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

• Sponsor: Baim Institute for Clinical Research (Other)
• Overall Status: Completed
• CT.gov ID: NCT02608099
• Collaborator: Bristol-Myers Squibb (Industry)
• Enrollment: 300
• Locations: 19
• Arms: 2
• Duration (Months): 17
• Patients Per Site: 15.8
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Drug: Interrupted apixaban; Drug: Uninterrupted apixaban	Phase 4

Detailed Description

Prospective, Randomized Cohort

Subjects undergoing ablation for NVAF who meet all eligibility criteria and sign informed consent will be enrolled into the study. Subjects will be treated with apixaban for ≥21 days prior to the ablation procedure (for subjects already on apixaban for ≥21 days, it is not necessary to wait 21 days before the ablation procedure. Apixaban dose will be 5 mg b.i.d. per product label, or 2.5 mg b.i.d. in subjects with 2 or more of the following: age ≥80 years, body weight ≤60 kg, or serum creatinine ≥1.5 mg/dL.

Eligible subjects will then be randomized in a 1:1 ratio to 2 peri-procedural treatment strategies:

• Uninterrupted treatment: administer the evening apixaban dose on the day prior to the procedure; administer the morning apixaban dose on the day of the procedure; administer heparin bolus before transseptal puncture to maintain a target activated clotting time [ACT] > 300 seconds; administer the evening apixaban dose after the procedure if there were no peri-procedural complications that necessitate withholding anticoagulation for longer duration.

• Interrupted treatment: administer the evening apixaban dose on the day prior to the procedure; do not administer the morning apixaban dose on the day of the procedure; administer heparin bolus before transseptal puncture to maintain a target ACT > 300 seconds; administer the evening apixaban dose after the procedure if there were no peri-procedural complications that necessitate withholding anticoagulation for longer duration.

Randomization will take place prior to the procedure (on the day of the procedure or up to 3 days prior to the procedure) and will be stratified by site.

It is anticipated that up to 360 subjects may be enrolled in order to evaluate a total of 300 randomized subjects (150 subjects per treatment arm):

Randomized subjects will continue treatment with apixaban for 1 month post procedure.

Retrospective, Warfarin Cohort In addition, a chart review of 300 warfarin-treated patients who underwent catheter ablation for NVAF on or after September 1, 2013 in the enrolling centers and who have documented follow-up in the medical record for ≥ 30 days post-ablation procedure will be performed. Patient records for warfarin-treated individuals who meet the applicable inclusion/exclusion criteria and who are matched 1:1 to a subject in the prospective, randomized cohort for age (+/- 5 years), gender and atrial fibrillation (AF) type (paroxysmal vs. persistent), will be identified. Sites will document key demographic and outcome variables. This review will be performed in a blinded manner such that site personnel are blinded to the outcome of each retrospective subject during the subject selection process. Only pre-existing data will be collected for the analysis of this cohort.

Study Design

• Study Type: Interventional
• Actual Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Apixaban Evaluation of Interrupted Or Uninterrupted Anticoagulation for Ablation of Atrial Fibrillation
• Study Start Date: Nov 1, 2015
• Actual Primary Completion Date: Apr 1, 2017
• Actual Study Completion Date: Apr 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Interrupted apixaban 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; 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.; Other Names: Interrupted Eliquis
Experimental: Uninterrupted apixaban 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; 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.; Other Names: Uninterrupted Eliquis

Outcome Measures

Primary Outcome Measures

1. Number of Patients With Clinically-Significant Bleeding [Randomization to 1 month post catheter ablation]

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

2. Number of Patients With Thrombotic Events [Randomization to 1 month post catheter ablation]

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

Secondary Outcome Measures

1. Number of Patients With Composite of Major Bleeding and Thrombotic Events [Randomization to 1 month post catheter ablation]

   Major bleeding was defined as bleeding meeting BARC criteria type 3 or higher. Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events.

