Spontaneous Intracerebral Haemorrhage (ICH) MedDRA version: 14.1 Level: LLT Classification code 10022753 Term: Intracerebral haemorrhage System Organ Class: 100000004852
Conditions
Interventions
Product Name: Aspirin
Pharmaceutical Form:
Product Name: Dipyridamole
Pharmaceutical Form:
Product Name: Clopidogrel
Pharmaceutical Form:
Sponsors
ACCORD (Academic and Clinical Central Office for Research & Development)
ACCORD (Academic and Clinical Central Office for Research & Development)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient age =18 years. 2. Spontaneous ICH o not attributable to preceding traumatic brain injury, on the basis of: ? a history from the patient/witness of spontaneous symptom onset without preceding head trauma (head trauma occurring subsequent to ICH symptom onset is permissible) ? brain imaging appearances consistent with spontaneous ICH (which may be accompanied by the brain/bone/soft tissue appearances of trauma occurring subsequently) o either ‘secondary’ to an underlying structural cause (e.g. aneurysm, tumour, arteriovenous malformation, or intracranial venous thrombosis), or ‘primary’ (if the investigator either does not suspect an underlying structural cause, or it is not detected by further radiographic investigation).1,44 3. Patient had taken an antithrombotic (i.e. anticoagulant or antiplatelet) drug for the prevention of vaso-occlusive disease for any length of time before the onset of the qualifying ICH. 4. Patient is approaching the end of their hospital admission/assessment for the qualifying ICH. 5. Patient and their doctor are both uncertain about whether to start or avoid antiplatelet drugs. 6. Patient is registered with a general practitioner (GP). 7. Brain imaging study that first diagnosed the qualifying ICH is available. 8. Consent to randomisation from the patient (or personal / legal / professional representative if the patient does not have mental capacity). 9. If eligible for the brain MRI sub-study, the MRI must be performed after the ICH but before randomisation. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 470
Exclusion criteria
Exclusion criteria: 1. ICH due to traumatic brain injury, in the opinion of the investigator. 2. ICH due to haemorrhagic transformation of an ischaemic stroke, in the opinion of the investigator. 3. Patient is pregnant, breastfeeding, or of childbearing age and not taking contraception. 4. Patient is being treated or followed up in another CTIMP. 5. Patient and carer unable to understand spoken or written English (and local translator is not available). 6. Patients are ineligible for the brain MRI sub-study if they are claustrophobic or they have a contraindication to MRI.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: For adults surviving spontaneous (non-traumatic) intracerebral haemorrhage (ICH) who had taken an antithrombotic (i.e. anticoagulant or antiplatelet) drug for the prevention of vaso-occlusive disease before the ICH, does a policy of starting antiplatelet therapy result in a beneficial net reduction of all serious vascular events over two years compared with a policy of avoiding antiplatelet therapy? The primary objective of the pilot phase is to estimate, when all participants have completed at least two years of follow-up, the relative and absolute effects of antiplatelet drugs on the risk of brain haemorrhage happening again associated with a policy of starting antiplatelet drugs after the acute phase of brain haemorrhage. Ultimately, we want to determine whether antiplatelet drugs are beneficial for patients after brain haemorrhage because the gains from prevention of clotting problems outweigh the risks of bleeding at any site. This pilot phase of the trial may roll seamlessly i;Secondary Objective: To determine whether patients with tiny deposits of blood in the brain called 'microbleeds' on brain magnetic resonance imaging (MRI) have an increased risk of having a recurrent brain haemorrhage if prescribed antiplatelet drugs following a brain haemorrhage.;Primary end point(s): Fatal or non-fatal radiographically- or pathologically-proven recurrent symptomatic intracerebral haemorrhage (ICH). We define ICH as the abrupt onset of headache, altered level of consciousness, or focal neurological deficit, anatomically referable to a focal collection of blood predominantly located within the brain parenchyma (diagnosed on brain imaging or at autopsy), which was not attributable to prior trauma or haemorrhagic transformation of an ischaemic stroke. This also applies when neurological deterioration occurs with radiographic or pathological evidence of ICH volume growth early after the qualifying ICH (due to either haematoma expansion or re-bleeding).;Tim | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): A. Fatal events (i.e. followed by death within 30 days): 1. Complication of qualifying ICH (a) Neurological deterioration (e.g. hydrocephalus or perihaematomal oedema) (b) Non-neurological complications (e.g. pneumonia) 2. Symptomatic extradural haemorrhage, subdural haemorrhage, subarachnoid haemorrhage, or intraventricular haemorrhage (not accompanying spontaneous ICH) 3. Symptomatic major extracranial haemorrhage, sub-divided by site (requiring transfusion or endoscopic treatment or surgery, or resulting in death within 30 days) 4. Symptomatic vaso-occlusive events: transient ischaemic attack, ischaemic stroke, unstable angina (www.outcomes-umassmed.org/grace/Files/Standard_Definitions.pdf), acute spontaneous myocardial infarction (type 1),40 peripheral arterial occlusion, mesenteric ischaemia, retinal arterial occlusion, deep vein thrombosis or pulmonary embolism. 5. Cardiac death with symptoms suggestive of myocardial ischaemia (type 3),40 or evidence of arrhythmia 6. Deaths from any other known cause 7. Rapidly fatal stroke, consistent with the clinical manifestations of ICH, but without radiographic or pathological confirmation 8. Unwitnessed deaths without a clear cause and without further investigation B. Non-fatal events (i.e. not followed by death within 30 days): 1. Symptomatic extradural haemorrhage, subdural haemorrhage, subarachnoid haemorrhage, or intraventricular haemorrhage (not accompanying spontaneous ICH) 2. Symptomatic major extracranial haemorrhage, sub-divided by site (requiring transfusion or endoscopic treatment or surgery) 3. Symptomatic vaso-occlusive events: transient ischaemic attack, ischaemic stroke, unstable angina, myocardial infarction, peripheral arterial occlusion, mesenteric ischaemia, retinal arterial occlusion, deep vein thrombosis or pulmonary embolism. 4. Non-fatal stroke, with brain imaging performed too late to distinguish ICH from cerebral infarction 5. Annual ratings of participant function com | — |
Countries
United Kingdom
Contacts
Public ContactDr Rustam Al-Shahi Salman
University of Edinburgh
Outcome results
None listed