Phase 3
N=5,390
Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS)
Stroke · Secondary Prevention
Bottom Line
View on ClinicalTrials.gov: NCT02239120 ↗Enrolled (actual)
5,390
Serious AEs
27.4%
Results posted
Sep 2019
Primary outcome: Primary: Adjudicated Recurrent Stroke — 4.09; 4.80 Annualised event rate (%/ year) — p=0.1028
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- optional ASA as comedication (Drug); placebo to ASA (Drug); placebo to optional ASA as comedication (Drug); placebo to dabigatran etexilate (Drug); ASA 100 mg (Drug); dabigatran etexilate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjudicated Recurrent Stroke |
4.09; 4.80 | 0.1028 |
| PRIMARY First Major Bleed (Adjudicated) |
1.84; 1.33 | 0.1076 |
| SECONDARY Adjudicated Ischaemic Stroke |
3.97; 4.71 | 0.0892 |
| SECONDARY Adjudicated Composite of Non-fatal Stroke, Non-fatal Myocardial Infarction, or Cardiovascular Death |
4.80; 5.40 | 0.1911 |
| SECONDARY Disabling Stroke |
0.55; 0.93 | 0.0354 sig |
| SECONDARY All-cause Death |
1.24; 1.28 | 0.8074 |
| SECONDARY Adjudicated Intracranial Hemorrhage |
0.67; 0.63 | 0.9064 |
| SECONDARY Adjudicated Fatal Bleed |
0.00; 0.05 | — |
| SECONDARY Adjudicated Life-threatening Bleed |
0.76; 0.91 | 0.4352 |
| SECONDARY Any Bleed (Investigator-reported) |
15.21; 11.64 | 0.0003 sig |
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).
Eligibility 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) = 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.
Data sourced from ClinicalTrials.gov (NCT02239120). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.