Study of Antithrombotic Treatment after Intracerebral Haemorrhage (STATICH)

Phase 1

• Conditions: Patients with spontaneous intracerebral haemorrhage (ICH) and indication for antithrombotic treatment for prevention of ischaemic events.; MedDRA version: 20.0Level: LLTClassification code 10007650Term: Cardiovascular disorder NOSSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-002636-13-DK
• Lead Sponsor: Oslo University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-07
• Last Update Posted: 23 July 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Patient age =18 years.
• Spontaneous, primary ICH, of =1 day, but not more than 180 days’ duration, 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 has 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, and waiver of consent is accepted in the patients country).
• CT or MRI (for patients in MRI sub-study) is performed before randomisation.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

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.See protocol for details
• For patients in MRI substudy: Contraindication for the brain MRI
• Malignancy With life expectancy less than 2 years

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study the effects of antithrombotic drugs given for prevention of ischaemic events after ICH.;Secondary Objective: To determine whether there is an interaction between the presence of brain microbleeds on MRI and the effects of antithrombotic drugs after ICH.;Primary end point(s): Fatal or non-fatal symptomatic ICH. ;Timepoint(s) of evaluation of this end point: At two years.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Functional outcome at two years (according to the modified Rankin Scale)<br>•Cognitive outcome at two years <br>•Death of any cause <br>•Vascular death<br>•Symptomatic epidural, subdural, or subarachnoid haemorrhage<br>•Symptomatic major extracranial haemorrhage <br>•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.<br>;Timepoint(s) of evaluation of this end point: At two years.