Testing Non-vitamin K for stroke
Official title: Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Atrial Fibrillation Occurring Transiently With Stress
Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Atrial Fibrillation Occurring Transiently With Stress - The ASPIRE-AF Trial
- Phase 4
- 2 groups
- Sites in Calgary, Edmonton and 20 more cities
- Recruiting
Interventions
- Medication
Non-vitamin K oral anticoagulant (NOAC)
Participants randomized to the intervention arm will be prescribed one of the following NOACs for the duration of follow-up: edoxaban 60 mg daily (dose reduction to 30 mg, if applicable), apixaban 5 mg twice daily (dose reduction to 2.5 mg, if applicable), dabigatran 110 mg twice daily, or rivaroxaban 20 mg daily (dose reduction to 15 mg, if applicable). The choice of NOAC will be left up to the participant's prescribing physician.
Canadian Sites (24)
20 of 24 recruiting
- Recruiting
Foothills Hospital
Calgary, Alberta
- Recruiting
University of Alberta Hospital
Edmonton, Alberta
- Recruiting
Medicine Hat Regional Hospital
Medicine Hat, Alberta
- Recruiting
Fraser Health Authority
Surrey, British Columbia
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia
- Recruiting
Health Sciences Centre Winnipeg
Winnipeg, Manitoba
- Recruiting
Halifax Infirmary
Halifax, Nova Scotia
- Recruiting
Cape Breton University
Sydney, Nova Scotia
- Recruiting
Hamilton General Hospital
Hamilton, Ontario
- Recruiting
St. Joseph's Healthcare Hamilton
Hamilton, Ontario
- Recruiting
Juravinski Hospital
Hamilton, Ontario
- Recruiting
Kingston General Hospital
Kingston, Ontario
- Recruiting
London Health Sciences Centre - University Hospital
London, Ontario
- Recruiting
The Ottawa Hospital General Campus
Ottawa, Ontario
- Recruiting
Niagara Health System - St. Catharine's Site
St. Catharines, Ontario
- Recruiting
Cortelluci Vaughan Hospital
Vaughan, Ontario
- Recruiting
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec
- Recruiting
Hôpital Fleurimont du Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec
- Recruiting
Regina General Hospital
Regina, Saskatchewan
- Recruiting
Royal University Hospital
Saskatoon, Saskatchewan
- Not yet recruiting
East Kootenay Regional Hospital
Cranbrook, British Columbia
- Not yet recruiting
Dr.-Georges-L.-Dumont University Hospital Centre
Moncton, New Brunswick
- Not yet recruiting
Cambridge Cardiac Care Centre
Cambridge, Ontario
- Not yet recruiting
CHU de Quebec Universite Laval
Québec, Quebec
Eligibility Criteria
See who this study is looking for25 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +age ≥75 years.;
- +have ≥1 episode of clinically important AFOTS during any of the following conditions:
- +acute medical illness requiring hospital admission in the past 35 days and resulting in a large enough physiological insult to be able to cause AFOTS, as judged by the local investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →;
- +sinus rhythm at the time of randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →;
- +any of the following high-risk criteria:
- +provide written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- +noncardiac surgery in the past 35 days, with at least an overnight hospital admission aftersurgery;
- +noncardiac day surgery resulting in a large enough physiological insult to be able to cause AFOTS, as judged by the local investigator; or
- +age 55-64 years, and having either known cardiovascular disease, recent major vascular surgery, a CHA2DS2VASc score ≥3, or an elevated postoperative troponin level;
- +age 65-74 years, and having either known cardiovascular disease, recent major vascular surgery, a CHA2DS2VASc score ≥2, or an elevated postoperative troponin level; OR
Exclusion
- −any cardiac diagnosis as the primary reason for hospital admission;
- −need for long-term systemic anticoagulation;
- −ongoing need for long-term dual antiplatelet treatment;
- −contraindication to oral anticoagulation;
- −severe renal insufficiency (CrCl \<20 ml/min);
- −severe liver cirrhosis (i.e., Child-Pugh Class C)
- −acute stroke in the past 14 days;
- −history of nontraumatic intracranial, intraocular, or spinal bleeding;
- −hemorrhagic disorder or bleeding diathesis;
- −expected to be non-compliant with follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → and/or study medications;
- −known life expectancy less than 1 year due to concomitant disease;
- −previously enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → in the trial
- −women who are pregnant, breastfeeding, or of childbearing potential who are not taking effective contraception; OR
- −history of documented chronic AF prior to noncardiac surgery;
- −underwent cardiac surgery in the past 35 days;
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to prevent a condition from developing.
Phase 4Phase 4A study of a treatment that is already approved and in use.Read more → — a study of a treatment already approved for use, following it in everyday practice.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Non-vitamin K oral anticoagulant (NOAC).
Registry label: A: Non-vitamin K oral anticoagulant (NOAC)
Group B receives no study treatment and is followed for comparison.
Registry label: B: No anticoagulation
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment at all, and is followed for comparison.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 55 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 2,270 people.
The study is currently expected to finish around December 2028.
The main measurement is taken over: For the duration of follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →, until final follow-up (occurs when the last global participant has been followed for 24 months).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Incidence of Non-hemorrhagic stroke or systemic embolism — measured over For the duration of follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →, until final follow-up (occurs when the last global participant has been followed for 24 months).
Incidence of vascular mortality, and non-fatal non-hemorrhagic stroke, myocardial infarction, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism — measured over For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months).
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT03968393 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Non-vitamin K oral anticoagulant (NOAC)Drug
Participants randomized to the intervention arm will be prescribed one of the following NOACs for the duration of follow-up: edoxaban 60 mg daily (dose reduction to 30 mg, if applicable), apixaban 5 mg twice daily (dose reduction to 2.5 mg, if applicable), dabigatran 110 mg twice daily, or rivaroxaban 20 mg daily (dose reduction to 15 mg, if applicable). The choice of NOAC will be left up to the participant's prescribing physician.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 55 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment and is followed for comparison.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 55 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: For the duration of follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →, until final follow-up (occurs when the last global participant has been followed for 24 months).
The study as a whole is currently expected to finish around 2028-12.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 2,270 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 22 locations, including: Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Medicine Hat, Alberta, Canada; Cranbrook, British Columbia, Canada; Surrey, British Columbia, Canada; Vancouver, British Columbia, Canada, and 16 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Multinational, investigator-initiated study of oral anticoagulation versus no anticoagulation for the prevention of stroke and other adverse cardiovascular events in patients with transient atrial fibrillation occurring transiently with stress and additional stroke risk factors.
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.