Central Apnea in Patients Receiving Ticagrelor

February 5, 2020 updated by: philippe meurin, Les Grands Prés
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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 the main objective of the study will be to look for central sleep apnea

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Villeneuve Saint Denis, France, 77174
        • Recruiting
        • Les Grands Prés
        • Contact:
        • Sub-Investigator:
          • Helene Weber, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • left ventricular ejection fraction < 50%
  • patients refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
central apnea index
Time Frame: at baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
global apnea hypopnea index
Time Frame: baseline
number of apnea and hypopnea per our
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Les Grands Prés

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2018

Primary Completion (ANTICIPATED)

September 1, 2020

Study Completion (ANTICIPATED)

September 30, 2020

Study Registration Dates

First Submitted

May 16, 2018

First Submitted That Met QC Criteria

May 16, 2018

First Posted (ACTUAL)

May 30, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 7, 2020

Last Update Submitted That Met QC Criteria

February 5, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Les Grands Prés

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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