Apixaban Evaluation of Interrupted Or Uninterrupted Anticoagulation for Ablation of Atrial Fibrillation

NCT02608099 | Completed Phase 4 Results

• 1 other identifier: CV185-373
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 19

Brief Summary

The purpose of the prospective, randomized cohort in this study is to assess the safety and efficacy of 2 apixaban treatment strategies (uninterrupted versus interrupted) in subjects planned to undergo catheter ablation for the treatment of non-valvular atrial fibrillation (NVAF). Simultaneously, a retrospective cohort of 300 warfarin-treated individuals, identified by chart review, who are matched to the prospective randomized subjects, will be identified. The purpose of the retrospective warfarin cohort is to compare the efficacy and safety of warfarin(the current clinical practice) to that of apixaban (uninterrupted, interrupted, combined uninterrupted and interrupted).

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation; Non-valvular atrial fibrillation; Catheter ablation; Apixaban; Warfarin; Harvard Clinical Research Institute

Outcome Measures

Primary Outcomes (2)

• Number of Patients With Clinically-Significant Bleeding

  Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher.

  Randomization to 1 month post catheter ablation

• Number of Patients With Thrombotic Events

  Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events.

  Randomization to 1 month post catheter ablation

Secondary Outcomes (2)

• Number of Patients With Composite of Major Bleeding and Thrombotic Events

  Randomization to 1 month post catheter ablation

• Number of Patients With Composite of Clinically Significant Bleeding and Thrombotic Events

  Randomization to 1 month post catheter ablation

Other Outcomes (12)

• Number of Patients With Clinically-Significant Bleeding

  Enrollment to 1 month post catheter ablation

• Number of Patients With Major Bleeding

  Randomization to 1 month post catheter ablation

• Number of Patients With Major Bleeding

  Enrollment to 1 month post catheter ablation

Study Arms (2)

Interrupted apixaban

ACTIVE COMPARATOR

Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.

Drug: Interrupted apixaban

Uninterrupted apixaban

EXPERIMENTAL

Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.

Drug: Uninterrupted apixaban

Interventions

Interrupted apixaban DRUG

Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.

Also known as: Interrupted Eliquis

Interrupted apixaban

Uninterrupted apixaban DRUG

Intervention description: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.

Also known as: Uninterrupted Eliquis

Uninterrupted apixaban

Eligibility Criteria

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

You may qualify if:

• Signed informed consent.
• \>18 years of age.
• NVAF with planned catheter ablation treatment.
• Planned anticoagulant treatment for at least 1 month after the index procedure.
• Subject agrees to all required follow-up procedures and visits.
• For women of childbearing potential (WOCBP):
• Must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug.
• Must not be breastfeeding
• Must agree to follow instructions for method(s) of contraception for a total of 33 days post-treatment completion.
• Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for a total of 93 days post-treatment completion.
• Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However, WOCBP must still undergo pregnancy testing as described in this section.

You may not qualify if:

• History of significant bleeding diathesis or coagulopathy or inability to accept blood transfusions.
• Known hypersensitivity or contraindication to heparin or apixaban.
• Subjects with mechanical prosthetic heart valves.
• History of cerebrovascular accident or transient ischemic attach (TIA) within the last 6 months.
• Prior intracranial hemorrhage.
• End-stage renal failure (creatinine clearance rate \<15 mL/minute or on dialysis treatment).
• Hepatic disease associated with coagulopathy.
• Current or expected systemic treatment with strong dual inducers of CYP3A4 and P-glycoprotein (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort).
• Current or expected systemic treatment with dual antiplatelet therapy, other anticoagulants, or fibrinolytics.
• Planned or expected surgery, or other invasive procedure that would require interruption of anticoagulation within 1 month of the catheter ablation procedure.
• Currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
• Co-morbid condition(s) that could limit the subject's ability to participate in the trial or to comply with follow-up requirements, or that could impact the scientific integrity of the trial.
• Platelet count ≤100,000/mm3.
• Hemoglobin level \<9 g/dL.
• Any active bleeding.

Sponsors & Collaborators

• Baim Institute for Clinical Research: lead
• Bristol-Myers Squibb: collaborator

Study Sites (19)

Site 0020

Huntsville, Alabama, 35801, United States

Location

Site 0005

Mission Viejo, California, 92690, United States

Location

Site 0012

New Haven, Connecticut, 06501, United States

Location

Site 0011

Trumbull, Connecticut, 06611, United States

Location

Site 0016

Pensacola, Florida, 32501, United States

Location

Site 0014

West Des Moines, Iowa, 50266, United States

Location

Site 0018

Bangor, Maine, 04401, United States

Location

Site 0004

Scarborough, Maine, 04074, United States

Location

Site 0008

Boston, Massachusetts, 02118, United States

Location

Site 0001

Burlington, Massachusetts, 01805, United States

Location

Site 0006

Kansas City, Missouri, 64111, United States

Location

Site 0021

Omaha, Nebraska, 68131, United States

Location

Site 0019

Albuquerque, New Mexico, 87101, United States

Location

Site 0002

Toledo, Ohio, 43615, United States

Location

Site 0007

Oklahoma City, Oklahoma, 73104, United States

Location

Site 0009

Philadelphia, Pennsylvania, 19019, United States

Location

Site 0010

Charleston, South Carolina, 29401, United States

Location

Site 0017

Austin, Texas, 78705, United States

Location

Site 0003

Richmond, Virginia, 23219, United States

Location

Related Publications (2)

• Bawazeer GA, Alkofide HA, Alsharafi AA, Babakr NO, Altorkistani AM, Kashour TS, Miligkos M, AlFaleh KM, Al-Ansary LA. Interrupted versus uninterrupted anticoagulation therapy for catheter ablation in adults with arrhythmias. Cochrane Database Syst Rev. 2021 Oct 21;10(10):CD013504. doi: 10.1002/14651858.CD013504.pub2.

  PMID: 34674223 DERIVED

• Reynolds MR, Allison JS, Natale A, Weisberg IL, Ellenbogen KA, Richards M, Hsieh WH, Sutherland J, Cannon CP. A Prospective Randomized Trial of Apixaban Dosing During Atrial Fibrillation Ablation: The AEIOU Trial. JACC Clin Electrophysiol. 2018 May;4(5):580-588. doi: 10.1016/j.jacep.2017.11.005. Epub 2017 Dec 20.

  PMID: 29798783 DERIVED

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: Director of Trial Design and Development
• Organization: Baim Institute for Clinical Research

TrialDesignandDevelopmentStaff@baiminstitute.org

617-307-5200

Study Officials

• Matthew Reynolds, MD, MSc

  Lahey Hospital & Medical Center

  PRINCIPAL INVESTIGATOR

• Christopher P Cannon, MD

  Harvard Clinical Research Organization and Cardiovascular Division Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: November 9, 2015
• First Posted: November 18, 2015
• Study Start: November 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: March 17, 2020
• Results First Posted: March 17, 2020

Record last verified: 2020-03

Locations

US (19)