Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2025-12-27 @ 5:03 AM
Study NCT ID:
NCT03540459
Status:
UNKNOWN
Last Update Posted:
2020-02-07
First Post:
2018-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Central Apnea in Patients Receiving Ticagrelor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-05', 'studyFirstSubmitDate': '2018-05-16', 'studyFirstSubmitQcDate': '2018-05-16', 'lastUpdatePostDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'central apnea index', 'timeFrame': 'at baseline', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'global apnea hypopnea index', 'timeFrame': 'baseline', 'description': 'number of apnea and hypopnea per our'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Coronary Syndrome']}, 'referencesModule': {'references': [{'pmid': '33550173', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all patient receiving ticagrelor 10 days to 2 years after an acute coronary syndrome will be included', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient receiving ticagrelor 10 days to 2 years after an acute coronary syndrome\n\nExclusion Criteria:\n\n* left ventricular ejection fraction \\< 50%\n* patients refusal'}, 'identificationModule': {'nctId': 'NCT03540459', 'briefTitle': 'Central Apnea in Patients Receiving Ticagrelor', 'organization': {'class': 'OTHER', 'fullName': 'Les Grands Prés'}, 'officialTitle': 'Central Apnea in Patients Receiving Ticagrelor', 'orgStudyIdInfo': {'id': 'Les Grands Prés'}}, 'armsInterventionsModule': {'interventions': [{'name': 'sleep polygraphy', 'type': 'DIAGNOSTIC_TEST', 'description': 'sleep polygraphy (one night) in all included patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '77174', 'city': 'Villeneuve-Saint-Denis', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe Meurin, MD', 'role': 'CONTACT', 'email': 'philippemeurin@hotmail.com', 'phone': '0674003218'}, {'name': 'Helene Weber, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Les Grands Prés', 'geoPoint': {'lat': 48.81578, 'lon': 2.79353}}], 'centralContacts': [{'name': 'philippe meurin, MD', 'role': 'CONTACT', 'email': 'philippemeurin@hotmail.com', 'phone': '+33674003218'}, {'name': 'jean yves Tabet', 'role': 'CONTACT', 'email': 'jtabet@free.fr', 'phone': '0033608352073'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Les Grands Prés', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'philippe meurin', 'investigatorAffiliation': 'Les Grands Prés'}}}}