NCT00243477

Brief Summary

The purpose of this study is to determine the effect of an antidepressive medication (Escitalopram), started preoperatively and given during 6 months, on 6-month and 1 year post-operative morbidity and mortality after coronary artery bypass grafting

Trial Health

87
On Track

Trial Health Score

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

Enrollment
368

participants targeted

Target at P50-P75 for phase_4 coronary-artery-disease

Timeline
Completed

Started Jan 2006

Longer than P75 for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

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

October 20, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 24, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

March 19, 2012

Status Verified

March 1, 2012

Enrollment Period

5.1 years

First QC Date

October 20, 2005

Last Update Submit

March 16, 2012

Conditions

Coronary Artery Disease

Keywords

Coronary Artery BypassSurgery

Outcome Measures

Primary Outcomes (1)

  • Postoperative morbi-mortality

    (1) cardiac : (2) pulmonary (3) neurologic (4) renal (5) rythm (6) infectious(7) any surgery or invasive procedure necessary to treat a postoperative adverse event associated with the initial cardiac surgery ; (8) myocardial infarction during follow-up; (9) congestive heart failure during follow-up; (10) rehospitalization for cardiac related cause, and (11) rehospitalization for non-cardiac related cause

    6 months and 1 year

Secondary Outcomes (2)

  • Quality of life measured by SF-36

    preoperatively and 1,3,6, and 12 months post-operatively

  • Beck depression index (BDI) and Center for Epidemiologic Studies Depression (CES-D) Scale

    preoperatively, and 1,3,6, and 12 months post-operatively.

Study Arms (2)

Treatment

ACTIVE COMPARATOR

Escitalopram given

Drug: Escitalopram

Placebo

PLACEBO COMPARATOR

Placebo given

Drug: Escitalopram

Interventions

EscitalopramDRUG

Escitalopram 10mg or placebo once a day

Also known as: Seroplex
PlaceboTreatment

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing elective coronary artery bypass surgery
  • \> 30 years old

You may not qualify if:

  • Contra-indication to antidepressive treatment
  • Already treated by antidepressive treatment
  • Concomitant cardiac surgery as valve replacement etc.
  • Patients having anticoagulation therapy
  • Pregnant women
  • Hepatic insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sidney Chocron

Besançon, Doubs, 25000, France

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Sidney Chocron, Prof

    Department of Cardiac Surgery - Besancon - France

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,PhD

Study Record Dates

First Submitted

October 20, 2005

First Posted

October 24, 2005

Study Start

January 1, 2006

Primary Completion

February 1, 2011

Study Completion

February 1, 2012

Last Updated

March 19, 2012

Record last verified: 2012-03

Locations

FR(1)