Oral Anticoagulation Therapy Pilot Study

NCT01959425 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: OAT-149
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to determine the safety of discontinuing oral anticoagulation therapy in high risk patients who have had a successful cardiac ablation and remain AF recurrence free for 3 months post ablation.

Conditions

Paroxysmal Atrial Fibrillation

Keywords

Anticoagulation; Oral; Paroxysmal atrial fibrillation; Patients post successful cardiac ablation; Symptomatic high-burden paroxysmal AF; 3 months post procedure; Remain free from AF recurrence

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Occurrence of Any Major Thromboembolic Event

  Composite endpoint represented by the occurrence of any major thromboembolic event (stroke \[i.e., ischemic, hemorrhagic or cryptogenic\] that is an acute onset of a focal neurologic deficit of presumed vascular origin lasting for ≥24 hours or resulting in death) or major hemorrhagic complication (major bleeding) during the 12-month Evaluation Period.

  12 months

Secondary Outcomes (7)

• Percentage of Participants With Minor Bleeds

  12 months

• Percentage of Participants Hospitalized With Any Thromboembolic or Major Hemorrhagic Event

  12 months

• Percentage of Expired Participants

  12 months

• Mean SF-36 Quality of Life Scores of Participants at Baseline, 3 Months, and 12 Months: Physical Component Summary (PCS)

  Baseline, 3 months, 12 months

• Mean SF-36 Quality of Life Scores of Participants at Baseline, 3 Months, and 12 Months: Mental Component Summary (MCS)

  Baseline, 3 months, 12 months

Study Arms (2)

Off OAT Group (Test)

EXPERIMENTAL

Discontinuation of OAT Therapy

Other: Off OAT Group (Test)

On OAT Group (Control)

OTHER

Continuation of OAT Therapy

Other: On OAT Group (Control)

Interventions

Off OAT Group (Test) OTHER

Discontinuation of OAT Therapy

Off OAT Group (Test)

On OAT Group (Control) OTHER

Continuation of OAT Therapy

On OAT Group (Control)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Successful cardiac ablation for AF
• Documented freedom from AF recurrence (symptomatic or asymptomatic arrhythmic recurrences lasting longer than 30 seconds) 3 months after successful cardiac ablation (AF recurrence during 3-month blanking period is excluded).
• Patient must have been on a commercially approved anticoagulation therapy for at least two (2) months prior to randomization in the OAT Study.
• CHADS2 score ≥ 2 or CHA2DS2-VASc score (≥3)
• Left ventricular ejection fraction \> 25%
• LA size \< 65
• High risk for thromboembolic events (i.e., CHADS2 score ≥ 2 or CHA2DS2-VASc score ≥ 3) and require OAT before undergoing cardiac ablation
• Able and willing to comply with all pre- and follow-up testing and requirements
• Signed informed consent form
• Age 18 years or older

You may not qualify if:

• OAT required for reasons not related to AF (i.e., prosthetic valve, PV stenosis, previous pulmonary embolism, presence of spontaneous echo contrast \[SEC\] at standard echo performed at 3-months follow-up).
• Any cardiac surgery within the past 60 days (2 months) or valvular cardiac surgical procedure at any time (i.e., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)
• Previous myocardial infarction (MI) or a percutaneous coronary intervention PCI within the past 3 months
• Awaiting cardiac transplantation or other cardiac surgery within the next 365 days (12 months)
• Documented left atrial thrombus
• Significant pulmonary disease, (e.g., restrictive pulmonary disease, constrictive or COPD) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms
• Significant medical problem that in the opinion of the investigator would preclude enrollment in this study
• Women who are pregnant (as evidenced by pregnancy test if pre-menopausal)
• Acute illness or active systemic infection or sepsis
• Unstable angina
• Contraindication to anticoagulation (i.e., heparin, warfarin or another commercially available anticoagulation medication)
• History of blood clotting or bleeding abnormalities
• Life expectancy less than 360 days (12 months)
• Uncontrolled Heart Failure or NYHA Class III or IV heart failure
• Enrollment in a clinical study evaluating another device or drug, within the past 6 months

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Stephanie Lyke
• Organization: Biosense Webster Inc.

SLyke@its.jnj.com

(949) 285-7966

Study Officials

• Andrea Natale, MD

  Texas Cardiac Arrhythmia Research Foundation

  PRINCIPAL INVESTIGATOR

• Antonio Raviele, MD

  Dell'Angelo Hospital

  PRINCIPAL INVESTIGATOR

• Michael Riley, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Karl Heinz Kuck, MD

  Hanseatisches Herzzentrum, Asklepios Klinik

  PRINCIPAL INVESTIGATOR

• Michel Haissaguerre, MD

  Hospital Cardiologigue du Haut-Leveque

  PRINCIPAL INVESTIGATOR

• Pierre Jais, MD

  Hospital Cardiologigue du Haut-Leveque

  PRINCIPAL INVESTIGATOR

• Sakis Themistoclakis, MD

  Dell'Angelo Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: October 10, 2013
• Study Start: April 17, 2013
• Primary Completion: October 7, 2019
• Study Completion: October 7, 2019
• Last Updated: February 4, 2025
• Results First Posted: December 17, 2020

Record last verified: 2025-01