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NCT02100228 · ClinicalTrials.gov registry record · Phase 4

Study Of The Blood Thinner, Apixaban, For Patients Who Have An Abnormal Heart Rhythm (Atrial Fibrillation) And Expected To Have Treatment To Put Them Back Into A Normal Heart Rhythm (Cardioversion)

A Phase 4 study of Atrial Fibrillation, sponsored by Pfizer.

Completed
Registry status
Phase 4
Development phase
1,500
Enrollment target
20
Study locations

NCT02100228 is a Phase 4 study of Atrial Fibrillation that has completed, run by Pfizer. The registered enrollment target is 1,500 participants, below the 2,989-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (50% lower). The trial reports 20 study locations across 8 states.

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The verdict

NCT02100228, a Phase 4 study of Atrial Fibrillation, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 4
Development phase
1,500 participants
Enrollment target
20
Study locations

Study Summary

Some people can develop an abnormal heart beat known as "Atrial fibrillation" or "AF" that puts them at risk of developing clots in the heart. Those clots can travel in the blood circulation to the brain and cause a brain attack ("a stroke"). To prevent those clots forming, blood thinners (anti-coagulants) are used. Apixaban is a blood thinner that works by stopping one of the blood substances required for clotting ("Factor Xa"). It is approved and used to prevent clots forming in people with "AF". Other established blood thinners work by stopping clotting substances being made, known as "Vitamin K antagonists" or "VKAs". An example of this type is Warfarin (Coumadin). The good effects of all blood thinners are preventing clots, and they may also have bad effects of increasing the chance of bleeding. People with "AF", abnormal heart beat, may benefit from changing it back to a normal regular rhythm, known medically as "cardioversion". When this is done, people are currently most commonly treated with a "VKA" blood thinner (e.g. warfarin). The purpose of this study is to assess the good and bad effects ("efficacy" and "safety") of apixaban compared with warfarin in people with "AF" in whom an early cardioversion is planned.

Conditions Studied

Atrial Fibrillation

Interventions

  • DRUG Apixaban
  • DRUG Parenteral heparin and/or oral Vitamin K antagonist

Study Locations (20)

Kentucky

  • UK Good Samaritan Medical Office Building - Lexington
  • Good Samaritan Hospital - Lexington
  • University of Kentucky Medical Center Gill Heart Institute - Lexington
  • University of Kentucky Gill Heart Institute - Lexington
  • University of Kentucky HealthCare/Albert. B, Chandler Hospital - Lexington
  • Aim Clinic - Louisville
  • Cardiology Outpatient Clinic - Louisville

Illinois

  • The University of Chicago Medical Center Investigational Drug Service Pharmacy (office/storage) - Chicago
  • The University of Chicago Medical Center Investigational Drug Service Pharmacy - Chicago
  • University of Chicago Medical Center - Chicago
  • Chicago Medical Research, LLC - Hazel Crest

Alabama

  • Brookwood Medical Center - Birmingham
  • Cardiovascular Associates of the Southeast, LLC - Birmingham

Florida

  • Certified Physician Investigator Research Group LLC - Altamonte Springs
  • Orlando Heart Specialists - Altamonte Springs

Indiana

  • Franciscan Physician Network-Indiana Heart Physicians - Indianapolis
  • Franciscan St. Francis Health - Indianapolis

Arizona

  • Integrated Medical Services, Inc./IMS Cardiology - Avondale

California

  • Chula Vista Cardiac Center - Chula Vista

Connecticut

  • Hartford Hospital - Hartford

Trial Details

FieldValue
Enrollment Target 1,500 participants
Start Date 2014-07-14
Est. Completion 2017-02-08
Phase Phase 4

Sponsor

Pfizer

1,845 total trials

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What the Registry Record Tells You About NCT02100228

The ClinicalTrials.gov registry entry for NCT02100228 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 1,500 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,989-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (50% lower). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Atrial Fibrillation appearing as the primary indexed condition, and to 2 interventions - of which Apixaban is the first listed.

NCT02100228 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Kentucky, Illinois, Alabama.

Frequently Asked Questions

What is clinical trial NCT02100228 about?

NCT02100228 is a clinical study titled "Study Of The Blood Thinner, Apixaban, For Patients Who Have An Abnormal Heart Rhythm (Atrial Fibrillation) And Expected To Have Treatment To Put Them Back Into A Normal Heart Rhythm (Cardioversion)". Some people can develop an abnormal heart beat known as "Atrial fibrillation" or "AF" that puts them at risk of developing clots in the heart. Those clots can travel in the blood circulation to the brain and cause a brain attack ("a stroke"). To prevent those clots forming, blood thinners (anti-coag...

What is the current status of trial NCT02100228?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,500 participants. The study started on 2014-07-14. Estimated completion is 2017-02-08.

What conditions does trial NCT02100228 study?

This clinical trial studies the following conditions: Atrial Fibrillation.

What interventions are being tested in trial NCT02100228?

The interventions under investigation include: Apixaban (DRUG), Parenteral heparin and/or oral Vitamin K antagonist (DRUG).

Who is sponsoring clinical trial NCT02100228?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02100228 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.