Study of Antithrombotic Treatment After IntraCerebral Haemorrhage

Atrial Fibrillation Clinical Trial

— STATICH  

Official title:

Study of Antithrombotic Treatment After IntraCerebral Haemorrhage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03186729
• Other study ID #: Version/date 180315
• Status: Recruiting
• Phase: Phase 4
• Start date: July 1, 2018
• Est. completion date: June 2031

Study information

• Verified date: September 2022
• Source: Oslo University Hospital
• Contact: Torgeir Bruun Wyller, PhD
• Phone: 004791166682
• Email: t.b.wyller[@]medisin.uio.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Patients with spontaneous ICH have an increased risk of recurrent ICH and they also have an increased risk of ischaemic diseases. Around 40-50% of patients use, or have an indication, for antithrombotic drugs at the time of ICH. However, little is known about the benefits and harms of using antithrombotic drugs for prevention of ischaemic events in patients who have had an ICH.

There are only observational studies addressing this question. Because of the lack of randomised-controlled trials and the inconclusive findings of the observational studies, guidelines have variably endorsed both starting and avoiding antithrombotic drugs after ICH.

The investigators therefore want to study the effect and safety of using antithrombotic drugs after ICH. Furthermore, since findings on MRI can be biomarkers for subsequent bleeding, there will also be performed a sub-study of the association between such findings on MRI and risk of recurrent ICH during treatment with antithrombotic drugs.

Patients with ICH during the last 6 months and with an indication for antithrombotic drugs will be included. Patients with vascular disease and indication for antiplatelet drugs will be randomised to antiplatelet treatment vs. no antithrombotic treatment. Patients with atrial fibrillation and indication for anticoagulant treatment will be randomised to anticoagulant treatment vs. no anticoagulant treatment. The follow up period is 2 years, and the primary effect variable is new ICH. The investigators will also assess new intracranial haemorrhage, extracranial haemorrhage and ischemic events, and functional and cognitive outcome.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 2031
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anticoagulant-Induced Bleeding
• Atrial Fibrillation
• Cerebral Hemorrhage
• Hemorrhage
• Intracranial Hemorrhages
• Secondary Prevention

Intervention

Drug:
• Antithrombotic Agent
Anticoagulant or antiplatelet drugs

Locations

Country	Name	City	State
Denmark	Herlev Gentofte Hospital	Copenhagen
Norway	Oslo University Hospital	Oslo
Sweden	Umeå University Hospital	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Countries where clinical trial is conducted

Denmark,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatal or non-fatal symptomatic ICH.	Neurological deterioration or death associated with intracerebral haemorrhage found on CT scan, MRI, or autopsy.	2 years
Secondary	Functional outcome	Modified Rankin Scale score	2 years
Secondary	Death of any cause	Death of any cause	2 years
Secondary	Vascular death	Death of vascular cause	2 years
Secondary	Symptomatic epidural, subdural, or subarachnoid haemorrhage	Neurological deterioration or death associated with epidural, subdural, or subarachnoid haemorrhage found on CT scan, MRI, or autopsy.	2 years
Secondary	Symptomatic major extracranial haemorrhage	Clinically overt bleeding associated with one or more of: Transfusion of >2 red cell units of blood; A fall in haemoglobin of 2 g/dL, (1.24 mmol/L); Bleeding into retroperitoneum, intraocular space or major joint; Bleeding leading to permanent treatment cessation	2 years
Secondary	Ischaemic events	Transient ischaemic attack, ischaemic stroke, unstable angina, acute myocardial infarction (type 1), peripheral arterial occlusion, mesenteric ischaemia, retinal arterial occlusion, deep vein thrombosis or pulmonary embolism.	2 years
Secondary	Cognitive outcome at two years	Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)	2 years