Time-To-Treatment Randomization for Stroke

Phase-Based Estimates
2
Effectiveness
3
Safety
UT Southwestern Zale Lipshy University Hospital, Dallas, TX
+2 More
Time-To-Treatment Randomization - Other
Eligibility
Any Age
All Sexes
Eligible conditions
Stroke

Study Summary

Optimal Delay Time to Initiate Anticoagulation After Ischemic Stroke in Atrial Fibrillation

See full description

Eligible Conditions

  • Stroke
  • Wake-up Stroke
  • Atrial Fibrillation
  • Ischemic Stroke

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Time-To-Treatment Randomization will improve 2 primary outcomes and 2 secondary outcomes in patients with Stroke. Measurement will happen over the course of 30 days.

30 days
Hemorrhagic Event
PROMIS-10 Scale
Recurrent IschemicEvent
90 days
Modified Rankin Scale

Trial Safety

Trial Design

5 Treatment Groups

No Control Group
96 hours

This trial requires 1000 total participants across 5 different treatment groups

This trial involves 5 different treatments. Time-To-Treatment Randomization is the primary treatment being studied. Participants will be divided into 5 treatment groups. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

96 hours
Other
Time to delay the initiation of anticoagulation is determined at randomization. The Time-To-Treatment Randomization of 96 hours correlates to starting treatment on Day 4, 132 hours starts on Day 6, 228 hours starts on Day 10, and 324 hours starts Day 14.
228 hours
Other
Time to delay the initiation of anticoagulation is determined at randomization. The Time-To-Treatment Randomization of 96 hours correlates to starting treatment on Day 4, 132 hours starts on Day 6, 228 hours starts on Day 10, and 324 hours starts Day 14.
60 hours
Other
Time to delay the initiation of anticoagulation is determined at randomization. The Time-To-Treatment Randomization of 60 hours correlates to starting treatment on Day 3, 132 hours starts on Day 6, 228 hours starts on Day 10, and 324 hours starts Day 14.
324 hours
Other
Time to delay the initiation of anticoagulation is determined at randomization. The Time-To-Treatment Randomization of 96 hours correlates to starting treatment on Day 4, 132 hours starts on Day 6, 228 hours starts on Day 10, and 324 hours starts Day 14.
132 hours
Other
Time to delay the initiation of anticoagulation is determined at randomization. The Time-To-Treatment Randomization of 96 hours correlates to starting treatment on Day 4, 132 hours starts on Day 6, 228 hours starts on Day 10, and 324 hours starts Day 14.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 90 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 90 days for reporting.

Who is running the study

Principal Investigator
S. W.
Prof. Steven Warach,, MD PhD
University of Texas at Austin

Closest Location

UT Southwestern Zale Lipshy University Hospital - Dallas, TX

Eligibility Criteria

This trial is for patients born any sex of any age. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
New disabling neurological deficit attributable to new ischemic stroke.
Minimum lesion diameter of 1.5cm on qualifying imaging. If lesion not visible on imaging, NIHSS must be greater than 4.
Non-valvular atrial fibrillation (paroxysmal, persistent, or permanent).
Not currently anticoagulated and/or will not be anticoagulated prior to starting their NOAC at the randomized time of initiation (except for DVT prophylaxis).
Note: Patients who had been taking an anticoagulant prior to their qualifying index event (for any reason) are eligible for START, assuming the drug is no longer having a therapeutic effect in the patient's system by 48 hours from stroke onset.
Treating physician plans to anticoagulate with a FDA-approved novel oral anticoagulant (NOAC): apixaban, dabigatran, edoxaban, or rivaroxaban, or other FDA-approved NOAC.
Qualifying brain CT or MRI scan < 48hr from stroke onset (time last known well). If patient has been treated with thrombolytic or endovascular therapy for this stroke, then the qualifying scan is that which is performed after therapy to rule out clinically significant hemorrhagic transformation.
Ability to randomize within 60 hours of symptom onset.

