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

Recruiting in Palo Alto (17 mi)

+14 other locations

Overseen bySteven Warach, MD, PhD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: University of Texas at Austin

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?Title: Optimal Delay Time to Initiate Anticoagulation after Ischemic Stroke in Atrial Fibrillation (START): a pragmatic, adaptive randomized clinical trial. Primary Objective: • To determine the optimal time to initiate anticoagulation with a Non-Vitamin K Oral Anticoagulant (NOAC) after ischemic stroke in patients with non-valvular atrial fibrillation. Secondary Objectives: * To compare the rates of primary adverse outcomes in a per protocol analysis * To compare 30 day clinical outcomes by the modified Rankin scale among the time-to-treatment groups * To compare 90 day clinical outcomes by the modified Rankin scale among the time-to-treatment groups * To explore the optimal timing in subgroups of age, sex, outcome category, and NOAC choice

Eligibility Criteria

Inclusion Criteria

Not currently anticoagulated and/or will not be anticoagulated prior to starting their NOAC at the randomized time of initiation (except for DVT prophylaxis)

Ability to randomize within 60 hours of symptom onset

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.

+5 more

Exclusion Criteria

Follow-up in person or by telephone for 90 days is not feasible

You are expected to live for less than 90 days.

You have had a bleeding in your brain within the last 6 months.

+4 more

Participant Groups

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.