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TerminatedPhase 4

Study of Antithrombotic Treatment After IntraCerebral Haemorrhage

Reason given: Lack of resources

Key facts

Phase
Phase 4

This trial has no sites in United States.

It has sites in 3 countries. Choose a country to see its sites.

Trial details

Who runs it
Oslo University Hospital
Trial code
NCT03186729
Record updated
12 February 2025
Original description
The study evaluates the effects of antithrombotic drugs (anticoagulant drugs or antiplatelet drugs) for prevention of ischaemic events in patients With recent intracerebral haemorrhage.Read full original descriptionShow less

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

Inclusion: 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: Contraindications to the antithrombotic drug that will be administered; Clear indication for antiplatelet or anticoagulant treatment (e.g. prosthetic heart valves); Malignancy with life expectancy less than 2 years; Patient is pregnant, breastfeeding, or of childbearing age and not taking contraception; For patients examined with MRI: Contraindication for brain MRI.

ClinicalTrials.gov NCT03186729