Apixaban for Treatment of Embolic Stroke of Undetermined Source (NCT02427126) | Clinical Trial Compass
CompletedPhase 3
Apixaban for Treatment of Embolic Stroke of Undetermined Source
Germany352 participantsStarted 2015-12
Plain-language summary
Multicentre (national, Germany), randomized (2x2 factorial), open, parallel group, active controlled, efficacy study (phase III)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria Must be ≥ 18 years at the time of signing the informed consent.
* ESUS must be defined according to following criteria:
* Stroke detected by CT or MRI that is not lacunar
* Absence of extracranial or intracranial atherosclerosis causing ≥50% luminal stenosis in arteries supplying the area of ischaemia
* No major-risk cardioembolic source of embolism
* No other specific cause of stroke identified
* \* At least one of the following non-major but suggestive risk factors for cardiac embolism:
* LA size \>45mm (parasternal axis)
* spontaneous echo contrast in LAA
* LAA flow velocity \<=0.2m/s
* atrial high rate episodes
* CHA2DS2-Vasc score \>=4
* persistent foramen ovale
* Understand and voluntarily sign an informed consent document
* Women of childbearing potential (WOCBP) must be using an adequate method of contraception.
Exclusion Criteria:
* History of hypersensitivity to the investigational medicinal product
* Participation in other clinical trials or observation period of competing trials.
* Arteria cerebri media stroke affecting \> 30% of c o r r e s p o n d i n g territory
* Diagnosis of haemorrhage or other pathology,
* Clear indication for anticoagulation
* Inability to control following risk factors for Hemorrhagic Transformation of fresh cerebral Infarction (HTI) during index hospital stay: presence of HTI at the time of anticoagulation, blood pressure \>140 mmHg systolic, abnormal blood glucose Clear indication for dual ant…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Imaging Endpoint: Occurrence of at least one new ischemic lesion at 12 months after study drug initiation when compared to baseline MRI before study drug initiation