Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-27 @ 7:27 AM
Study NCT ID:
NCT02507856
Status:
COMPLETED
Last Update Posted:
2022-05-10
First Post:
2015-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Record Of the Use of Dabigatran in Patients With Acute Stroke or TIA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-24', 'size': 2117996, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-11-27T04:55', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10044}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-09', 'studyFirstSubmitDate': '2015-07-16', 'studyFirstSubmitQcDate': '2015-07-22', 'lastUpdatePostDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major bleeding event rate', 'timeFrame': 'from study inclusion up to 3 months', 'description': 'Major bleeding event rate within 3 months following the index event (= stroke or TIA)'}], 'secondaryOutcomes': [{'measure': 'Complications during hospitalisation', 'timeFrame': 'from index event up to 1 week', 'description': 'Complications during hospitalisation before study inclusion (= signature of informed consent)'}, {'measure': 'Number of participants with newly occurring or recurrent strokes', 'timeFrame': 'from study inclusion up to 3 months', 'description': 'Stroke (hemorrhagic, ischemic or uncertain classification)'}, {'measure': 'Severity of stroke assessed by modified Rankin Scale (mRS)', 'timeFrame': 'from study inclusion up to 3 months'}, {'measure': 'Number of participants with newly occurring or recurrent TIA', 'timeFrame': 'from study inclusion up to 3 months', 'description': 'transient ischemic attack'}, {'measure': 'Number of participants with systemic embolism', 'timeFrame': 'from study inclusion up to 3 months'}, {'measure': 'Number of participants with pulmonary embolism', 'timeFrame': 'from study inclusion up to 3 months'}, {'measure': 'Number of participants with myocardial infarction', 'timeFrame': 'from study inclusion up to 3 months'}, {'measure': 'Life-threatening bleeding events', 'timeFrame': 'from study inclusion up to 3 months'}, {'measure': 'Any cause of death', 'timeFrame': 'from study inclusion up to 3 months', 'description': 'any cause of death (non-vascular, vascular or unknown cause)'}, {'measure': 'Point in time for withdrawal/change of medication', 'timeFrame': 'from study inclusion up to 3 months'}, {'measure': 'Reason for withdrawal/change of medication', 'timeFrame': 'from study inclusion up to 3 months'}, {'measure': 'Patient compliance', 'timeFrame': 'from study inclusion up to 3 months'}, {'measure': 'Treatment persistence', 'timeFrame': 'from study inclusion up to 3 months'}, {'measure': '(Serious) Adverse Events (AE/SAE)', 'timeFrame': 'from study inclusion up to 3 months'}, {'measure': 'Survival one year after study inclusion', 'timeFrame': 'up to 1 year from study inclusion', 'description': 'any cause of death (non-vascular, vascular or unknown cause)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Brain Ischemia With Non-valvular Atrial Fibrillation', 'Transient Ischemic Attack With Non-valvular Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '39895532', 'type': 'DERIVED', 'citation': 'Grosse GM, Husing A, Stang A, Kuklik N, Brinkmann M, Grond M, Rollnik JD, Marquardt L, Kraft A, Schlemm E, Eggers C, Eschenfelder CC, Weimar C, Diener HC. Prior Anticoagulation and Risk of Hemorrhagic Transformation in Acute Stroke: A Post Hoc Analysis of the PRODAST Study. J Am Heart Assoc. 2025 Feb 4;14(3):e037014. doi: 10.1161/JAHA.124.037014. Epub 2025 Feb 3.'}]}, 'descriptionModule': {'briefSummary': 'The multi-center, prospective PRODAST study is investigating patients with non-valvular atrial fibrillation (AF) who experienced an ischemic stroke or a transient ischemic attack (TIA) recently (≤ 1 week) both with and without previous oral anticoagulation. It consists of a baseline visit and a 3 months central follow-up for patients who were discharged with dabigatran, vitamin K-antagonists, antiplatelets only, or no oral antithrombotic treatment at all. Thus, data on the use of dabigatran and vitamin K-antagonists in routine clinical practice will be collected to describe how dabigatran is prescribed and used in the population of AF patients with recent cerebrovascular events and how these factors influence important outcome and safety events. The utilization of dabigatran will be assessed with regards to treatment persistence, compliance, proportion of patients discontinuing treatment and reason for discontinuation as well clinical endpoints such as major bleeding, stroke or systemic embolism. Due to the fact that patients will be treated according to local medical practice it is possible that medication will be changed during the observation period. In the follow-up, data from the first as well as from the second prescribed medication will be used in the study. To explore a long-term effect of anticoagulation, survival up to one year will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with recent (≤ 1 week from index) ischemic stroke or TIA and with confirmed non-valvular AF (documented by 12 lead ECG, ECG rhythm strip, pacemaker/ICD electrocardiogram, or Holter ECG) will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years at enrollment\n* Male or female patient willing and able to provide written informed consent for data transmission. For patients who are not legally competent to sign this informed consent for data transmission exceptions/special cases are described in the protocol.\n* Patient with ischemic stroke or TIA within the last 7 days.\n* Patient diagnosed with non-valvular AF. Documentation of AF by 12 lead ECG, ECG rhythm strip, monitor print-out, pacemaker/ICD electrocardiogram, Holter ECG (duration of AF episode at least 30 seconds) or written physician´s diagnosis prior to index event needed for all enrolled patients.\n\nExclusion Criteria:\n\n* Presence of any mechanical heart valve, or valve disease that is expected to require valve replacement intervention (surgical or non-surgical) during the next 3 months.\n* Current participation in any randomized clinical trial of an experimental drug or device.\n* Women of childbearing age without anamnestic exclusion of pregnancy or not using an effective contraception or nursing mothers.'}, 'identificationModule': {'nctId': 'NCT02507856', 'acronym': 'PRODAST', 'briefTitle': 'Prospective Record Of the Use of Dabigatran in Patients With Acute Stroke or TIA', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Essen'}, 'officialTitle': 'Prospective Record Of the Use of Dabigatran in Patients With Acute Stroke or TIA', 'orgStudyIdInfo': {'id': 'PRODAST'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'investigational group', 'description': 'early/late dabigatran'}, {'label': 'control group', 'description': 'vitamin k antagonist (vka)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '04600', 'city': 'Altenburg', 'country': 'Germany', 'facility': 'Klinikum Altenburger Land GmbH', 'geoPoint': {'lat': 50.98763, 'lon': 12.43684}}, {'zip': '84503', 'city': 'Altötting', 'country': 'Germany', 'facility': 'Kreisklinik Altötting', 'geoPoint': {'lat': 48.22533, 'lon': 12.67665}}, {'zip': '83043', 'city': 'Bad Aibling', 'country': 'Germany', 'facility': 'Schön Klinik Bad Aibling', 'geoPoint': {'lat': 47.8638, 'lon': 12.01055}}, {'zip': '61352', 'city': 'Bad Homburg', 'country': 'Germany', 'facility': 'Hochtaunus-Kliniken gGmbH, Krankenhaus Bad Homburg', 'geoPoint': {'lat': 50.22683, 'lon': 8.61816}}, {'zip': '97616', 'city': 'Bad Neustadt an der Saale', 'country': 'Germany', 'facility': 'Neurologische Klinik Bad Neustadt a. d. 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