Study of Antithrombotic Treatment After IntraCerebral Haemorrhage

• Status: Recruiting
• Trial end date: 2031-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The study evaluates the effects of antithrombotic drugs (anticoagulant drugs or antiplatelet drugs) for prevention of ischaemic events in patients With recent intracerebral haemorrhage.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oslo University Hospital
• Treatments: Anticoagulants; Fibrinolytic Agents; Platelet Aggregation Inhibitors

Criteria

Inclusion Criteria:

• Patient age ≥18 years.

• Spontaneous, primary ICH, of ≥1 day, but not more than 180 days after onset of qualifying ICH, i.e.:

• No preceding traumatic brain injury, based on history from the patient/witness of spontaneous symptom onset, and brain imaging appearances consistent of spontaneous ICH (i.e. any brain/bone/soft tissue appearances of trauma must have occurred secondary to a spontaneous ICH)

• No 'secondary' or underlying structural cause (e.g. haemorrhagic transformation of an ischaemic stroke, aneurysm, tumour, arteriovenous malformation, or intracerebral venous thrombosis)

• Patient have indication for antithrombotic (i.e. anticoagulant or antiplatelet) drug for the prevention of ischaemic events, either antiplatelet drugs (for patients with vascular disease), or anticoagulant drug for patients with atrial fibrillation.

• Consent to randomisation from the patient (or personal / legal / professional representative if the patient does not have mental capacity).

• MRI (or CT) is performed before randomisation.

Exclusion Criteria:

• Clear indication for antiplatelet or anticoagulant treatment (e.g. prosthetic heart valves).

• Contraindications to the antithrombotic drug that will be administered.

• Patient is pregnant, breastfeeding, or of childbearing age and not taking contraception.

• For patients examined with MRI: Contraindication for brain MRI

• Malignancy with life expectancy less than 2 years