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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02239120




Registration number
NCT02239120
Ethics application status
Date submitted
10/09/2014
Date registered
12/09/2014
Date last updated
6/09/2019

Titles & IDs
Public title
Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS)
Scientific title
Randomized, Double-blind, Evaluation in Secondary Stroke Prevention Comparing the EfficaCy and Safety of the Oral Thrombin Inhibitor Dabigatran Etexilate (110 mg or 150 mg, Oral b.i.d.) Versus Acetylsalicylic Acid (100 mg Oral q.d.) in Patients With Embolic Stroke of Undetermined Source (RESPECT ESUS)
Secondary ID [1] 0 0
2013-003444-24
Secondary ID [2] 0 0
1160.189
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 0 0
Secondary Prevention 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - optional ASA as comedication
Treatment: Drugs - placebo to ASA
Treatment: Drugs - placebo to optional ASA as comedication
Treatment: Drugs - placebo to dabigatran etexilate
Treatment: Drugs - ASA 100 mg
Treatment: Drugs - dabigatran etexilate

Experimental: dabigatran etexilate 110 or 150 mg - Patients will be assigned Dabigatran 150 mg b.i.d. (unless they are 75 years or older, or have a Creatinine Clearance (CrCl) of greater than or equal to 30 to less than 50ml/min (or experience GI bleed during trial), in which case they will receive Dabigatran 110 mg b.i.d.). All patients in this arm will also receive ASA placebo (q.d.)

Active Comparator: ASA 100 mg - All patients will receive blinded ASA 100 mg q.d. and dabigatran placebo 150 mg b.i.d. (unless they are 75 years or older, or have a CrCl of greater than or equal to 30 to less than 50ml/min (or experience GI bleed during trial), in which case they will receive placebo Dabigatran 110 mg b.i.d


Treatment: Drugs: optional ASA as comedication
optional concomitant treatment which can be used for patients with coronary artery disease. It is not required for these pts.

Treatment: Drugs: placebo to ASA
placebo to comparator drug

Treatment: Drugs: placebo to optional ASA as comedication
optional concomitant treatment which can be used for patients with coronary artery disease. It is not required for these pts.

Treatment: Drugs: placebo to dabigatran etexilate
placebo

Treatment: Drugs: ASA 100 mg
active comparator drug

Treatment: Drugs: dabigatran etexilate
active drug
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adjudicated Recurrent Stroke
Timepoint [1] 0 0
From randomisation until full follow up period, approximately 43 months.
Primary outcome [2] 0 0
First Major Bleed (Adjudicated)
Timepoint [2] 0 0
Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.
Secondary outcome [1] 0 0
Adjudicated Ischaemic Stroke
Timepoint [1] 0 0
From randomisation until full follow up period, up to 43 months
Secondary outcome [2] 0 0
Adjudicated Composite of Non-fatal Stroke, Non-fatal Myocardial Infarction, or Cardiovascular Death
Timepoint [2] 0 0
From randomisation until full follow up period, up to 43 months
Secondary outcome [3] 0 0
Disabling Stroke
Timepoint [3] 0 0
From randomisation until full follow up period, up to 43 months
Secondary outcome [4] 0 0
All-cause Death
Timepoint [4] 0 0
From randomisation until full follow up period, up to 43 months
Secondary outcome [5] 0 0
Adjudicated Intracranial Hemorrhage
Timepoint [5] 0 0
Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.
Secondary outcome [6] 0 0
Adjudicated Fatal Bleed
Timepoint [6] 0 0
Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.
Secondary outcome [7] 0 0
Adjudicated Life-threatening Bleed
Timepoint [7] 0 0
Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.
Secondary outcome [8] 0 0
Any Bleed (Investigator-reported)
Timepoint [8] 0 0
Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.

Eligibility
Key inclusion criteria
Inclusion criteria:

- 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 Transcranial Doppler (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 duration (within a 20 hour period, either as
single episode or cumulative time of multiple episodes).

Further inclusion criteria apply.
Minimum age
18 Years
Maximum age
150 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- 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 Atrial fibrillation (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.

- Any indication that requires treatment with an anticoagulant as per Investigator's
judgment.

- History of atrial fibrillation (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 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.

Further exclusion criteria apply.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/11/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/08/2018
Sample size
Target
Accrual to date
Final
5390
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
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St Vincent's Hospital Sydney - Darlinghurst
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Kanwal Medical Complex - Kanwal
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John Hunter Hospital - New Lambton
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Royal North Shore Hospital - St Leonards
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Sunshine Coast University Hospital - Birtinya
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Royal Brisbane and Women's Hospital - Herston
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Royal Adelaide Hospital - Adelaide
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Calvary North Adelaide Hospital - Adelaide
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Box Hill Hospital - Box Hill
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Austin Health - Heidelberg
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Royal Melbourne Hospital - Parkville
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Alfred Health - Victoria
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2050 - Camperdown
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2010 - Darlinghurst
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2259 - Kanwal
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2305 - New Lambton
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2038 - St Leonards
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4575 - Birtinya
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4029 - Herston
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5000 - Adelaide
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5001 - Adelaide
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3128 - Box Hill
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3084 - Heidelberg
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3050 - Parkville
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3004 - Victoria
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Zhytomyr

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT02239120
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02239120