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Anticoagulant
Apixaban + Aspirin for Atrial Fibrillation (ARTESiA Trial)
Phase 4
Waitlist Available
Led By Renato Lopes, M.D.
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up event driven, duration of follow-up - mean follow-up time anticipated: 3 years
Awards & highlights
ARTESiA Trial 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
ARTESiA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ event driven, duration of follow-up - mean follow-up time anticipated: 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~event driven, duration of follow-up - mean follow-up time anticipated: 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite of ischemic stroke and systemic embolism
Major Bleed
Secondary outcome measures
All-cause Death
Cardiovascular Death
Composite of stroke, MI, SE and death
+3 moreSide effects data
From 2018 Phase 4 trial • 557 Patients • NCT018843377%
Incision site pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
TOTAL KNEE REPLACEMENT (TKR)
TOTAL HIP REPLACEMENT (THR)
ARTESiA Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Apixaban, 5 mg twice daily (or 2.5 mg twice daily if 2 or more of: age > 80, weight ≤ 60 kg or serum creatinine ≥ 133 mmol/L)
Group II: ControlActive Control1 Intervention
Aspirin 81 mg once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apixaban
FDA approved
Find a Location
Who is running the clinical trial?
PfizerIndustry Sponsor
4,581 Previous Clinical Trials
14,630,216 Total Patients Enrolled
46 Trials studying Atrial Fibrillation
4,351,306 Patients Enrolled for Atrial Fibrillation
MedtronicIndustry Sponsor
610 Previous Clinical Trials
824,727 Total Patients Enrolled
64 Trials studying Atrial Fibrillation
15,259 Patients Enrolled for Atrial Fibrillation
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,348 Previous Clinical Trials
26,451,145 Total Patients Enrolled
20 Trials studying Atrial Fibrillation
645,909 Patients Enrolled for Atrial Fibrillation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Things that make you more likely to have a stroke.You have had a stroke, TIA (mini-stroke), or blood clots, or you are at least 75 years old, or you are 65-74 years old with at least 2 other health risks, or you are 55-64 years old with at least 3 other health risks.High blood pressureCongestive heart failureYou have been diagnosed with atrial fibrillation through specific heart tests, and the abnormal heart rhythm lasts for at least 6 minutes.You have a permanent pacemaker, defibrillator, or insertable cardiac monitor that can detect certain heart conditions.You have a mechanical heart valve, a recent blood clot in your leg or lungs, or need to take a blood thinner for another medical condition.You have diabetes.You are 55 years old or older.Criterion: You cannot participate if you have any of the following:
- Allergy to apixaban or aspirin
- Severe kidney problems
- Recent severe bleeding or high risk of bleeding
- Moderate to severe liver problems
- Need for certain combination therapies
- Need for specific medications
- Received an experimental drug in the past monthYou have had at least one episode of atrial fibrillation lasting 6 minutes or longer, but no episode lasting more than 24 hours before joining the study. Any rapid heart rate episode over 175 beats per minute will be counted as atrial fibrillation. Confirmation by an electrogram is needed for episodes lasting less than 6 hours.You have had a stroke, TIA (mini-stroke), or blood clots in arteries before, or you are at least 55 years old with certain health conditions like high blood pressure, heart problems, diabetes, or artery disease.You have a history of heart or blood vessel disease.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Intervention
Awards:
This trial has 5 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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