Apixaban for Atrial Fibrillation

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Atrial Fibrillation+3 More
Apixaban - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare apixaban with aspirin to see which reduces the risk of stroke better in patients with atrial fibrillation and other stroke risk factors.

Eligible Conditions
  • Atrial Fibrillation
  • Stroke

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: event driven, duration of follow-up - mean follow-up time anticipated: 3 years

Duration of Follow-up
Ischemic Stroke
Duration of follow-up
All-cause Death
Cardiovascular Death
Composite of stroke, MI, SE and death
Composite of stroke, MI, SE, death and major bleeding
Myocardial Infarction
duration of follow-up
Major Bleed
Year 3
Composite of ischemic stroke and systemic embolism

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

TOTAL KNEE REPLACEMENT (TKR)
7%Incision site pain
This histogram enumerates side effects from a completed 2018 Phase 4 trial (NCT01884337) in the TOTAL KNEE REPLACEMENT (TKR) ARM group. Side effects include: Incision site pain with 7%.

Trial Design

2 Treatment Groups

Control
1 of 2
Intervention
1 of 2

Active Control

Experimental Treatment

4012 Total Participants · 2 Treatment Groups

Primary Treatment: Apixaban · No Placebo Group · Phase 4

Intervention
Drug
Experimental Group · 1 Intervention: Apixaban · Intervention Types: Drug
Control
Drug
ActiveComparator Group · 1 Intervention: aspirin · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apixaban
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: event driven, duration of follow-up - mean follow-up time anticipated: 3 years

Who is running the clinical trial?

Population Health Research InstituteLead Sponsor
142 Previous Clinical Trials
657,827 Total Patients Enrolled
26 Trials studying Atrial Fibrillation
41,859 Patients Enrolled for Atrial Fibrillation
Bristol-Myers SquibbIndustry Sponsor
2,483 Previous Clinical Trials
3,915,864 Total Patients Enrolled
67 Trials studying Atrial Fibrillation
1,591,005 Patients Enrolled for Atrial Fibrillation
MedtronicIndustry Sponsor
571 Previous Clinical Trials
728,636 Total Patients Enrolled
62 Trials studying Atrial Fibrillation
15,119 Patients Enrolled for Atrial Fibrillation
PfizerIndustry Sponsor
4,264 Previous Clinical Trials
7,104,450 Total Patients Enrolled
43 Trials studying Atrial Fibrillation
583,029 Patients Enrolled for Atrial Fibrillation
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,223 Previous Clinical Trials
24,399,721 Total Patients Enrolled
20 Trials studying Atrial Fibrillation
647,139 Patients Enrolled for Atrial Fibrillation
Marco Alings, M.D.Principal InvestigatorWorking Group Cardiovascular Research Netherlands
1 Previous Clinical Trials
256 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
256 Patients Enrolled for Atrial Fibrillation
Renato Lopes, M.D.Principal InvestigatorDuke Clinical Research Institute
Jeff Healey, M.D.3.02 ReviewsPrincipal Investigator - Population Health Research Institute
Population Health Research Institute
2 Previous Clinical Trials
385 Total Patients Enrolled
2 Trials studying Atrial Fibrillation
385 Patients Enrolled for Atrial Fibrillation
5Patient Review
I went to see Dr. Healey for a swollen, red eyelid. He did a thorough exam and gave me eye drops that took care of the problem quickly. He had me come in for a follow up and told me how to handle any future flare ups. Thank you, Dr. Healey!
Stuart Connolly, M.D.Study ChairPopulation Health Research Institute
2 Previous Clinical Trials
385 Total Patients Enrolled
2 Trials studying Atrial Fibrillation
385 Patients Enrolled for Atrial Fibrillation

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have had a stroke, TIA or systemic arterial embolism, or are aged 75 or older
You have diabetes.\n
You are female.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 4th, 2021

Last Reviewed: November 5th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
California100.0%
How old are they?
65+100.0%
What site did they apply to?
Cardiovascular Associates of Marin and San Francisco Medical100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%