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

Phase 1

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: 19.1Level: PTClassification code 10067167Term: Cerebellar embolismSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.1Level: PTClassification code 10014498Term: Embolic strokeSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.1Level: PTClassification code 10060839Term: Embolic cerebral infarctionSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.1Level: PTClassification code 10074422Term: Brain stem embolismSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2013-003444-24-CZ

Lead Sponsor: Boehringer Ingelheim RCV GmbH & Co KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 6750

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 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

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 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.