Is intensive blood thinning with three antiplatelet drugs better than the current guideline treatment in reducing recurrence after acute stroke?

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 4100

Inclusion Criteria

Adults at high risk of recurrent ischaemic stroke:
1.Acute high risk TIAs <48 hours of onset All TIAs must have limb weakness and/or dysphasia lasting at least 10 minutes.
2.Ischaemic, non cardioembolic stroke with limb weakness, dysphasia or hemianopia =48 hours of onset with neuroimaging to rule out alternative causes.
3.Meaningful consent, or consent from a relative, carer or legal representative if the patient is unable to give consent (e.g. in cases of dysphasia, confusion, or reduced conscious level).

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 1435
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2665

Exclusion Criteria

1.Age<50
2.Isolated sensory symptoms or vertigo/dizziness or facial weakness
3.Isolated hemianopia without positive neuroimaging evidence
4.Intracranial haemorrhage
5.Baseline neuroimaging showing parenchymal haemorrhagic transformation (PH I/II) of infarct, subarachnoid haemorrhage or other non ischaemic cause for symptoms
6.Presumed cardioembolic stroke (e.g. history or current AF, myocardial infarction within 3 months)
7.Participants with contraindications to, or intolerance of, aspirin, clopidogrel or dipyridamole.
8.Participants with definite need for treatment with aspirin, clopidogrel or dipyridamole individually or in combination (e.g. aspirin and clopidogrel for recent MI/acute coronary syndrome)
9.Participant has taken clopidogrel or dipyridamole after the index event but prior to randomisation (aspirin is allowed between ictus onset and randomisation)
10.Definite need for full dose oral (e.g. warfarin, dabigatran) or medium to high dose parenteral (e.g. heparin) anti-coagulation. NB Low dose heparin for DVT prophylaxis is allowed
11.Definite need for glycoprotein IIb-IIIa inhibitors
12.Received thrombolysis within the last 24 hours
13.No enteral access
14.Pre-morbid dependency (mRS>2).
15.Severe high BP (BP>185/110 mmHg).
16.Haemoglobin less than 10g/dL
17.Platelet count more than 600 x 109 /L or less than 100 x 109 /L
18.White cell count more than 30 x 109 /L or less than 3.5 x 109 /L
19.Major bleeding within 1 year (e.g. peptic ulcer, intracerebral haemorrhage).
20.Planned surgery during 3 month follow-up (e.g. carotid endarterectomy)
21.Concomitant STEMI or NSTEMI.
22.Stroke secondary to a procedure (e.g. carotid or coronary intervention)
23.Coma (GCS<8)
24.Non-stroke life expectancy<6 months
25.Dementia
26.Participation in another drug or devices trial concurrently or within 30 days. (participants may take part in observational studies or non-drug or devices trials)
27.Geographical or other factors that may interfere with follow-up e.g. no fixed address or telephone contact number, not registered with a GP, or overseas visitor.
28.Females of childbearing potential, pregnancy or breastfeeding

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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