Apixaban versus antiplatelet drugs or no antithrombotic drugs after anticoagulation-associated intracerebral haemorrhage in patients with atrial fibrillation. A randomised phase II clinical trial.
Recruiting
- Conditions
- ApixbanIntracerebral haemorrhageAntiplatelet drugsAtrial fibrillationHersenbloedingPlaatjesremmersAtriumfibrilleren
- Registration Number
- NL-OMON27026
- Lead Sponsor
- MC Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
Intracerebral haemorrhage, documented with CT or MRI, during treatment with anticoagulation (VKA, any direct thrombin inhibitor, any factor Xa inhibitor, or (low-molecular-weight) heparin at a therapeutic dose).
- The haemorrhage has occurred between 7 and 90 days before randomization.
Exclusion Criteria
- Conditions other than atrial fibrillation for which the patient requires long-term anticoagulation.
- A different clinical indication for the use of an APD, such as clopidogrel for recent coronary stenting.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The combination of vascular death or non-fatal stroke (cerebral infarction, intracerebral haemorrhage, or subarachnoid haemorrhage) during follow-up.
- Secondary Outcome Measures
Name Time Method Vascular death. <br /><br>Death from any cause. <br /><br>All stroke <br /><br>Ischaemic stroke. <br /><br>Intracerebral haemorrhage. <br /><br>Other major extracranial haemorrhage<br /><br>Any intracranial haemorrhage other than ICH. <br /><br>Systemic embolism.<br /><br>Myocardial infarction. <br /><br>Functional outcome as assessed with the score on the modified Rankin Scale at 6 and 12 months; thereafter annually and at the end of the study.<br>