Edoxaban Compared to Standard Care After Heart Valve Replacement Using a Catheter in Patients With Atrial Fibrillation (ENVISAGE-TAVI AF)

Completed · Phase 3

Conditions studied: Atrial Fibrillation

In brief

When the upper chambers of a person's heart receive or generate irregular electrical signals, it causes abnormal rhythm in the heartbeat. This is called atrial fibrillation. Atrial fibrillation goes along with blood clots that may cause mainly strokes and less often other diseases, such as a heart attack. Some patients with atrial fibrillation have other heart disease, such as heart valves that may need to be replaced using catheters. Often doctors give patients drugs that reduce those blood clots. These are either vitamin K antagonist (VKA) or direct anticoagulants, such as edoxaban. In these patients, it is unclear which of the drugs is better for reducing stroke without increasing severe bleedings.

Key facts

Study ID

NCT02943785

Run by

Daiichi Sankyo

People needed

1426

Starts

2017-03-21

Expected to finish

2021-02-28

Last updated by the study team

2022-03-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meets protocol-specified criteria for qualification and contraception
• Is willing and able to comply with any restrictions related food, drink and medications
• Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

You may not qualify if…

• Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
• Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
• the safety or well-being of the participant or study staff
• the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
• the analysis of results

Where it is running

• University of Arizona Sarver Heart Center — Tucson, Arizona, United States
• Arkansas Site Management Services — Little Rock, Arkansas, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Cedar-Sinai Heart Institute — Los Angeles, California, United States
• UCLA Cardiovascular Center — Los Angeles, California, United States
• University of California - San Francisco — San Francisco, California, United States
• Santa Barbara Cottage Hospital — Santa Barbara, California, United States
• Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Medical Facility Associates — Washington D.C., District of Columbia, United States
• Cardiology Associate Research — Daytona Beach, Florida, United States
• International Research Partners, LLC. — Doral, Florida, United States
• Memorial Healthcare Systems — Hollywood, Florida, United States
• UF Health Jacksonville — Jacksonville, Florida, United States
• Watson Clinic Center for Research — Lakeland, Florida, United States
• Tallahassee Research Institute, Inc. — Tallahassee, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Carle Foundation Hospital — Urbana, Illinois, United States
• St. Vincent Heart Center — Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Maine Medical Center — Scarborough, Maine, United States
• Washington Adventist Hospital — Takoma Park, Maryland, United States
• Baystate Health — Springfield, Massachusetts, United States
• University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States
• Sparrow Clinical Research Institute — Lansing, Michigan, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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