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)
Neuroscience - Stroke,
Sheila Smith, M
The purpose of this study is to demonstrate that dabigatran etexilate is superior to aspirin for the prevention of stroke recurrence in patients with embolic stroke of undetermined source.
Main Inclusion Criteria (not all are listed)
Patients aged >50 years after embolic stroke of undetermined source (ESUS) within the last three months (six months, if aged ≥ 60 years with additional risk factor) prior to randomization who are eligible for treatment with antithrombotic therapy (i.e. dabigatran etexilate / ASA).
ESUS, defined as follows:
- Non-lacunar ischemic stroke detected by Computed Tomography (CT) or Magnetic Resonance Image (MRI)
- Absence of extracranial/intracranial atherosclerosis causing ≥50% luminal stenosis in artery supplying the area of recent brain ischemia.
- No major-risk cardioembolic source of embolism
- No other specific cause of stroke identified (e.g. cerebral arteritis, arterial dissection migraine with aura/vasospasm, drug abuse)
Main Exclusion criteria (not all are listed)
1. Requires frequent supervision or unable to swallow medications.
2. Major risk cardioembolic source of embolism
3. Any indication that requires treatment with an anticoagulant as per Investigator`s
4. History of AF (unless it was due to reversible causes such as hyperthyroidism or
binge drinking, and has been permanently resolved).
5. Other specific stroke etiology (i.e. cerebral arteritis or arterial dissection, migraine
with aura/vasospasm, drug abuse).
6. Primary intracerebral hemorrhage on qualifying neuroimaging
7. Conditions associated with increased risk of bleeding
8. History of symptomatic nontraumatic intracranial hemorrhage.
9. History of hypersensitivity or known contraindication to DE or ASA.
10. Requires aspirin for treatment of a concomitant disease than the index ESUS stroke (with the exception of optional concomitant medication as provided by the Sponsor for patients with coronary artery disease)
11. Any recent malignancy or radiation therapy (≤ 6 months) unless the malignancy was a basal cell carcinoma that was completely removed.
12. Pre-menopausal women who are not practicing and do not intend to practice an acceptable method of birth control throughout the study and/or do not agree to adhere to pregnancy testing required by this protocol.
13. Patients currently participating in another trial or who have participated in another trial with an investigational drug or device within the past 14 days preceding the screening.
14. Any condition the Investigator believes would not allow safe participation in the
study, e.g. other neurological condition that would complicate assessment of
outcomes (e.g. severe dementia).
15. Active liver disease