Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-03-01 @ 2:44 AM
Study NCT ID:
NCT02265068
Status:
COMPLETED
Last Update Posted:
2018-06-14
First Post:
2014-10-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real Life Long-term Adherence to Ticagrelor After PCI for Acute Coronary Syndromes
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077486', 'term': 'Ticagrelor'}, {'id': 'D000080903', 'term': 'Dual Anti-Platelet Therapy'}], 'ancestors': [{'id': 'D000241', 'term': 'Adenosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D004359', 'term': 'Drug Therapy, Combination'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-13', 'studyFirstSubmitDate': '2014-10-09', 'studyFirstSubmitQcDate': '2014-10-09', 'lastUpdatePostDateStruct': {'date': '2018-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment outcomes of ACS patients receiving Ticagrelor', 'timeFrame': '12 months', 'description': 'Documentation of Events for ACS patients treated with Ticagrelor with follow-up over 12 months'}], 'secondaryOutcomes': [{'measure': 'Long-term use and premature discontinuation of Ticagrelor treatment', 'timeFrame': '12 months', 'description': 'Documentation of time span during which Ticagrelor is taken by patient'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute coronary syndrome (ACS), Ticagrelor'], 'conditions': ['Acute Coronary Syndrome (ACS)']}, 'referencesModule': {'references': [{'pmid': '29878086', 'type': 'RESULT', 'citation': 'Zeymer U, Cully M, Hochadel M. Adherence to dual antiplatelet therapy with ticagrelor in patients with acute coronary syndromes treated with percutaneous coronary intervention in real life. Results of the REAL-TICA registry. Eur Heart J Cardiovasc Pharmacother. 2018 Oct 1;4(4):205-210. doi: 10.1093/ehjcvp/pvy018.'}]}, 'descriptionModule': {'briefSummary': 'Documentation of long-term data regarding ticagrelor use and evaluation of reasons for discontinuation of ticagrelor in patients with ACS', 'detailedDescription': "REAL-TICA is a retrospective non-interventional study to assess the long-term use of ticagrelor in patients with ACS and to evaluate the reasons for discontinuation of ticagrelor.\n\nFor this purpose, selected sites from the ALKK-PCI registry and the respective patients will be identified. The sites' eligibility for this study includes the frequent use of ticagrelor during the acute phase of ACS. Eligible patients are characterised by the diagnosis of ACS and the use of ticagrelor during PCI.\n\nThe eligible sites will be contacted by IHF and asked to contact their eligible patients by letter to obtain informed consent of the patients for the planned 12M follow-up by IHF. A detailed questionnaire on events within the last 12 months, current symptoms, current medication and the use of ticagrelor will be added to the patients' letters. Patients then are asked to return their responses on consent to participate in the study as well as the filled in questionnaire to IHF. Alternatively, patients may choose to receive a telephone call by IHF to answer the detailed questionnaire in person. In case of essential information missing, IHF will contact the primary care physician of the patient directly to obtain information about clinical events and medications."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients from the ALKK-PCI registry discharged alive after PCI for ACS (STEMI and NSTE-ACS) and treated with ticagrelor during the acute phase.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18\n* ACS (STEMI or NSTE-ACS) with PCI\n* Ticagrelor treatment during the acute phase\n* Written informed consent for participation in the study.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02265068', 'acronym': 'Real-TICA', 'briefTitle': 'Real Life Long-term Adherence to Ticagrelor After PCI for Acute Coronary Syndromes', 'organization': {'class': 'OTHER', 'fullName': 'IHF GmbH - Institut für Herzinfarktforschung'}, 'officialTitle': 'Real-TICA Real Life Long-term Adherence to Ticagrelor After PCI for Acute Coronary Syndromes. Evaluation of Antiplatelet Therapy After 12 Months in Patients Undergoing PCI and Treated With Ticagrelor During the Acute Phase of an ACS.', 'orgStudyIdInfo': {'id': 'Real-TICA'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ticagrelor', 'type': 'DRUG', 'otherNames': ['Anti-platelet therapy'], 'description': 'Treatment of ACS patients with Ticagrelor'}]}, 'contactsLocationsModule': {'locations': [{'zip': '99437', 'city': 'Bad Berka', 'country': 'Germany', 'facility': 'Zentralklinik Bad Berka GmbH', 'geoPoint': {'lat': 50.89982, 'lon': 11.28245}}, {'zip': '12351', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Vivantes-Klinikum Neukölln', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '31135', 'city': 'Hildesheim', 'country': 'Germany', 'facility': 'Klinikum Hildesheim GmbH', 'geoPoint': {'lat': 52.15077, 'lon': 9.95112}}, {'zip': '84036', 'city': 'Landshut', 'country': 'Germany', 'facility': 'Krankenhaus Landshut-Achdorf', 'geoPoint': {'lat': 48.52961, 'lon': 12.16179}}, {'city': 'Ludwigshafen', 'country': 'Germany', 'facility': 'Klinikum Ludwigshafen', 'geoPoint': {'lat': 47.81663, 'lon': 9.06138}}, {'zip': '35578', 'city': 'Wetzlar', 'country': 'Germany', 'facility': 'Klinikum-Wetzlar Braunsfeld', 'geoPoint': {'lat': 50.56109, 'lon': 8.50495}}], 'overallOfficials': [{'name': 'Uwe Zeymer, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum Ludwigshafen, Stiftung IHF - Institut für Herzinfarktforschung'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IHF GmbH - Institut für Herzinfarktforschung', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}