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ISRCTN
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ISRCTN83673558
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ClinicalTrials.gov identifier
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Public title
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Combined aspirin, clopidogrel and dipyridamole versus aspirin alone in stroke secondary prevention: a safety, tolerability and feasibility study
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Scientific title
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Acronym
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Triple 2
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Serial number at source
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N/A
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Study hypothesis
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We hypothesise that combination therapy with three antiplatelet agents that act through different mechanisms may maximise the benefit of antiplatelet treatment in the secondary prevention of stroke, both in patients with sinus rhythm and those with stroke who cannot be anticoagulated.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Ischaemic stroke
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Participants - inclusion criteria
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1. Aged 18 years or older
2. Ischaemic stroke on computed tomography (CT)/magnetic resonance imaging (MRI) within 5 years
3. Previous transient ischemic attack (TIA) within 5 years
4. Written informed consent from patient
5. In sinus ryhthm or atrial fibrillation but not suitable for anticoagulation
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Participants - exclusion criteria
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1. Thrombocytopenia
2. Severe hypertension
3. Previous cerebral haemorrhage
4. Hypersensitivity or intolerance to aspirin, dipyridamole or clopidogrel
5. Any history of peptic ulcer or gastrointestinal bleeding
6. Severe concomitant medical conditions including acquired immunodeficiency syndrome (AIDS) or cancer
7. Pregnancy or breast feeding
8. Patients needing or already receiving anticoagulant or non-steroidal anti-inflammatory drugs (NSAIDs) other than aspirin therapy
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Anticipated start date
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26/10/2001
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Anticipated end date
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28/02/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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51
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Interventions
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Combined aspirin (75 mg once a day [od], A), dipyridamole (200 mg twice a day [bd], B) and clopidogrel (75 mg od, C) versus aspirin (75 mg od, A) alone.
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Primary outcome measure(s)
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Number of subjects completing randomised treatment to final follow up.
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Secondary outcome measure(s)
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1. Recurrent ischaemic stroke or TIA
2. Intracerebral haemorrhage
3. Major extracranial bleeding
4. Minor extracranial bleeding (epistaxis, purpura)
5. Sitting and standing blood pressure (BP), heart rate at 2 weeks, 3 months and follow up
6. Presence of headache
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Sources of funding
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University of Nottingham (UK)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/18682741
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Contact name
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Prof
Philip
Bath
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Address
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Division of Stroke Medicine
Clinical Sciences Building
City Hospital Campus
Hucknall Road
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City/town
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Nottingham
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Zip/Postcode
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NG5 1PB
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Country
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United Kingdom
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Tel
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+44 (0)115 840 4792
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Email
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philip.bath@nottingham.ac.uk
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Sponsor
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University of Nottingham (UK)
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Address
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Clinical Sciences Building
City Hospital Campus
Hucknall Road
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City/town
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Nottingham
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Zip/Postcode
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NG5 1PB
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Country
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United Kingdom
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Tel
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+44 (0)115 840 4791
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Fax
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+44 (0)115 840 4790
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Email
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philip.bath@nottingham.ac.uk
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Sponsor website:
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http://www.nottingham.ac.uk/
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Date applied
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26/08/2005
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Last edited
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08/08/2008
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Date ISRCTN assigned
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28/10/2005
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