MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The present trial is addressing the question if a biologically distinct subgroup of ischemic stroke patients without known atrial fibrillation at admission, selected by a cut-off level of MRproANP concentration, which represents a underlying increased risk of cardiac thrombogenicity, benefits from direct oral anticoagulation (DOAC) versus antiplatelets as preventive treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Zurich
• Collaborator: Swiss National Science Foundation
• Treatments: Apixaban; Aspirin; Clopidogrel; Dabigatran; Edoxaban; Rivaroxaban

Criteria

Inclusion Criteria:

• Clinical diagnosis of ischemic stroke

• elevated MRproANP level within 24 hours from symptom onset

• Age ≥ 18 years

• Signed informed consent

Exclusion Criteria:

• History of AF, AF on 12-lead ECG on admission or any AF ≥30 seconds during heart-rhythm monitoring prior to randomization

• Other condition that require anticoagulant therapy (e.g., venous thromboembolism) as per Investigator's judgment including therapeutical dose of low-molecular-weight heparin or heparin

• Strong likelihood to be treated with prolonged (i.e. more than 30 days) dual antiplatelet therapy during the course of the trial (such as coronary stenting, etc.)

• Patients undergoing planned procedures where therapy with a DOAC is a contraindication (e.g. surgery)

• Previous intracranial hemorrhage in the last year

• Evidence of severe cerebral amyloid angiopathy if MRI scan performed

• Chronic kidney disease with creatinin clearance <30ml/min and or subject who requires haemodialysis or peritoneal dialysis

• Known bleeding diathesis (e.g. active peptic ulcer disease , platelet count < 100'000/mm3 or haemoglobin < 9 g/dl or INR ≥ 1.7, documented haemorrhagic tendencies or blood dyscrasias)

• Active infective endocarditis

• CT or MRI evidence of cerebral vasculitis

• Known allergy or intolerance to antiplatelets or DOACs

• Female who is pregnant or lactating or has a positive pregnancy test at time of admission

• Current participation in another drug trial