Apixban Intracerebral haemorrhage Antiplatelet drugs Atrial fibrillation Hersenbloeding Plaatjesremmers Atriumfibrilleren
Conditions
Interventions
Patients will be randomised between:
-apixaban 5 mg orally twice daily
-treatment with one or two oral APDs (acetylsalicylic acid, carbasalate calcium, clopidogrel, or dipyridamole) or no antithro
Sponsors
UMC Utrecht
Eligibility
Inclusion criteria
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. - Diagnosis of (paroxysmal) non-valvular AF, documented on electrocardiography. - A CHA2DS2VASc score ≥ 3. - Score on the modified Rankin scale (mRS) ≤4. - Equipoise regarding the optimal medical treatment for the prevention of stroke. The clinical equipoise should be self-reported by the attending neurologist after reviewing all relevant information available for the individual patient. - Age ≥ 18 years. - Written informed consent by the patient or by a legal representative
Exclusion criteria
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. - Rheumatic mitral valve disease, a prosthetic heart valve, or mitral valve repair. - Serious bleeding event in the previous 6 months, except for intracerebral haemorrhage. - High risk of bleeding (e.g., active peptic ulcer disease, a platelet count of <100,000.mL-1 or haemoglobin level of <6.206 mMol.L-1, ischemic stroke in the previous 7 days (patients are eligible thereafter), documented haemorrhagic tendencies, or blood dyscrasias). - Current alcohol or drug abuse. - Life expectancy of less than 1 year. - Severe renal insufficiency (a serum creatinine level of more than 221 μmol per liter or a calculated creatinine clearance of <25 ml per minute). - Alanine aminotransferase or aspartate aminotransferase level greater than 2 times the upper limit of the normal range or a total bilirubin more than 1.5 times the upper limit of the normal range, unless an benign causative factor, other than moderate or severe liver disease, (e.g. Gilbert’s syndrome) is known or identified. - Allergy to apixaban. - Use of strong cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp) inhibitors (e.g. systemic azole-antimycotics as ketoconazole or HIV protease inhibitors such as ritonavir). - Pregnancy or breastfeeding. - Women of childbearing potential: any woman who has begun menstruation and is not menopausal or otherwise permanently unable to conceive. A post-menopausal woman is defined as a woman who is over the age of 45 and has not had a menstrual period for at least 12 months.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Vascular death. Death from any cause. All stroke Ischaemic stroke. Intracerebral haemorrhage. Other major extracranial haemorrhage Any intracranial haemorrhage other than ICH. Systemic embolism. Myocardial infarction. 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. | — |
Primary
| Measure | Time frame |
|---|---|
| The combination of vascular death or non-fatal stroke (cerebral infarction, intracerebral haemorrhage, or subarachnoid haemorrhage) during follow-up. | — |
Contacts
Public ContactK.M. Nieuwenhuizen, van
University Medical Center Utrecht Brain Center Rudolf Magnus Department of Neurology & Neurosurgery G03.232 PO Box 85500
Outcome results
None listed