NCT03540459

Brief Summary

all patients with a left ventricular ejection fraction superior or equal to 50% less than 2 years after an acute coronary event and receiving ticagrelor will undergo a sleep polygraphy

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2018

Typical duration for all trials

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

April 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

February 7, 2020

Status Verified

February 1, 2020

Enrollment Period

2.4 years

First QC Date

May 16, 2018

Last Update Submit

February 5, 2020

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

  • central apnea index

    mean central apnea index: apnea hypopnea index (AHI) is the scale commonly used to assess sleep disordered breathing.This scale includes central and obstructive apnea and hypopnea. The main outcome will be the central apnea index: number of central apnea per hour

    at baseline

Secondary Outcomes (1)

  • global apnea hypopnea index

    baseline

Interventions

sleep polygraphyDIAGNOSTIC_TEST

sleep polygraphy (one night) in all included patients

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patient receiving ticagrelor 10 days to 2 years after an acute coronary syndrome will be included

You may qualify if:

  • patient receiving ticagrelor 10 days to 2 years after an acute coronary syndrome

You may not qualify if:

  • left ventricular ejection fraction \< 50%
  • patients refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Les Grands Prés

Villeneuve-Saint-Denis, 77174, France

RECRUITING

Related Publications (1)

  • Meurin P, Ben Driss A, Defrance C, Dumaine R, Weber H, Renaud N, Bonnevie L, Mouram S, Tabet JY. Central sleep apnea after acute coronary syndrome and association with ticagrelor use. Sleep Med. 2021 Apr;80:39-45. doi: 10.1016/j.sleep.2021.01.026. Epub 2021 Jan 20.

    PMID: 33550173DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Central Study Contacts

philippe meurin, MD

CONTACT

+33674003218philippemeurin@hotmail.com

jean yves Tabet

CONTACT

0033608352073jtabet@free.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

May 16, 2018

First Posted

May 30, 2018

Study Start

April 1, 2018

Primary Completion

September 1, 2020

Study Completion

September 30, 2020

Last Updated

February 7, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)