Dabigatran etexilate for Secondary Stroke Prevention in Patients with Embolic Stroke of Undetermined Source (RE-SPECT ESUS)
- Conditions
- A study to compare dabigatran etexilate to acetylsalicylic acid in preventing recurrent stroke for patients that already had a stroke caused by an embolus (clot). Despite testing, it is unknown where in the body the embolus developed.MedDRA version: 20.0 Level: PT Classification code 10067167 Term: Cerebellar embolism System Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0 Level: PT Classification code 10014498 Term: Embolic stroke System Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0 Level: PT Classification code 10060839 Term: Embolic cerebral infarction System Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0 Level: PT Classification code 10074422 Term: Brain stem embolism System Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2013-003444-24-DE
- Lead Sponsor
- Boehringer Ingelheim Pharma GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 5830
- Ischemic stroke with a brain lesion visualized by neuroimaging (either
brain Computed Tomography (CT) or Magnetic Resonance Image (MRI)).
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.
- 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
- 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.
- As evidenced by cardiac monitoring for = 20 hours with automated
rhythm detection, there is absence of AF > 6 minutes in duration5
(within a 20 hour period, either as single episode or cumulative time of
multiple episodes).
Further inclusion criteria apply.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3600
- Modified Rankin Scale of >4 at time of randomization or inability to
swallow medications.
- Major risk cardioembolic source of embolism 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) MI, i) valvular vegetations,
or j) infective endocarditis.
- Any indication that requires treatment with an anticoagulant as per
Investigator`s judgment.
- History of AF (unless it was due to reversible causes such as
hyperthyroidism or binge drinking, and has been permanently resolved).
- Other specific stroke etiology (i.e. cerebral arteritis or arterial
dissection, migraine with aura/vasospasm, drug abuse).
- Renal impairment with estimated CrCl (as calculated by Cockcroft-Gault
equation) <30mL/min at screening, or where Investigator expects CrCl
is likely to drop below 30mL/min during the course of the study.
Further exclusion criteria apply.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method