Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-03-07 @ 10:18 PM
Study NCT ID:
NCT02288260
Status:
COMPLETED
Last Update Posted:
2019-07-15
First Post:
2014-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RuSsian RegisTry of Acute CoronaRy SyndromE TreAtMent and Approach in Dual Antiplatelet Therapy
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': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5470}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-07-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-12', 'studyFirstSubmitDate': '2014-11-07', 'studyFirstSubmitQcDate': '2014-11-07', 'lastUpdatePostDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients receiving different types of short-term antithrombotic treatment according to different type of acute coronary syndrome (STEMI - ST-elevation myocardial infarction, NSTE(Non-ST-elevation)-ACS and Unstable Angina). (Part A)', 'timeFrame': '1st Jan of 2012-1st March of 2015', 'description': 'Patients included in Federal ACS Registry from 1st Jan of 2012 till 1st March of 2015'}, {'measure': 'Proportion of patients taking ticagrelor with cardiovascular (CV) events after discharge from hospital depending on DAT (Dual Antiplatelet Therapy) duration. (Part B)', 'timeFrame': 'Up to 2 years', 'description': 'During follow up'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients who undergo invasive or non-invasive short-term clinical management according to different type of acute coronary syndrome (STEMI, NSTE-ACS and Unstable Angina). (Part A)', 'timeFrame': '1st Jan of 2012-1st March of 2015', 'description': 'Patients included in Federal ACS Registry from 1st Jan of 2012 till 1st March of 2015'}, {'measure': 'Time from first symptoms onset to the time of hospitalization (Part A)', 'timeFrame': '1st Jan of 2012-1st March of 2015', 'description': 'Patients included in Federal ACS Registry from 1st Jan of 2012 till 1st March of 2015'}, {'measure': 'Proportion of patients receiving different types of ACS treatment depending on ACS symptoms duration prior hospitalization. (Part A)', 'timeFrame': '1st Jan of 2012-1st March of 2015', 'description': 'Patients included in Federal ACS Registry from 1st Jan of 2012 till 1st March of 2015'}, {'measure': 'Patients demographic and baseline characteristics (age, gender, weight, height). (Part A)', 'timeFrame': '1st Jan of 2012-1st March of 2015', 'description': 'Patients included in Federal ACS Registry from 1st Jan of 2012 till 1st March of 2015'}, {'measure': 'Proportion of patients with different type of coronary intervention strategies. (Part A)', 'timeFrame': '1st Jan of 2012-1st March of 2015', 'description': 'Patients included in Federal ACS Registry from 1st Jan of 2012 till 1st March of 2015'}, {'measure': 'Proportion of patients who is on ticagrelor treatment during 0-3 months, >3-6 months, >6-9 months, >9-12 months. (Part B)', 'timeFrame': 'Up to 2 years', 'description': 'During follow up'}, {'measure': 'Proportion of patients with ticagrelor treatment interruptions according to different clinical and non-clinical events (bleeds, planned and non-planned medical interventions, etc.) during follow-up. (Part B)', 'timeFrame': 'Up to 2 years', 'description': 'During follow-up period'}, {'measure': 'Proportion of patients with thrombo-embolic events during follow-up depending on DAT therapy duration. (Part B)', 'timeFrame': 'Up to 2 years', 'description': 'During follow-up period'}, {'measure': 'Proportion of patients who discontinued ticagrelor and reason to discontinue ticagrelor treatment. (Part B)', 'timeFrame': 'Up to 2 years', 'description': 'during follow-up period'}, {'measure': 'Proportion of patients with significant violations of treatment regimen with ticagrelor. (Part B)', 'timeFrame': 'Up to 2 years', 'description': 'during follow-up period'}, {'measure': 'Start and stop dates of dual antipatelet therapy and ticagrelor (as part of DAT) and duration of exposure to DAT and ticagrelor in real-life setting. (Part B)', 'timeFrame': 'Up to 2 years', 'description': 'during follow-up period'}, {'measure': 'Proportion of patients who discontinued DAT and the reason of discontinuation of DAT in real-life setting. (Part B)', 'timeFrame': 'Up to 2 years', 'description': 'during follow-up period'}, {'measure': 'Proportion of patients who change DAT components and reason to change of DAT. (Part B)', 'timeFrame': 'Up to 2 years', 'description': 'during follow-up period'}, {'measure': 'Proportion of patients with CV-events (recurrent Myocardial Infarction-MI, stroke, ischemia-driven revascularization, death, etc.) in long-term perspective (second year) after index event in real-life setting. (Part B)', 'timeFrame': 'Up to 2 years', 'description': 'during follow-up