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)

  • STATUS
    Recruiting
  • sponsor
    Boehringer Ingelheim
Updated on 25 March 2021

Summary

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)

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).

Details
Clinical Study IdentifierTX140519
SponsorBoehringer Ingelheim
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age greater than or equal to 60 years or
Age 50 to 59 years plus at least one of the following additional risk factors for stroke
Mild to moderate heart failure, i.e. New York Heart Association (NYHA) Class < = 3 with left ventricular ejection fraction < / = 40% as documented by e.g. echocardiogram, radionuclide or contrast angiogram in the last 6 months
Diabetes mellitus (either type 1 or type 2)
Hypertension requiring medical treatment with antihypertensive medication
Patent foramen ovale with no interventional occlusion planned
Prior stroke or Transient Ischemic Attach (TIA) (before index stroke)
CHA2DS2-VASc (Congestive heart failure, Hypertension, Age > = 75, Diabetes, prior Stroke/Transient Ischemic Attack) score > = 3
Acute ischemic stroke with an anatomically appropriate brain lesion visualized by neuroimaging (either brain CT or MRI). The visualized stroke is non-lacunar infarct, i.e. involving the cortex or > 1.5 cm ( > 2.0 cm if measured on MRI diffusion-weighted images) in largest diameter if exclusively subcortical. It 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 (see stroke risk factors a - f as outlined in Inclusion 1)
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 > = 24 hours with automated rhythm detection, there is absence of atrial fibrillation (AF) > 6 minutes in duration (within a 24 hour period, either as single episode or cumulative time of multiple episodes)
The patient must give informed consent in accordance with International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines and local legislation and/or regulations

Exclusion Criteria

Modified Rankin Scale of > = 4 at time of rand. or inability to swallow medications
Major risk cardioembolic source of embolism such as
intracardiac thrombus as evidenced by transthoracic or transesophageal echocardiography
paroxysmal, persistent or permanent AF
atrial flutter
prosthetic cardiac valve (mitral or aortic, bioprosthetic or mechanical)
atrial myxoma
other cardiac tumors
moderate or severe mitral stenosis
recent ( < 4weeks) MI
valvular vegetations, or
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 and has been permanently resolved)
Other specific stroke etiology (i.e. cerebral arteritis or arterial dissection, migraine with aura/vasospasm, drug abuse)
Primary intracerebral hemorrhage on qualifying neuroimaging
Conditions associated with increased risk of bleeding such as
Major surgery in the previous month (in which case the patient may be eligible when one month has passed)
Planned major surgery or intervention in the next 3 months
History of intraocular, spinal, retroperitoneal or atraumatic intra-articular bleeding unless the causative factor has been permanently eliminated or repaired per Investigator judgment (e.g. by surgery)
Gastrointestinal hemorrhage within the past six months unless the cause has been permanently eliminated or repaired per Investigator judgment (e.g. by surgery), or endoscopically documented gastroduodenal ulcer disease in the previous 30 days
Hemorrhagic disorder or bleeding diathesis, e.g. history of thrombocytopenia or platelet count <100,000/ml at screening, von Willebrand disease, hemophilia A or B or other hereditary bleeding disorder, history of prolonged bleeding after surgery/intervention
Fibrinolytic agents within 48 hours of study entry
Uncontrolled hypertension Systolic Blood Pressure (SBP) >180mmHg and/or Diastolic Blood Pressure (DBP) >100 mmHg)
History of symptomatic nontraumatic intracranial hemorrhage
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
History of hypersensitivity or known contraindication to dabigatran etexilate (DE or ASA
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