Health Condition 1: null- Patients who had embolic stroke of undetermined source.
Conditions
Interventions
Intervention1: Dabigatran etexilate: 110 mg or 150 mg, oral b.i.d. for period of upto 36 months.
Control Intervention1: Acetylsalicylic acid: 100 mg oral q.d. for period of upto 36 months.
Sponsors
Boehringer Ingelheim India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age >= 60 years or: Age 50-59 years plus at least one of the following additional risk factors for stroke: a) Mild to moderate heart failure, i.e. NYHA Class b) Diabetes mellitus (either type 1 or type 2) c) Hypertension requiring medical treatment with antihypertensive medication d) Patent foramen ovale with no interventional occlusion planned e) Prior stroke or TIA (before index stroke) f) CHA2DS2-VASc score >= 3 2) Acute ischemic stroke with an anatomically appropriate brain lesion visualized by neuroimaging (either brain CT1 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: a. up to 3 months before randomization (mRS OR b. up to 6 months before randomization (mRS = 60 years plus at least one additional risk factor for recurrent stroke (see stroke risk factors a - f as outlined in Inclusion 1). 3) 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. 4) 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). 5) 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
Exclusion criteria: 1. Modified Rankin Scale of greated than 4 at time of randomization or inability to swallow medications. 2. 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 (less than 4weeks) MI, i. valvular vegetations, or j. infective endocarditis. 3. Any indication that requires treatment with an anticoagulant as per Investigators judgment. 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 or vasospasm, drug abuse). 6. Primary intracerebral hemorrhage on qualifying neuroimaging 7. Conditions associated with increased risk of bleeding such as a) Major surgery in the previous month (in which case the patient may be eligible when one month has passed) b) Planned major surgery or intervention in the next 3 months c) 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) d) 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 e) Hemorrhagic disorder or bleeding diathesis, e.g. history of thrombocytopenia or platelet count more than100,000 perml at screening, von Willebrand disease, hemophilia A or B or other hereditary bleeding disorder, history of prolonged bleeding after surgery or intervention. f) Fibrinolytic agents within 48 hours of study entry g) Uncontrolled hypertension Systolic Blood Pressure (SBP) greater than180mmHg and or Diastolic Blood Pressure (DBP) greater than100 mmHg) 8. History of symptomatic nontraumatic intracranial hemorrhage. 9. Renal impairment with estimated CrCl (as calculated by Cockcroft-Gault equation) Lesser than 30mL per min at screening, or where Investigator expects CrCl is likely to drop below 30mL per min during the course of the study. 10. History of hypersensitivity or known contraindication to DE or ASA. 11. Known requirement for treatment of a concomitant disease (i.e. other than the index ESUS stroke) with ASA (with the exception of optional concomitant medication as provided by the Sponsor for patients with coronary artery disease, clopidogrel, dipyridamole, dipyridamole plus ASA, prasugrel, ticagrelor or ticlopidine at Visit 1, known need for continuous dual antiplatelet therapy after randomization. 12. Known requirement for treatment with methotrexategreater than or equal to15mg/week systemic ketoconazole, itraconazole, posaconazole, cyclosporine, tacrolimus, dronedarone, rifampicin, phenytoin, carbamazepine, St. Johnâ??s Wort or anycytotoxic or myelosuppressive therapy. 13. Concomitant disease that increases the risk of an adverse reac
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first recurrent stroke (ischemic, hemorrhagic, or unspecified)Timepoint: Time to first recurrent stroke | — |
Secondary
| Measure | Time frame |
|---|---|
| Ischemic Stroke,Composite endpoint of nonfatal stroke,MI and CV death,Disabling stroke,death,CV death,Hemorrhagic stroke,TIA,Systemic embolism ,MI,VTE,CV hospitalization,Recurrent stroke or SE,Recurrent stroke or death,Net Clinical benefit as per composite clinical endpoint of disabling stroke,life-threatening bleed,VTE, MIand CV death,Composite of MIischemic stroke, VTE, or hospitalization,â?¢ Change in cognitive status from Visit 1 to end of treatment in all patients.Timepoint: Time of occurance | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Chile, Colombia, Germany, Hong Kong, Hungary, India, Italy, Japan, Mexico, New Zealand, Peru, Poland, Republic of Korea, Russian Federation, Serbia, Singapore, Slovakia, Sweden, Taiwan, Thailand, United States of America
Contacts
Public ContactDr Partha Gokhale
Boehringer Ingelheim India Pvt. Ltd
Outcome results
None listed