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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights
No Placebo-Only Group
Pivotal 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
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Hemorrhagic Event
Recurrent IschemicEvent
Secondary study objectives
Modified Rankin Scale
Awards & Highlights
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.
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.
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Who is running the clinical trial?
University of Texas at AustinLead Sponsor
375 Previous Clinical Trials
86,095 Total Patients Enrolled
10 Trials studying Stroke
903 Patients Enrolled for Stroke
Lone Star Stroke Research ConsortiumUNKNOWN
1 Previous Clinical Trials
600 Total Patients Enrolled
Texas Department of State Health ServicesOTHER
3 Previous Clinical Trials
5,128 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- 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)
Awards:
This trial has 2 awards, including:- 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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