ID

28373

Description

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

Keywords

Versions (1)
  1. 1/8/18 1/8/18 -
Copyright Holder

Boehringer Ingelheim

Uploaded on

January 8, 2018

DOI

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License

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

English

Eligibility criteria RE-SPECT ESUS Embolic Stroke NCT02239120

1 forms  
Inclusion criteria
Description

Inclusion criteria

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

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.

Data type

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
Description

stroke time of occurence

Data type

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
Description

atherosclerosis

Data type

boolean

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

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

Data type

boolean

Exclusion criteria
Description

Exclusion criteria

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

Modified Rankin Scale

Data type

boolean

Major risk cardioembolic source of embolism .
Description

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

Data type

boolean

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

anticoagulant

Data type

boolean

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

History of atrial fibrillation

Data type

boolean

Other specific stroke etiology
Description

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

Data type

boolean

Renal impairment
Description

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

Data type

boolean

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Similar models

Eligibility criteria RE-SPECT ESUS Embolic Stroke NCT02239120

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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