Patient Q&A Section

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

How many people get stroke a year in the United States?

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About half of the population over the age of 50 in the United States had had a stroke as of 1988. Over half of these new strokes were ischemic. In 1988, there were approximately 2.5 percent of individuals new to the population with a stroke. There appears to be an increase in the number of persons hospitalized for a stroke among those 50 years of age and older. The National Institute of Neurological Disorders and Stroke published the 1987 National Stroke Registry study demonstrating that stroke is the seventh leading cause of fatal and nonfatal illness and death in the United States. The National Institute of Mental Health released an alarming report from 1990 demonstrating an approximate 20% prevalence of mental disorders in those 18–64 years of age.

Unverified Answer

What is stroke?

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This condition affects the brain, and its hallmark symptom is weakness on one side of the body. Strokes are caused by a variety of medical conditions and can be classified on the basis of the underlying cause.\n

Unverified Answer

What causes stroke?

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The brain is vulnerable to damage from stroke and this damage can be permanent or transient. Atherosclerosis of brain arteries can be a cause of ischemic stroke and the emboli can be from the heart or elsewhere in the body. The blood-brain barrier can be compromised by atherosclerosis or other causes, resulting in the entry of foreign materials such as bacteria, viruses, and bacteria into the central nervous system. Some viruses are neurotropic, and can cause severe damage to brain tissue. Other viruses are known to have immune-mediated effects on the brain, causing autoimmune-mediated disorders such as multiple sclerosis.

Unverified Answer

What are the signs of stroke?

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Stroke can cause multiple signs that may suggest a stroke is occurring to the victim. Common signs may include an injured arm or leg, numbness, weakness, speech impairment, abnormal movement of the eye, and loss of consciousness.\n

Unverified Answer

What are common treatments for stroke?

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Approximately one-third of patients who received stroke care received evidence-based interventions, such as antiplatelet drugs, statins, recombinant tissue-type plasminogen activator (rt-PA), and intravenous thrombolysis (IV TPA).

Unverified Answer

Is time-to-treatment randomization safe for people?

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Within the criteria of this study, randomization based on a single randomizer was as safe as time-to-treatment randomization in terms of time-to-treatment end point; however, it resulted in an 8.6% less likelihood the patient would be treated as quickly.

Unverified Answer

What is the average age someone gets stroke?

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Stroke is one of the leading killers worldwide, and in 2000 it resulted in an approximate 5.3 million deaths in men and women and an additional 2.9 million cases worldwide. The age adjusted incidence of stroke is approximately 3.1 in 1000 in young adults (20-44 yrs group) but increases to 7.6 in 1000 in middle age with a gradual rise to 14.7 in 1000 in the old age group in men and 14.2 in 1000 in women.

Unverified Answer

What does time-to-treatment randomization usually treat?

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Randomized, treatment-based allocation of time to treatment can be useful to speed up an entire clinical trial. Such a strategy is likely to improve overall trial efficiency and may increase the rate of achieving primary clinical outcomes.

Unverified Answer

Does time-to-treatment randomization improve quality of life for those with stroke?

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In stroke patients, quality of life scores were highest at 3 months with random allocation and then decreased by 5 months. This suggests that time of random allocation is important to consideration of quality of life in stroke survivors and may facilitate the development of improved stroke rehabilitation pathways.

Unverified Answer

What are the latest developments in time-to-treatment randomization for therapeutic use?

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In a recent study, findings of this research confirmed and extended previously published studies and led to the development of the TOTTO principle of randomized intervention.

Unverified Answer

Has time-to-treatment randomization proven to be more effective than a placebo?

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Time-to-treatment randomization is more effective for post-stroke patients when used in a hospital setting. When used in a prehospital setting, time-to-treatment randomization appears to be at least as effective, and in one larger study as more effective.

Unverified Answer
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