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Apixaban + Aspirin for Atrial Fibrillation (ARTESiA Trial)
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.
- Atrial Fibrillation
- Stroke
ARTESiA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 4 trial • 557 Patients • NCT01884337ARTESiA Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Control
- Group 2: Intervention
- 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.
- 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.
Frequently Asked Questions
What is the uppermost cap of participants in this research?
"Recruitment for this clinical trial has concluded as the most recent update was posted on September 26th 2022. However, if you are looking to participate in other studies, there are 1593 trials related to atrial fibrillation and 207 trials connected to Apixaban that remain open for enrolment."
How many medical facilities are currently hosting this research endeavor?
"Currently, this research is being carried out in 47 medical centres. These sites are situated across Ypsilanti, Little Rock and Toronto with other facilities scattered throughout the world. To reduce travel costs when signing up for this study, it's recommended to select the closest clinic you can find."
Could you provide an overview of the research that has been conducted on Apixaban?
"Apixaban has been the focus of numerous clinical trials since 2005, with 621 studies already completed and an additional 207 being actively recruited. Many of these sites are based in Ypsilanti, Arkansas."
Are there open vacancies remaining in this experiment?
"According to the clinicaltrials.gov registry, this particular medical trial is not currently enrolling patients. This study was originally posted on May 1st 2015 with its last update occurring September 26th 2022. Yet, there are a plethora of other trials that have open enrollment at this time - approximately 1800 in total."
Is this particular study the inaugural effort of its type?
"Since 2005, Apixaban has been subject to a number of clinical trials. Abbott sponsored the original study in '05 which included 15480 people and ultimately yielded approval for Phase 4 drug status. Currently, 207 active studies are being conducted across 1452 cities within 62 countries."
Has Apixaban been proven to be a secure medication for individuals?
"Apixaban has already been approved, thus it was awarded a score of 3 to reflect its assessed safety."
What pathologies can Apixaban be applied to?
"Apixaban is a common go-to for deep vein thrombosis treatment, but it also has potential benefits when used to defend against death caused by myocardial infarction and percutaneous coronary intervention (PCI)."
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