period'}, {'measure': 'Proportion of patients using different type of antithrombotic therapy in long-term perspective (second year) after index event. (Part B)', 'timeFrame': 'Up to 2 years', 'description': 'during follow-up period'}, {'measure': 'Proportion of patients who managed by cardiologist, therapist and other physician after discharge from the hospital. (Part B)', 'timeFrame': 'Up to 2 years', 'description': 'during follow-up period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute Coronary Syndrome', 'Russian ACS Registry', 'ticagrelor'], 'conditions': ['Acute Coronary Syndrome']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D1843R00242&attachmentIdentifier=d30a1cc5-a881-45ad-bff9-257f00249024&fileName=D1843R00242_Study_report_synopsis.pdf&versionIdentifier=', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This NIS is a multi-centre, observational, descriptive, cross-sectional study including all consecutive patients with Acute Coronary Syndrome (ACS) and a single-arm, prospective, longitudinal cohort study which will include patients hospitalized for ACS and who are with ticagrelor on discharge from hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study includes patients, in a real-life setting, who are hospitalized for acute coronary syndrome (ACS) within 24 hours of symptom onset and who have a final diagnosis of Unstable Angina (UA), Myocardial Infarction (MI) and were discharged. Including transferred to another medical institution after 24 hours from the moment of hospitalization; transferred from other medical institutions within 24 hours from the moment of initial hospitalization to hospital.\n\nPrincipal of choice in the Single-cohort study: only patients with ticagrelor at discharged.\n\nPatients received the standard medical care as determined by the treating cardiologist.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Part A,B: Subjects whose data have been entered in the Russian ACS Registry\n* PART A,B: Discharged from hospital after MI with ST-segment elevation (STEMI), MI NST segment elevation (NSTEMI) or Unstable angina. Hospitalized during 24 hours of ACS symptoms onset\n* Part B: Patients on ticagrelor at the time of discharge from hospital\n\nExclusion Criteria:\n\n* The existence of serious / severe concomitant diseases which can in the short term (i.e. within 6 months) limit the duration of life\n* Current participation in a clinical trial with a non-licensed investigational medicinal product'}, 'identificationModule': {'nctId': 'NCT02288260', 'acronym': 'STREAM', 'briefTitle': 'RuSsian RegisTry of Acute CoronaRy SyndromE TreAtMent and Approach in Dual Antiplatelet Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'RuSsian RegisTry of Acute CoronaRy SyndromE TreAtMent and Approach in Dual Antiplatelet Therapy (STREAM)', 'orgStudyIdInfo': {'id': 'D1843R00242'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Part A', 'description': 'PATIENTS RECEIVED THE STANDARD MEDICAL CARE AS DETERMINED BY THE TREATING CARDIOLOGIST'}, {'label': 'Part B', 'description': 'Patients on ticagrelor at the time of discharge from hospital'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Arkhangelsk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 64.5461, 'lon': 40.55183}}, {'city': 'Cheboksary', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 56.13218, 'lon': 47.246}}, {'city': 'Irkutsk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 52.29566, 'lon': 104.29076}}, {'city': "Kazan'", 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'city': 'Kemerovo', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.35417, 'lon': 86.10435}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'city': 'Petrozavodsk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 61.78491, 'lon': 34.34691}}, {'city': 'Ryazan', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 54.62696, 'lon': 39.70415}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Stavropol', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 45.03442, 'lon': 41.9642}}, {'city': 'Tomsk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 56.50049, 'lon': 84.98216}}, {'city': 'Tyumen', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 57.15222, 'lon': 65.52722}}, {'city': 'Ufa', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 54.74306, 'lon': 55.96779}}, {'city': 'Vladivostok', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 43.10562, 'lon': 131.87353}}], 'overallOfficials': [{'name': 'Vladimir Bulatov, MCMD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}, {'name': 'Eleva Oschepkova, MD, PROFESSOR OF CARDIOLOGY', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Russian Cardiology Research and Production Complex'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}