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Clinical Trials/EUCTR2007-006749-42-DK
EUCTR2007-006749-42-DKActive, not recruitingPhase 1

Safety and efficacy of clopidogrel when added to aspirin and dipyridamole in high risk patients with recent ischaemic stroke or TIA: a randomised controlled trial - TARDIS

niversity of Nottingham0 sites4,100 target enrollmentStarted: April 24, 2013Last updated:
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Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
4,100
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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

  • •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

Investigators

Sponsor
niversity of Nottingham

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