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: 18.1 Level: PT Classification code 10067167 Term: Cerebellar embolism System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.1
Conditions
Interventions
Trade Name: Pradaxa
Product Name: dabigatran etexilate 110 mg
Product Code: BIBR1048MS
Pharmaceutical Form: Capsule, hard
INN or Propose
Sponsors
Unilfarma - União Internacional de Lab. Farmacêuticos, Lda.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age greater than or equal to 60 years or: Age 18 to 59 years plus at least one of the following additional risk factors for stroke: a) Mild to moderate heart failure, i.e. New York Heart Association (NYHA) Class =75, Diabetes, prior Stroke/Transient Ischemic Attack) score >= 3 2) 2a) Ischemic stroke with a brain lesion visualized by neuroimaging (eIther brain CT or 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. 2b) The index stroke must have occurred either: a. up to 3 months before randomization (Modified Rankin Scale (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 transcranial doppler (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 atrial fibrillation (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. 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
Exclusion criteria: 1. Modified Rankin Scale of >=4 at time of rand. 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 (180mmHg and/or Diastolic Blood Pressure (DBP) >100 mmHg) h) Any history of intracranial aneurysm (unless it was permanently resolved with either clipping or coiling at least one year prior to the study entry) 8. History of symptomatic nontraumatic intracranial hemorrhage with risk of recurrence according to Investigator judgment 9. 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. 10. History of hypersensitivity or known contraindication to dabigatran etexilate (DE) or ASA. Further exclusion criteria apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of dabigatran etexilate (110 mg b.i.d. or 150 mg b.i.d., with dosing according to age and renal function), to ASA (100 mg once daily) for the prevention of stroke recurrence in patients with embolic stroke of undetermined source.;Secondary Objective: The trial will also characterize the safety of dabigatran etexilate in this setting.;Primary end point(s): Time to first recurrent stroke (ischemic, hemorrhagic, or unspecified);Timepoint(s) of evaluation of this end point: up to 36 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1: Time to first major bleed 2: Time to Ischemic Stroke 3: Composite endpoint of (time to) nonfatal stroke, nonfatal myocardial infarction (MI) and cardiovascular death 4: Time to Disabling stroke (modified Rankin Scale greater than or equal to 4, as determined 3 months after recurrent stroke) 5: Time to All-cause death 6: Time to first intracranial hemorrhage 7: Time to life-threatening bleed 8: Fatal bleed 9: Time to any bleed (all severities) ; Timepoint(s) of evaluation of this end point: 1: up to 36 months 2: up to 36 months 3: up to 36 months 4: up to 36 months 5: up to 36 months 6: up to 36 months 7: up to 36 months 8: up to 36 months 9: up to 36 months | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Estonia, European Union, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Korea, Republic of, Mexico, New Zealand, Peru, Poland, Portugal, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, United States
Contacts
Public ContactQRPE pSC CT Information Disclosure
Boehringer Ingelheim International GmbH
Outcome results
None listed