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Optimal Delay Time to Initiate Anticoagulation After Ischemic Stroke in Atrial Fibrillation (START Trial)
START Trial Summary
This trial is testing whether it's better to start taking a blood thinner right away or wait a few days after having a stroke. It will also look at whether there are different results for different subgroups of people.
- Stroke
START Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSTART Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.START Trial Design
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Who is running the clinical trial?
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- You are expected to live for less than 90 days.The tumor or abnormality must be at least 1.5cm in size on the scan. If the tumor is not visible on the scan, the NIHSS score must be greater than 4.You have had a bleeding in your brain within the last 6 months.If the stroke damage is too big, or if the doctor can't see all of the damage, and you have a high score on a stroke severity test, you can't join the study.You have a new severe problem with your nerves caused by a new type of stroke.You are expecting to have a major surgery in the next 30 days that would require you to stop taking blood thinners for more than 5 days.You are unconscious or likely to become unconscious.Your doctor wants to give you a specific type of medication to prevent blood clots.If you were taking a blood thinner before your stroke, you can join the study as long as the medicine is no longer working in your body within 48 hours of the stroke.You have swelling and symptoms caused by a stroke.You have a specific type of irregular heartbeat called non-valvular atrial fibrillation.If you had a stroke, the brain scan you had within 48 hours of the stroke needs to show certain things. If you had treatment for your stroke, then the brain scan you had after the treatment needs to show certain things too.
- Group 1: 72 hours (Day 3-4)
- Group 2: 228 hours (Day 10)
- Group 3: 324 hours Day 14.
- Group 4: 132 hours (Day 6)
- 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
Is the FDA's Time-To-Treatment Randomization process endorsed?
"Time-To-Treatment Randomization received a 3, meaning that while it is still in Phase 3 trials, there is already some data supporting its efficacy as well as multiple rounds of safety data."
Is this research still looking for participants?
"The study is still looking for participants, as seen on clinicaltrials.gov. The listing was first put up on 6/14/2017 and last updated on 11/2/2022."
How many people are signing up to participate in this research study?
"Yes, this is an ongoing clinical trial that was posted on 6/14/2017. The latest update was on 11/2/2022. They are looking for 200 participants across 15 sites."
In how many different settings is this trial taking place?
"Out of the 15 different sites that are participating in this trial, patients can choose the one closest to them to minimize travel time and inconvenience. Locations include Austin, El Paso, Round Rock, and 12 others."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
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