ID
28373
Beskrivning
This trial will enroll approximately 6,000 patients with recent embolic stroke of unknown source (ESUS). Patients will be randomized to dabigatran or acetylsalicyclic acid (ASA) (1:1 ratio) and have visits every three months. The study doctor may prescribe blinded concomitant ASA for pts with coronary artery disease but this is not mandatory. All Adverse Events (AEs), Serious Adverse Events (SAEs), outcome events will be recorded. The trial will conclude when the required number of stroke events are positively adjudicated which is estimated to take 3 years (including 2.5 years of enrollment). Sponsor / Information provided by (Responsible Party): Boehringer Ingelheim. https://clinicaltrials.gov/ct2/show/NCT02239120?term=NCT02239120&cond=NCT02239120&rank=1
Länk
https://clinicaltrials.gov/ct2/show/NCT02239120?term=NCT02239120&cond=NCT02239120&rank=1
Nyckelord
Versioner (1)
- 2018-01-08 2018-01-08 -
Rättsinnehavare
Boehringer Ingelheim
Uppladdad den
8 januari 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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Eligibility criteria RE-SPECT ESUS Embolic Stroke NCT02239120
Eligibility criteria RE-SPECT ESUS Embolic Stroke NCT02239120
- StudyEvent: ODM
Beskrivning
Exclusion criteria
Beskrivning
Modified Rankin Scale
Datatyp
boolean
Beskrivning
such as: a) intracardiac thrombus as evidenced by transthoracic or transesophageal echocardiography, b) paroxysmal, persistent or permanent AF, c) atrial flutter, d) prosthetic cardiac valve (mitral or aortic, bioprosthetic or mechanical), e) atrial myxoma, f) other cardiac tumors, g) moderate or severe mitral stenosis, h) recent (< 4weeks) myocardial infarction, i) valvular vegetations, or j) infective endocarditis
Datatyp
boolean
Beskrivning
anticoagulant
Datatyp
boolean
Beskrivning
History of atrial fibrillation
Datatyp
boolean
Beskrivning
i.e. cerebral arteritis or arterial dissection, migraine with aura/vasospasm, drug abuse
Datatyp
boolean
Beskrivning
Renal impairment with estimated creatinine clearance (as calculated by Cockcroft-Gault equation) <30mL/min at screening, or where Investigator expects creatinine clearance is likely to drop below 30mL/min during the course of the study
Datatyp
boolean
Similar models
Eligibility criteria RE-SPECT ESUS Embolic Stroke NCT02239120
- StudyEvent: ODM