollment

Secondary Outcomes (2)

  • Secondary Outcomes - Weight change

    Within 12 month from enrollmen

  • Smoking abstinence at 1 and 6 months

    1 and 6 months after randomization

Study Arms (2)

study groups

ACTIVE COMPARATOR

study groups will receive Varenicline

Drug: Varenicline

control group

PLACEBO COMPARATOR

Participants allocated to the control group will receive placebo

Drug: placebo

Interventions

VareniclineDRUG

drug will be initiated during hospitalization and continued for 12 weeks following discharge

Also known as: CHAMPIX, CHANTIX
study groups
placeboDRUG

placebo

Also known as: Matching placebo for 12 weeks duration
control group

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stable clinical condition following a recent (\< 10 days) ACS event
  • Active smoking status 30-days prior to ACS
  • Age \> 21
  • Life expectancy \>1 year

You may not qualify if:

  • I. Severe pulmonary disease (FEV1 \< 30% predicted ) II. End stage renal failure (eGFR \< 20 ml/min/m2) III. Uncontrolled depression or history of psychosis or bipolar disorder or active substance abuse IV. Uncontrolled stage IV hypertension V. Un-resolved life threatening arrhythmia VI. Planned surgical intervention (within \< 3 months) VII. Known hypersensitivity to study drug components VIII. Inability to comply with study protocol IX. Active malignancy other than basal cell carcinoma (BCC) X. End-stage congestive heart failure - NYHA IV or decompensated heart failure XI. Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, 5262179, Israel

RECRUITING

Related Publications (2)

  • Streck JM, Rigotti NA, Livingstone-Banks J, Tindle HA, Clair C, Munafo MR, Sterling-Maisel C, Hartmann-Boyce J. Interventions for smoking cessation in hospitalised patients. Cochrane Database Syst Rev. 2024 May 21;5(5):CD001837. doi: 10.1002/14651858.CD001837.pub4.

    PMID: 38770804DERIVED

  • Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

    PMID: 37142273DERIVED

MeSH Terms

Conditions

Acute Coronary SyndromeSmoking Cessation

Interventions

VareniclineTime

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalinesPhysical Phenomena

Study Officials

  • Ilan Goldenberg, Prof.

    Sheba Medical Center

    STUDY DIRECTOR

  • Haim Lotan, MD

    Hadassa medical organisation

    PRINCIPAL INVESTIGATOR

  • Haim Yosefi, MD

    Barzili Medical Center

    PRINCIPAL INVESTIGATOR

  • Robert Klempfner, MD

    Sheba Medical Center

    STUDY DIRECTOR

Central Study Contacts

Ilan Goldenberg, MD

CONTACT

972-5302848Ilan.Goldenberg@sheba.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Ilan Goldenberg, MD

Study Record Dates

First Submitted

March 27, 2014

First Posted

April 8, 2014

Study Start

October 1, 2016

Primary Completion

August 1, 2018

Study Completion

December 1, 2018

Last Updated

December 5, 2017

Record last verified: 2017-12

Locations

IL(1)