Study of Antithrombotic Treatment After IntraCerebral Haemorrhage

• Register: ClinicalTrials.gov
• Last refreshed on: 3 October 2022
• Main ID: NCT03186729
• Date of registration: 08/06/2017
• Prospective Registration: Yes
• Primary sponsor: Oslo University Hospital
• Public title: Study of Antithrombotic Treatment After IntraCerebral Haemorrhage STATICH
• Scientific title: Study of Antithrombotic Treatment After IntraCerebral Haemorrhage
• Date of first enrolment: July 1, 2018
• Target sample size: 500
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03186729
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Denmark, Norway, Sweden

Contacts

• Name: Torgeir Bruun Wyller, PhD
• Affiliation: Oslo University Hospital

• Name: Torgeir Bruun Wyller, PhD

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Atrial Fibrillation

Cerebral Hemorrhage

Anticoagulant-Induced Bleeding

Secondary Prevention

Intracranial Hemorrhages

Intervention(s)

Drug: Antithrombotic Agent

Primary Outcome(s)

Fatal or non-fatal symptomatic ICH. [Time Frame: 2 years]

Secondary Outcome(s)

Cognitive outcome at two years [Time Frame: 2 years]

Vascular death [Time Frame: 2 years]

Symptomatic major extracranial haemorrhage [Time Frame: 2 years]

Ischaemic events [Time Frame: 2 years]

Functional outcome [Time Frame: 2 years]

Death of any cause [Time Frame: 2 years]

Symptomatic epidural, subdural, or subarachnoid haemorrhage [Time Frame: 2 years]

Secondary ID(s)

Version/date 180315

Source(s) of Monetary Support

Please refer to primary and secondary sponsors