Created at Source Raw Value Validated value
March 19, 2021, 12:31 a.m. usa

- known hypersensitivity to trial medication (patient will be excluded from specific arm). - long-term pre-hospital administration of trial medication (patient will be excluded from specific arm). - previous medical history of significant complication with trial medication or trial medication drug class. - medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he/she were to participate in the trial. - participant not expected to survive 14 days from hospital discharge. the presence of any of the following will preclude participant inclusion in the apixaban arm: - active clinically significant bleeding. - childs-pugh c, or worse, chronic liver disease - known pregnancy or breast-feeding - coagulopathy: inr greater than 1.7 or platelet count below 70 - lesion or condition considered by the investigator as a significant risk factor for major bleeding. this may include recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms, or major intraspinal or intracerebral vascular abnormalities. - concomitant treatment following discharge with any other anticoagulant agent, including but not limited to unfractionated heparin, low molecular weight heparins (e.g. enoxaparin, dalteparin), heparin derivatives (e.g. fondaparinux), and other oral anticoagulants (e.g. warfarin, rivaroxaban, dabigatran). the presence of any of the following will preclude participant inclusion in the atorvastatin arm: - childs-pugh c, or worse, chronic liver disease - unexplained persistent elevations of serum transaminases exceeding five times the upper limit of normal. - known pregnancy or breast-feeding. - treatment with the hepatitis c antivirals lecaprevir/pibrentasvir, ciclosporin or hiv protease inhibitors. - serum creatine kinase concentration exceeding 10 times the upper limit of normal.

- known hypersensitivity to trial medication (patient will be excluded from specific arm). - long-term pre-hospital administration of trial medication (patient will be excluded from specific arm). - previous medical history of significant complication with trial medication or trial medication drug class. - medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he/she were to participate in the trial. - participant not expected to survive 14 days from hospital discharge. the presence of any of the following will preclude participant inclusion in the apixaban arm: - active clinically significant bleeding. - childs-pugh c, or worse, chronic liver disease - known pregnancy or breast-feeding - coagulopathy: inr greater than 1.7 or platelet count below 70 - lesion or condition considered by the investigator as a significant risk factor for major bleeding. this may include recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms, or major intraspinal or intracerebral vascular abnormalities. - concomitant treatment following discharge with any other anticoagulant agent, including but not limited to unfractionated heparin, low molecular weight heparins (e.g. enoxaparin, dalteparin), heparin derivatives (e.g. fondaparinux), and other oral anticoagulants (e.g. warfarin, rivaroxaban, dabigatran). the presence of any of the following will preclude participant inclusion in the atorvastatin arm: - childs-pugh c, or worse, chronic liver disease - unexplained persistent elevations of serum transaminases exceeding five times the upper limit of normal. - known pregnancy or breast-feeding. - treatment with the hepatitis c antivirals lecaprevir/pibrentasvir, ciclosporin or hiv protease inhibitors. - serum creatine kinase concentration exceeding 10 times the upper limit of normal.