Clinical Trial Details

Overview

Research Study 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)

Purpose

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).

To Learn more

CW ID: 206957
Date Last Changed: March 8, 2016

Clinical Trial Snapshot

Phase
3
Gender
Both Male and Female
Age
N/A
Overall Status
Recruiting
Lead Sponsor
Boehringer Ingelheim
Duration
50 Years
Facility Type
Out-Patient

Eligibility

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

Contact

Tara McTigue
University of South Florida- South Tampa Center for Advanced Healthcare
2 Tampa General Circle
Tampa, FL 33606
Phone: 813-259-0826

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