ID
28373
Beschreibung
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
Link
https://clinicaltrials.gov/ct2/show/NCT02239120?term=NCT02239120&cond=NCT02239120&rank=1
Stichworte
Versionen (1)
- 08.01.18 08.01.18 -
Rechteinhaber
Boehringer Ingelheim
Hochgeladen am
8. Januar 2018
DOI
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Lizenz
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
Beschreibung
Exclusion criteria
Beschreibung
Modified Rankin Scale
Datentyp
boolean
Beschreibung
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
Datentyp
boolean
Beschreibung
anticoagulant
Datentyp
boolean
Beschreibung
History of atrial fibrillation
Datentyp
boolean
Beschreibung
i.e. cerebral arteritis or arterial dissection, migraine with aura/vasospasm, drug abuse
Datentyp
boolean
Beschreibung
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
Datentyp
boolean
Ähnliche Modelle
Eligibility criteria RE-SPECT ESUS Embolic Stroke NCT02239120
- StudyEvent: ODM