Printed from Voxsanity (voxsanity.com.au) — NCT00412984 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.
Trial results
AI generated results summary.
Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source.
How we use AI
According to the results reported on ClinicalTrials.gov, this trial (known as ARISTOTLE) enrolled 18,201 people with a heart rhythm problem called atrial fibrillation who were at risk of stroke. Participants were randomly assigned to take either apixaban (9,120 people) or warfarin (9,081 people). The trial was measuring how often people experienced a stroke or a blockage of blood flow to a part of the body (called systemic embolism), as well as serious bleeding episodes and deaths from any cause.
The reported data shows that for the primary outcome — stroke or systemic embolism — 212 participants in the apixaban group and 265 in the warfarin group had at least one such event during the study period. Broken down further, the reported figures include 159 apixaban participants and 173 warfarin participants with an ischaemic or unspecified stroke, 38 versus 76 with a haemorrhagic (bleeding into the brain) stroke, and 15 versus 16 with systemic embolism. Expressed as a rate per 100 person-years (a way of accounting for different lengths of follow-up), this was 1.27 for apixaban and 1.60 for warfarin. For serious bleeding, 327 people in the apixaban group and 462 in the warfarin group experienced a major bleed, corresponding to rates of 2.13 and 3.09 per 100 person-years respectively. For deaths from any cause, 603 people in the apixaban group and 669 in the warfarin group died during the intended treatment period, at rates of 3.52 and 3.94 per 100 person-years.
These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Stroke Trial, Completed
NCT00412984
CompletedPhase 3🇦🇺 Australian site
Who may be able to join
AI generated eligibility summary.
Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source.
How we use AI
Who might be able to join this trial:
You are a man or woman aged 18 or older who has been diagnosed with atrial fibrillation (an irregular heartbeat)
You are aged 75 or older
You have previously had a stroke
You have previously had a transient ischemic attack (TIA, sometimes called a "mini-stroke") or a blood clot that travelled to another part of the body
You have heart failure with symptoms, or your heart has been found to pump weakly (less than 40% of its normal capacity)
You have diabetes or high blood pressure that requires medication to control it
Who may not be able to join:
No specific exclusion criteria were listed in the information provided (confirm with trial site)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 14 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.
Contact this trial
Principal Investigator: Bristol-Myers Squibb, Bristol-Myers Squibb
Australian sites
Local Institution, Coffs Harbour, New South Wales
Local Institution, Concord, New South Wales
Local Institution, Gosford, New South Wales
Local Institution, Kogarah, New South Wales
Local Institution, Miranda, New South Wales
Local Institution, Auchenflower, Queensland
Local Institution, Brisbane, Queensland
Local Institution, Caboolture, Queensland
Local Institution, Herston, Queensland
Local Institution, Kippa-Ring, Queensland
Local Institution, Nambour, Queensland
Local Institution, Sherwood, Queensland
Local Institution, Adelaide, South Australia
Local Institution, Ashford, South Australia
Local Institution, Bedford Park, South Australia
Local Institution, Woodville, South Australia
Local Institution, Box Hill, Victoria
Local Institution, Dandenong, Victoria
Local Institution, Geelong, Victoria
Local Institution, Fremantle, Western Australia
Local Institution, Joondalup, Western Australia
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Voxsanity
Clinical trials and treatments, explained plainly · voxsanity.com.au
Date:
To: My Doctor
Re: Clinical trial enquiry
I found the following past clinical trial relevant to my condition, and wanted to raise it with you. It is no longer recruiting, but I wanted to ask whether similar active trials exist, or whether its results are relevant to my care:
Trial: NCT00412984
Sponsor: Bristol-Myers Squibb
Phase: Phase 3
Status: Completed
Condition: Stroke
More information: https://clinicaltrials.gov/study/NCT00412984
Eligibility summary (AI generated)
Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.
Who might be able to join this trial:
You are a man or woman aged 18 or older who has been diagnosed with atrial fibrillation (an irregular heartbeat)
You are aged 75 or older
You have previously had a stroke
You have previously had a transient ischemic attack (TIA, sometimes called a "mini-stroke") or a blood clot that travelled to another part of the body
You have heart failure with symptoms, or your heart has been found to pump weakly (less than 40% of its normal capacity)
You have diabetes or high blood pressure that requires medication to control it
Who may not be able to join:
No specific exclusion criteria were listed in the information provided (confirm with trial site)
Important: Always verify eligibility with the trial site directly before applying.
Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.
This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 14 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.
🇦🇷 Argentina
🇦🇺 Australia
🇦🇹 Austria
🇧🇪 Belgium
🇧🇷 Brazil
🇨🇦 Canada
🇨🇱 Chile
🇨🇳 China
🇨🇴 Colombia
🇨🇿 Czechia
🇩🇰 Denmark
🇫🇮 Finland
🇫🇷 France
🇩🇪 Germany
Hong Kong
🇭🇺 Hungary
🇮🇳 India
🇮🇱 Israel
🇮🇹 Italy
🇯🇵 Japan
🇲🇾 Malaysia
🇲🇽 Mexico
🇳🇱 Netherlands
🇳🇴 Norway
🇵🇪 Peru
🇵🇭 Philippines
🇵🇱 Poland
Puerto Rico
🇷🇴 Romania
🇷🇺 Russia
🇸🇬 Singapore
🇿🇦 South Africa
🇰🇷 South Korea
🇪🇸 Spain
🇸🇪 Sweden
🇨🇭 Switzerland
🇹🇼 Taiwan
Turkey (Türkiye)
🇺🇦 Ukraine
🇬🇧 United Kingdom
🇺🇸 United States
21 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Number of Participants With First Event of Ischemic/Unspecified Stroke, Hemorrhagic Stroke, or Systemic Embolism (SE) During the Intended Treatment Period; Rate of Adjudicated Stroke or Systemic Embolism (SE) During the Intended Treatment Period
Can't join this trial?
Expanded access pathways
If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.
Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.