2. Number of Patients With Composite of Clinically Significant Bleeding and Thrombotic Events [Randomization to 1 month post catheter ablation]

   Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events. Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher.

Other Outcome Measures

1. Number of Patients With Clinically-Significant Bleeding [Enrollment to 1 month post catheter ablation]

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

2. Number of Patients With Major Bleeding [Randomization to 1 month post catheter ablation]

   Major bleeding was defined as bleeding meeting BARC criteria type 3 or higher.

3. Number of Patients With Major Bleeding [Enrollment to 1 month post catheter ablation]

   Major bleeding was defined as bleeding meeting BARC criteria type 3 or higher.

4. Number of Patients With Thrombotic Events [Enrollment to 1 month post catheter ablation]

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

5. Number of Patients With Composite of Clinically Significant Bleeding and Thrombotic Events [Enrollment to 1 month post catheter ablation]

   Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events. Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher.

6. Number of Patients With Composite of Major Bleeding and Thrombotic Events [Enrollment to 1 month post catheter ablation]

   Thrombotic events are defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events. Major bleeding is defined as bleeding meeting BARC criteria type 3 or higher.

7. Number of Patients With TIAs or Non-Hemorrhagic Strokes [Enrollment to 1 month post catheter ablation]

   Number of Patients who had TIAs or non-hemorrhagic strokes.

8. Number of Patients With TIAs or Non-Hemorrhagic Strokes [Randomization to 1 month post catheter ablation]

   This measurement includes TIAs or non-hemorrhagic strokes.

9. Number of Patients With Death [Enrollment to 1 month post catheter ablation]

   Death is included in this measurement.

10. Number of Patients With Cardiovascular Death [Enrollment to 1 month post catheter ablation]

    Cardiovascular death is included in this measurement.

11. Number of Patients With Death [Randomization to 1 month post catheter ablation]

    Death is included in this measurement.

12. Number of Patients With Cardiovascular Death [Randomization to 1 month post catheter ablation]

    Cardiovascular death is included in this measurement.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Signed informed consent.

2. 18 years of age.

3. NVAF with planned catheter ablation treatment.

4. Planned anticoagulant treatment for at least 1 month after the index procedure.

5. Subject agrees to all required follow-up procedures and visits.

6. 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.

1. 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.

2. 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.

Exclusion Criteria:

1. History of significant bleeding diathesis or coagulopathy or inability to accept blood transfusions.

2. Known hypersensitivity or contraindication to heparin or apixaban.

3. Subjects with mechanical prosthetic heart valves.

4. History of cerebrovascular accident or transient ischemic attach (TIA) within the last 6 months.

5. Prior intracranial hemorrhage.

6. End-stage renal failure (creatinine clearance rate <15 mL/minute or on dialysis treatment).

7. Hepatic disease associated with coagulopathy.

8. Current or expected systemic treatment with strong dual inducers of CYP3A4 and P-glycoprotein (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort).

9. Current or expected systemic treatment with dual antiplatelet therapy, other anticoagulants, or fibrinolytics.

10. Planned or expected surgery, or other invasive procedure that would require interruption of anticoagulation within 1 month of the catheter ablation procedure.

11. 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.

12. 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.

