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Anticoagulant

Blood Thinners for Atrial Fibrillation (ASPIRE-AF Trial)

Phase 4
Recruiting
Led By David Conen, MD, MPH
Research Sponsored by Population Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Noncardiac surgery with at least an overnight hospital admission after surgery in the last 35 days
≥1 episode of clinically important perioperative AF during or after their surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months, until final follow-up
Awards & highlights

ASPIRE-AF Trial Summary

This trial is testing whether a blood thinner can help prevent stroke in patients with a heart rhythm disorder who are undergoing non-cardiac surgery.

Who is the study for?
This trial is for people aged 55-74 with cardiovascular disease, recent major vascular surgery, or a high stroke risk score; or those over 75. Participants must have had noncardiac surgery within the last 35 days and experienced at least one episode of atrial fibrillation afterward. It's not for individuals who need long-term antiplatelet treatment, have contraindications to oral anticoagulants, severe kidney issues, bleeding disorders, are pregnant without contraception use, or have a life expectancy under one year.Check my eligibility
What is being tested?
The study tests if taking a Non-vitamin K oral anticoagulant (NOAC) can prevent strokes and other heart problems in patients who've had temporary atrial fibrillation after non-heart-related surgery compared to no blood thinning treatment.See study design
What are the potential side effects?
Possible side effects of NOACs include bleeding complications such as gastrointestinal bleeds or more rarely brain hemorrhages. They may also cause anemia and potentially affect liver enzymes. Kidney function needs monitoring since NOACs are cleared by the kidneys.

ASPIRE-AF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I had surgery (not heart surgery) and stayed in the hospital overnight within the last 35 days.
Select...
I have had at least one significant episode of AFib during or after surgery.

ASPIRE-AF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months, until final follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months, until final follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Non-hemorrhagic stroke or systemic embolism
Incidence of vascular mortality, and non-fatal non-hemorrhagic stroke, myocardial infarction, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism
Secondary outcome measures
Myocardial Infarction
Incidence of all-cause mortality
Incidence of all-cause stroke
+5 more
Other outcome measures
Hospitalization for all causes
Hospitalization for vascular causes
Incidence of composite of life-threatening, major, and critical organ bleeding
+2 more

ASPIRE-AF Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Non-vitamin K oral anticoagulant (NOAC)Experimental Treatment1 Intervention
Participants randomized to the intervention arm will be prescribed one of the following NOACs for 24 months, unless they are undergoing a procedure with an increased risk of bleeding, have an adverse event or low calculated creatinine clearance, or decide to discontinue their use.
Group II: No anticoagulationActive Control1 Intervention
Participants randomized to the control arm will not be prescribed an oral anticoagulant unless they develop a clear indication for one during follow-up (e.g., recurrent nonoperative AF). They can be newly prescribed or continue taking low dose aspirin or another single antiplatelet agent as per the protocol. This will be decided by the participant's physician.

Find a Location

Who is running the clinical trial?

Hamilton Health Sciences CorporationOTHER
368 Previous Clinical Trials
298,201 Total Patients Enrolled
11 Trials studying Stroke
46,030 Patients Enrolled for Stroke
Population Health Research InstituteLead Sponsor
155 Previous Clinical Trials
677,112 Total Patients Enrolled
16 Trials studying Stroke
114,527 Patients Enrolled for Stroke
David Conen, MD, MPHPrincipal InvestigatorPopulation Health Research Institute
1 Previous Clinical Trials
3,209 Total Patients Enrolled

Media Library

Apixaban (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT03968393 — Phase 4
Stroke Research Study Groups: Non-vitamin K oral anticoagulant (NOAC), No anticoagulation
Stroke Clinical Trial 2023: Apixaban Highlights & Side Effects. Trial Name: NCT03968393 — Phase 4
Apixaban (Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03968393 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risks have been associated with the administration of Non-vitamin K oral anticoagulant (NOAC)?

"We have assessed the safety of Non-vitamin K Oral Anticoagulant (NOAC) as a 3 due to its Phase 4 status and corresponding FDA approval."

Answered by AI

What conditions are NOACs typically prescribed to treat?

"Non-vitamin K oral anticoagulant (NOAC) is a widely employed treatment for vitamin k, and has been successfully used to treat several medical conditions such as cerebrovascular accident, systemic embolism, and ulcerative colitis."

Answered by AI

Has there been prior research conducted on Non-vitamin K oral anticoagulant (NOAC)?

"Presently, there are 109 studies dedicated to Non-vitamin K oral anticoagulant (NOAC) with 41 of them being in the advanced Phase 3. Although most of these trials take place in Lismore, New South Wales, this treatment is tested at a total 2298 sites around the world."

Answered by AI

Are there vacancies available for prospective participants in this experiment?

"Affirmative. The clinical trial's data hosted on clinicaltrials.gov provides evidence that this study is still open to participants, having been first published June 14th 2019 and last edited October 21st 2022. This research requires 2800 patients across a total of 14 medical sites."

Answered by AI

What is the geographical breadth of this experiment?

"Participants for this trial will be recruited from Royal University Hospital in Saskatoon, St. Joseph's Healthcare Hamilton in Ontario, and Centre Hospitalier de l'Université de Montréal in Manitoba as well as 14 other clinical sites throughout the nation."

Answered by AI

How extensive is the current participation in this clinical research project?

"Affirmative. Information found on clinicaltrials.gov reveals that this research trial is currently accepting applicants; it was first posted in June of 2019 and updated as recently as October 2022. 2800 participants are needed to be recruited from 14 different sites."

Answered by AI

Is this the inaugural attempt to conduct such a study?

"Since 2015, Non-vitamin K oral anticoagulant (NOAC) has been under investigation for its therapeutic potential. Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma were the first to conduct a clinical trial in 2015 with 2180 participants and eventually earned Phase 3 drug approval. Nowadays, this medication is being trialled at 109 sites situated across 45 countries around the world."

Answered by AI

Who else is applying?

What site did they apply to?
University of Alberta Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Perioperative AF After Noncardiac Surgery
2019. "Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Perioperative AF After Noncardiac Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03968393.
All > Afib > Pradaxa
~912 spots leftby Sep 2026
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