ID

28373

Beschrijving

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

Trefwoorden

Versies (1)
  1. 08-01-18 08-01-18 -
Houder van rechten

Boehringer Ingelheim

Geüploaded op

8 januari 2018

DOI

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Licentie

Creative Commons BY-NC 3.0
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Eligibility criteria RE-SPECT ESUS Embolic Stroke NCT02239120

Engels

Eligibility criteria RE-SPECT ESUS Embolic Stroke NCT02239120

1 Formulieren  
Inclusion criteria
Beschrijving

Inclusion criteria

Ischemic stroke with a brain lesion visualized by neuroimaging (either brain Computed Tomography (CT) or Magnetic Resonance Image (MRI))
Beschrijving

The visualized stroke is a non-lacunar infarct , e.g. involving the cortex or >1.5 cm (>2.0 cm if measured on MRI diffusion-weighted images) in largest diameter if exclusively subcortical.Visualization by CT usually requires delayed imaging >24-48 hours after stroke onset.

Datatype

boolean

The index stroke must have occurred either up to 3 months before randomization (Modified Rankin Scale(mRS) <=3 at randomization) or up to 6 months before randomization (mRS <=3 at randomization) in selected patients that are >= 60 years plus at least one additional risk factor for recurrent stroke
Beschrijving

stroke time of occurence

Datatype

boolean

Arterial imaging or cervical plus TCD ultrasonography does not show extra-cranial or intracranial atherosclerosis with >= 50% luminal stenosis in artery supplying the area of acute ischemia
Beschrijving

atherosclerosis

Datatype

boolean

As evidenced by cardiac monitoring for >= 20 hours with automated rhythm detection, there is absence of AF > 6 minutes in duration
Beschrijving

(within a 20 hour period, either as single episode or cumulative time of multiple episodes)

Datatype

boolean

Exclusion criteria
Beschrijving

Exclusion criteria

Modified Rankin Scale of >=4 at time of randomization or inability to swallow medications
Beschrijving

Modified Rankin Scale

Datatype

boolean

Major risk cardioembolic source of embolism .
Beschrijving

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

Datatype

boolean

Any indication that requires treatment with an anticoagulant as per Investigator`s judgment
Beschrijving

anticoagulant

Datatype

boolean

History of atrial fibrillation (unless it was due to reversible causes such as hyperthyroidism or binge drinking, and has been permanently resolved)
Beschrijving

History of atrial fibrillation

Datatype

boolean

Other specific stroke etiology
Beschrijving

i.e. cerebral arteritis or arterial dissection, migraine with aura/vasospasm, drug abuse

Datatype

boolean

Renal impairment
Beschrijving

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

Datatype

boolean

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Similar models

Eligibility criteria RE-SPECT ESUS Embolic Stroke NCT02239120

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Inclusion criteria
Ischemic stroke
Item
Ischemic stroke with a brain lesion visualized by neuroimaging (either brain Computed Tomography (CT) or Magnetic Resonance Image (MRI))
boolean
stroke time of occurence
Item
The index stroke must have occurred either up to 3 months before randomization (Modified Rankin Scale(mRS) <=3 at randomization) or up to 6 months before randomization (mRS <=3 at randomization) in selected patients that are >= 60 years plus at least one additional risk factor for recurrent stroke
boolean
atherosclerosis
Item
Arterial imaging or cervical plus TCD ultrasonography does not show extra-cranial or intracranial atherosclerosis with >= 50% luminal stenosis in artery supplying the area of acute ischemia
boolean
absence of atrial fibrillation
Item
As evidenced by cardiac monitoring for >= 20 hours with automated rhythm detection, there is absence of AF > 6 minutes in duration
boolean
Item Group
Exclusion criteria
Modified Rankin Scale
Item
Modified Rankin Scale of >=4 at time of randomization or inability to swallow medications
boolean
embolism
Item
Major risk cardioembolic source of embolism .
boolean
anticoagulant
Item
Any indication that requires treatment with an anticoagulant as per Investigator`s judgment
boolean
History of atrial fibrillation
Item
History of atrial fibrillation (unless it was due to reversible causes such as hyperthyroidism or binge drinking, and has been permanently resolved)
boolean
Other specific stroke etiology
Item
Other specific stroke etiology
boolean
Renal impairment
Item
Renal impairment
boolean
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