13. Platelet count ≤100,000/mm3.

14. Hemoglobin level <9 g/dL.

15. Any active bleeding.

16. Prisoners or subjects who are involuntarily incarcerated.

17. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site 0020	Huntsville	Alabama	United States	35801
2	Site 0005	Mission Viejo	California	United States	92690
3	Site 0012	New Haven	Connecticut	United States	06501
4	Site 0011	Trumbull	Connecticut	United States	06611
5	Site 0016	Pensacola	Florida	United States	32501
6	Site 0014	West Des Moines	Iowa	United States	50266
7	Site 0018	Bangor	Maine	United States	04401
8	Site 0004	Scarborough	Maine	United States	04074
9	Site 0008	Boston	Massachusetts	United States	02118
10	Site 0001	Burlington	Massachusetts	United States	01805
11	Site 0006	Kansas City	Missouri	United States	64111
12	Site 0021	Omaha	Nebraska	United States	68131
13	Site 0019	Albuquerque	New Mexico	United States	87101
14	Site 0002	Toledo	Ohio	United States	43615
15	Site 0007	Oklahoma City	Oklahoma	United States	73104
16	Site 0009	Philadelphia	Pennsylvania	United States	19019
17	Site 0010	Charleston	South Carolina	United States	29401
18	Site 0017	Austin	Texas	United States	78705
19	Site 0003	Richmond	Virginia	United States	23219

Sponsors and Collaborators

• Baim Institute for Clinical Research
• Bristol-Myers Squibb

Investigators

• Principal Investigator: 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

Study Documents (Full-Text)

• Statistical Analysis Plan - Oct 28, 2016
• Study Protocol - Sep 2, 2015

More Information

Publications

None provided.

• Responsible Party: Baim Institute for Clinical Research
• ClinicalTrials.gov Identifier: NCT02608099
• Other Study ID Numbers: CV185-373
• First Posted: Nov 18, 2015
• Last Update Posted: Mar 17, 2020
• Last Verified: Mar 1, 2020

• Keywords provided by Baim Institute for Clinical Research: Atrial fibrillation; Non-valvular atrial fibrillation; Catheter ablation; Apixaban; Warfarin; Harvard Clinical Research Institute
• Additional relevant MeSH terms: Atrial Fibrillation; Apixaban

Study Results

Participant Flow

Arm/Group Title	Interrupted Apixaban	Uninterrupted Apixaban
Arm/Group Description	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. Interrupted apixaban: 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.	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. Uninterrupted apixaban: 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.
Period Title: Overall Study
STARTED	148	152
Safety	149	151
COMPLETED	145	150
NOT COMPLETED	3	2

Baseline Characteristics

Arm/Group Title	Interrupted Apixaban	Uninterrupted Apixaban	Total
Arm/Group Description	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. Interrupted apixaban: 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.	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. Uninterrupted apixaban: 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.	Total of all reporting groups
Overall Participants	145	150	295
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	64.3 (10.3)	62.8 (9.9)	63.5 (10.1)
Sex: Female, Male (Count of Participants)
Female	48 33.1%	49 32.7%	97 32.9%
Male	97 66.9%	101 67.3%	198 67.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 0.7%	2 1.3%	3 1%
Not Hispanic or Latino	134 92.4%	143 95.3%	277 93.9%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 0.7%	1 0.3%
Asian	2 1.4%	0 0%	2 0.7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	4 2.8%	2 1.3%	6 2%
White	133 91.7%	141 94%	274 92.9%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Body Mass Index (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	30.46 (5.607)	30.58 (6.441)	30.52 (6.036)

Outcome Measures

1. Primary Outcome

Title	Number of Patients With Clinically-Significant Bleeding
Description	Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher.
Time Frame	Randomization to 1 month post catheter ablation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interrupted Apixaban	Uninterrupted Apixaban
Arm/Group Description	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. Interrupted apixaban: 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.	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. Uninterrupted apixaban: 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.
Measure Participants	145	150
Count of Participants [Participants]	14 9.7%	17 11.3%

2. Primary Outcome

Title	Number of Patients With Thrombotic Events
Description	Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events.
Time Frame	Randomization to 1 month post catheter ablation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interrupted Apixaban	Uninterrupted Apixaban
Arm/Group Description	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. Interrupted apixaban: 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.	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. Uninterrupted apixaban: 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.
Measure Participants	145	150
Count of Participants [Participants]	0 0%	0 0%

