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NCT03950076 · ClinicalTrials.gov registry record · Phase 4

EdoxabaN foR IntraCranial Hemorrhage Survivors With Atrial Fibrillation (ENRICH-AF)

A Phase 4 study of Atrial Fibrillation and Intracranial Hemorrhages, sponsored by Population Health Research Institute.

Active
Registry status
Phase 4
Development phase
948
Enrollment target
20
Study locations

NCT03950076 is a Phase 4 study of Atrial Fibrillation and Intracranial Hemorrhages that is active but no longer recruiting, run by Population Health Research Institute. The registered enrollment target is 948 participants, below the 2,992-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (68% lower). The trial reports 20 study locations across 7 states.

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The verdict

NCT03950076, a Phase 4 study of Atrial Fibrillation and Intracranial Hemorrhages, is active but no longer recruiting, sponsored by Population Health Research Institute.

ACTIVE NOT RECRUITING
Registry status
Phase 4
Development phase
948 participants
Enrollment target
20
Study locations

Study Summary

To assess whether edoxaban (60/30 mg daily) compared to non-antithrombotic medical therapy (either no antithrombotic therapy or antiplatelet monotherapy) reduces the risk of stroke (composite of ischemic, hemorrhagic and unspecified stroke) or systemic embolism in high-risk atrial fibrillation (CHA2DS2-VASc ≥2) patients with previous intracranial hemorrhage.

Interventions

  • DRUG Edoxaban
  • OTHER Non-anticoagulant medical therapy

Study Locations (20)

Other

  • Stat Research S.A. - Buenos Aires
  • Hospital Italiano de Buenos Aires - Buenos Aires
  • Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI) - Buenos Aires
  • Hospital Policial Churruca-Visca - Buenos Aires
  • Centro Instituto Neurologico Salta - Salta
  • Medical University of Innsbruck - Innsbruck
  • Institut für Akutneurologie und Stroke Unit (IANS), Landeskrankenhaus Feldkirch - Rankweil
  • Medical University of Vienna, Dept. of Neurology - Vienna
  • Salzkammergutklinikum Vöcklabruck - Vöcklabruck
  • Erasme Hospital - Brussels

Texas

  • The University of Texas at Austin, Dell Medical School - Austin
  • Texas Tech University Health Sciences Center at El Paso - El Paso
  • Baylor St. Luke's Medical Center - Houston

Illinois

  • Alexian Brothers Medical Center - Elk Grove Village
  • Presence Care Transformation Corporation - Lisle

Pennsylvania

  • The Hospital of the University of Pennsylvania - Philadelphia
  • Allegheny General Hospital - Pittsburgh

Louisiana

  • Tulane University Medical Center - New Orleans

New York

  • New York Presbyterian - Queens - Queens

Washington

  • MultiCare Institute for Research & Innovation - Tacoma

Trial Details

FieldValue
Enrollment Target 948 participants
Start Date 2019-09-20
Est. Completion 2026-05-13
Phase Phase 4

What the Registry Record Tells You About NCT03950076

The ClinicalTrials.gov registry entry for NCT03950076 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 948 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,992-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (68% lower). The listed sponsor is Population Health Research Institute, which has 21 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Atrial Fibrillation appearing as the primary indexed condition, and to 2 interventions - of which Edoxaban is the first listed.

NCT03950076 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Other, Texas, Illinois.

Frequently Asked Questions

What is clinical trial NCT03950076 about?

NCT03950076 is a clinical study titled "EdoxabaN foR IntraCranial Hemorrhage Survivors With Atrial Fibrillation (ENRICH-AF)". To assess whether edoxaban (60/30 mg daily) compared to non-antithrombotic medical therapy (either no antithrombotic therapy or antiplatelet monotherapy) reduces the risk of stroke (composite of ischemic, hemorrhagic and unspecified stroke) or systemic embolism in high-risk atrial fibrillation (CHA2...

What is the current status of trial NCT03950076?

This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 948 participants. The study started on 2019-09-20. Estimated completion is 2026-05-13.

What conditions does trial NCT03950076 study?

This clinical trial studies the following conditions: Atrial Fibrillation, Intracranial Hemorrhages.

What interventions are being tested in trial NCT03950076?

The interventions under investigation include: Edoxaban (DRUG), Non-anticoagulant medical therapy (OTHER).

Who is sponsoring clinical trial NCT03950076?

This trial is sponsored by Population Health Research Institute, which has 21 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03950076 being conducted?

This trial has 20 study locations across Illinois, Louisiana, New York, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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