Contact information
Type
Scientific
Primary contact
Prof Philip Bath
ORCID ID
Contact details
Division of Stroke Medicine
Clinical Sciences Building
City Hospital Campus
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
+44 (0)115 840 4792
philip.bath@nottingham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Triple 2
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Aspirin, clopidogrel, dipyridamole
Primary outcome measures
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 trial start date
26/10/2001
Overall trial end date
28/02/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
51
Participant 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
Recruitment start date
26/10/2001
Recruitment end date
28/02/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Division of Stroke Medicine
Nottingham
NG5 1PB
United Kingdom
Sponsor information
Organisation
University of Nottingham (UK)
Sponsor details
Clinical Sciences Building
City Hospital Campus
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
+44 (0)115 840 4791
philip.bath@nottingham.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Nottingham (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in http://www.ncbi.nlm.nih.gov/pubmed/18682741
Publication citations
-
Results
Sprigg N, Gray LJ, England T, Willmot MR, Zhao L, Sare GM, Bath PM, A randomised controlled trial of triple antiplatelet therapy (aspirin, clopidogrel and dipyridamole) in the secondary prevention of stroke: safety, tolerability and feasibility., PLoS ONE, 2008, 3, 8, e2852, doi: 10.1371/journal.pone.0002852.