3. Secondary Outcome

Title	Number of Patients With Composite of Major Bleeding and Thrombotic Events
Description	Major bleeding was defined as bleeding meeting BARC criteria type 3 or higher. Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events.
Time Frame	Randomization to 1 month post catheter ablation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interrupted Apixaban	Uninterrupted Apixaban
Arm/Group Description	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. Interrupted apixaban: 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.	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. Uninterrupted apixaban: 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.
Measure Participants	145	150
Count of Participants [Participants]	3 2.1%	2 1.3%

4. Secondary Outcome

Title	Number of Patients With Composite of Clinically Significant Bleeding and Thrombotic Events
Description	Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events. Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher.
Time Frame	Randomization to 1 month post catheter ablation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interrupted Apixaban	Uninterrupted Apixaban
Arm/Group Description	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. Interrupted apixaban: 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.	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. Uninterrupted apixaban: 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.
Measure Participants	145	150
Count of Participants [Participants]	14 9.7%	17 11.3%

5. Other Pre-specified Outcome

Title	Number of Patients With Clinically-Significant Bleeding
Description	Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher.
Time Frame	Enrollment to 1 month post catheter ablation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interrupted Apixaban	Uninterrupted Apixaban
Arm/Group Description	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. Interrupted apixaban: 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.	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. Uninterrupted apixaban: 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.
Measure Participants	145	150
Count of Participants [Participants]	17 11.7%	17 11.3%

6. Other Pre-specified Outcome

Title	Number of Patients With Major Bleeding
Description	Major bleeding was defined as bleeding meeting BARC criteria type 3 or higher.
Time Frame	Randomization to 1 month post catheter ablation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interrupted Apixaban	Uninterrupted Apixaban
Arm/Group Description	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. Interrupted apixaban: 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.	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. Uninterrupted apixaban: 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.
Measure Participants	145	150
Count of Participants [Participants]	3 2.1%	2 1.3%

7. Other Pre-specified Outcome

Title	Number of Patients With Major Bleeding
Description	Major bleeding was defined as bleeding meeting BARC criteria type 3 or higher.
Time Frame	Enrollment to 1 month post catheter ablation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interrupted Apixaban	Uninterrupted Apixaban
Arm/Group Description	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. Interrupted apixaban: 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.	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. Uninterrupted apixaban: 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.
Measure Participants	145	150
Count of Participants [Participants]	3 2.1%	2 1.3%

8. Other Pre-specified Outcome

Title	Number of Patients With Thrombotic Events
Description	Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events.
Time Frame	Enrollment to 1 month post catheter ablation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interrupted Apixaban	Uninterrupted Apixaban
Arm/Group Description	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. Interrupted apixaban: 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.	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. Uninterrupted apixaban: 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.
Measure Participants	145	150
Count of Participants [Participants]	0 0%	0 0%

9. Other Pre-specified Outcome

Title	Number of Patients With Composite of Clinically Significant Bleeding and Thrombotic Events
Description	Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events. Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher.
Time Frame	Enrollment to 1 month post catheter ablation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interrupted Apixaban	Uninterrupted Apixaban
Arm/Group Description	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. Interrupted apixaban: 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.	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. Uninterrupted apixaban: 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.
Measure Participants	145	150
Count of Participants [Participants]	14 9.7%	17 11.3%

10. Other Pre-specified Outcome

Title	Number of Patients With Composite of Major Bleeding and Thrombotic Events
Description	Thrombotic events are defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events. Major bleeding is defined as bleeding meeting BARC criteria type 3 or higher.
Time Frame	Enrollment to 1 month post catheter ablation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interrupted Apixaban	Uninterrupted Apixaban
Arm/Group Description	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. Interrupted apixaban: 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.	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. Uninterrupted apixaban: 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.
Measure Participants	145	150
Count of Participants [Participants]	3 2.1%	2 1.3%

