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Optimal Delay Time to Initiate Anticoagulation After Ischemic Stroke in Atrial Fibrillation (START Trial)

Phase 3
Waitlist Available
Led By Steven Warach, MD, PhD
Research Sponsored by University of Texas at Austin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Minimum lesion diameter of 1.5cm on qualifying imaging. If lesion not visible on imaging, NIHSS must be greater than 4
Treating physician plans to anticoagulate with a FDA-approved novel oral anticoagulant (NOAC): apixaban, dabigatran, edoxaban, or rivaroxaban, or other FDA-approved NOAC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

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.

Eligible Conditions
  • Stroke

START Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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.
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Your doctor wants to give you a specific type of medication to prevent blood clots.
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You have a new severe problem with your nerves caused by a new type of stroke.
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You have a specific type of irregular heartbeat called non-valvular atrial fibrillation.
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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.
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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.

START Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hemorrhagic Event
Recurrent IschemicEvent
Secondary outcome measures
Modified Rankin Scale

START Trial Design

4Treatment groups
Experimental Treatment
Group I: 72 hours (Day 3-4)Experimental Treatment1 Intervention
Time to delay the initiation of anticoagulation is determined at randomization. The Time-To-Treatment Randomization of 72 (+/-24) hours correlates to starting treatment on Day 3-4.
Group II: 324 hours Day 14.Experimental Treatment1 Intervention
Time to delay the initiation of anticoagulation is determined at randomization. The Time-To-Treatment Randomization of 324 (+/- 12) hours starts Day 14.
Group III: 228 hours (Day 10)Experimental Treatment1 Intervention
Time to delay the initiation of anticoagulation is determined at randomization. The Time-To-Treatment Randomization of 228 (+/- 12) hours correlates to starting treatment on Day 10.
Group IV: 132 hours (Day 6)Experimental Treatment1 Intervention
Time to delay the initiation of anticoagulation is determined at randomization. The Time-To-Treatment Randomization of 132 (+/- 12) hours correlates to starting treatment on Day 6.

Find a Location

Who is running the clinical trial?

Texas Department of State Health ServicesOTHER
3 Previous Clinical Trials
5,128 Total Patients Enrolled
University of Texas at AustinLead Sponsor
347 Previous Clinical Trials
80,112 Total Patients Enrolled
7 Trials studying Stroke
666 Patients Enrolled for Stroke
Lone Star Stroke Research ConsortiumUNKNOWN
1 Previous Clinical Trials
600 Total Patients Enrolled

Media Library

Time-To-Treatment Randomization Clinical Trial Eligibility Overview. Trial Name: NCT03021928 — Phase 3
Stroke Research Study Groups: 72 hours (Day 3-4), 228 hours (Day 10), 324 hours Day 14., 132 hours (Day 6)
Stroke Clinical Trial 2023: Time-To-Treatment Randomization Highlights & Side Effects. Trial Name: NCT03021928 — Phase 3
Time-To-Treatment Randomization 2023 Treatment Timeline for Medical Study. Trial Name: NCT03021928 — Phase 3

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
~26 spots leftby Mar 2025