Combined aspirin, clopidogrel and dipyridamole versus aspirin alone in stroke secondary prevention: a safety, tolerability and feasibility study

ISRCTN	ISRCTN83673558
DOI	https://doi.org/10.1186/ISRCTN83673558
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Philip Bath
Scientific

Division of Stroke Medicine
Clinical Sciences Building
City Hospital Campus
Hucknall Road
Nottingham
NG5 1PB
United Kingdom

Phone	+44 (0)115 840 4792
Email	philip.bath@nottingham.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Prevention
Scientific title
Study acronym	Triple 2
Study objectives	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.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Ischaemic stroke
Intervention	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.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Aspirin, clopidogrel, dipyridamole
Primary outcome measure	Number of subjects completing randomised treatment to final follow up.
Secondary outcome measures	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
Overall study start date	26/10/2001
Completion date	28/02/2008

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	51
Key inclusion criteria	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
Key exclusion criteria	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
Date of first enrolment	26/10/2001
Date of final enrolment	28/02/2008

Division of Stroke Medicine

Nottingham
NG5 1PB
United Kingdom

University of Nottingham (UK)
University/education

Clinical Sciences Building
City Hospital Campus
Hucknall Road
Nottingham
NG5 1PB
England
United Kingdom

University/education

University of Nottingham (UK)
Private sector organisation / Universities (academic only)

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	06/08/2008		Yes	No