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

NCT03021928 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-08-08

No results posted yet for this study

Summary

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

Conditions

Interventions

OTHER

Time-To-Treatment Randomization

The time after symptom onset to initiate treatment will be randomized to one of four possible treatment arms: 72 (+/- 24) hours, 132 (+/- 12) hours, 228 (+/- 12) hours, and 324 (+/- 12) hours.

Sponsors & Collaborators

  • Lone Star Stroke Research Consortium

    collaborator UNKNOWN

  • Texas Department of State Health Services

    collaborator OTHER

  • University of Texas at Austin

    lead OTHER

Principal Investigators

  • Steven Warach, MD, PhD · Dell Medical School at The University of Texas at Austin

  • Truman J Milling, MD · Dell Medical School at The University of Texas at Austin

  • Patrick Lawrence, BS · Dell Medical School at The University of Texas at Austin

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-14
Primary Completion
2023-08-03
Completion
2023-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03021928 on ClinicalTrials.gov