RESTART

• Conditions: Spontaneous Intracerebral Haemorrhage (ICH); MedDRA version: 14.1Level: LLTClassification code 10022753Term: Intracerebral haemorrhageSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-003190-26-GB
• Lead Sponsor: ACCORD (Academic and Clinical Central Office for Research & Development)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-26
• Last Update Posted: 28 January 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 720

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)
oeither ‘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

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.

Study & Design

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