Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02239120
• Date of registration: 10/09/2014
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim
• 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)
• Date of first enrolment: November 27, 2014
• Target sample size: 5390
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02239120
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Czechia, Estonia, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Malaysia, Mexico, New Zealand, Peru, Poland, Portugal, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United States

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim

Key inclusion & exclusion 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.

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.



Age minimum: 18 Years
Age maximum: 150 Years
Gender: All

Health Condition(s) or Problem(s) studied

Secondary Prevention

Stroke

Intervention(s)

Drug: dabigatran etexilate

Drug: placebo to dabigatran etexilate

Drug: ASA 100 mg

Drug: placebo to ASA

Drug: optional ASA as comedication

Drug: placebo to optional ASA as comedication

Primary Outcome(s)

First Major Bleed (Adjudicated) [Time Frame: Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.]

Adjudicated Recurrent Stroke [Time Frame: From randomisation until full follow up period, approximately 43 months.]

Secondary Outcome(s)

Adjudicated Composite of Non-fatal Stroke, Non-fatal Myocardial Infarction, or Cardiovascular Death [Time Frame: From randomisation until full follow up period, up to 43 months]

Adjudicated Life-threatening Bleed [Time Frame: Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.]

Any Bleed (Investigator-reported) [Time Frame: Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.]

Adjudicated Fatal Bleed [Time Frame: Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.]

Disabling Stroke [Time Frame: From randomisation until full follow up period, up to 43 months]

Adjudicated Intracranial Hemorrhage [Time Frame: Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.]

Adjudicated Ischaemic Stroke [Time Frame: From randomisation until full follow up period, up to 43 months]

All-cause Death [Time Frame: From randomisation until full follow up period, up to 43 months]

Secondary ID(s)

2013-003444-24

1160.189

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/09/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02239120