11. Other Pre-specified Outcome

Title	Number of Patients With TIAs or Non-Hemorrhagic Strokes
Description	Number of Patients who had TIAs or non-hemorrhagic strokes.
Time Frame	Enrollment to 1 month post catheter ablation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interrupted Apixaban	Uninterrupted Apixaban
Arm/Group Description	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. Interrupted apixaban: 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.	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. Uninterrupted apixaban: 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.
Measure Participants	145	150
Count of Participants [Participants]	1 0.7%	1 0.7%

12. Other Pre-specified Outcome

Title	Number of Patients With TIAs or Non-Hemorrhagic Strokes
Description	This measurement includes TIAs or non-hemorrhagic strokes.
Time Frame	Randomization to 1 month post catheter ablation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interrupted Apixaban	Uninterrupted Apixaban
Arm/Group Description	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. Interrupted apixaban: 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.	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. Uninterrupted apixaban: 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.
Measure Participants	145	150
Count of Participants [Participants]	1 0.7%	1 0.7%

13. Other Pre-specified Outcome

Title	Number of Patients With Death
Description	Death is included in this measurement.
Time Frame	Enrollment to 1 month post catheter ablation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interrupted Apixaban	Uninterrupted Apixaban
Arm/Group Description	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. Interrupted apixaban: 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.	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. Uninterrupted apixaban: 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.
Measure Participants	145	150
Count of Participants [Participants]	0 0%	0 0%

14. Other Pre-specified Outcome

Title	Number of Patients With Cardiovascular Death
Description	Cardiovascular death is included in this measurement.
Time Frame	Enrollment to 1 month post catheter ablation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interrupted Apixaban	Uninterrupted Apixaban
Arm/Group Description	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. Interrupted apixaban: 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.	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. Uninterrupted apixaban: 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.
Measure Participants	145	150
Count of Participants [Participants]	0 0%	0 0%

15. Other Pre-specified Outcome

Title	Number of Patients With Death
Description	Death is included in this measurement.
Time Frame	Randomization to 1 month post catheter ablation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interrupted Apixaban	Uninterrupted Apixaban
Arm/Group Description	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. Interrupted apixaban: 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.	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. Uninterrupted apixaban: 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.
Measure Participants	145	150
Count of Participants [Participants]	0 0%	0 0%

16. Other Pre-specified Outcome

Title	Number of Patients With Cardiovascular Death
Description	Cardiovascular death is included in this measurement.
Time Frame	Randomization to 1 month post catheter ablation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interrupted Apixaban	Uninterrupted Apixaban
Arm/Group Description	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. Interrupted apixaban: 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.	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. Uninterrupted apixaban: 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.
Measure Participants	145	150
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Time Frame	1 Month
Adverse Event Reporting Description	Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.
Arm/Group Title	Interrupted Apixaban		Uninterrupted Apixaban
Arm/Group Description	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. Interrupted apixaban: 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. A total of 149 patients were included in the "Interrupted Apixaban" arm from the safety population (patients were analyzed under the actual treatment received).		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. Uninterrupted apixaban: 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. A total of 151 patients were included in the "Uninterrupted Apixaban" arm from the safety population (patients were analyzed under the actual treatment received).
All Cause Mortality
	Interrupted Apixaban		Uninterrupted Apixaban
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/149 (0%)		0/151 (0%)
Serious Adverse Events
	Interrupted Apixaban		Uninterrupted Apixaban
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/149 (9.4%)		15/151 (9.9%)
Cardiac disorders
Arrhythmia Supraventricular	2/149 (1.3%)		1/151 (0.7%)
Atrial Fibrillation	2/149 (1.3%)		3/151 (2%)
Atrial Flutter	2/149 (1.3%)		1/151 (0.7%)
Cardiac Failure Congestive	1/149 (0.7%)		0/151 (0%)
Cardiac Perforation	0/149 (0%)		1/151 (0.7%)
Cardiogenic Shock	0/149 (0%)		1/151 (0.7%)
Sinus Arrest	1/149 (0.7%)		0/151 (0%)
Eye disorders
Blindness Transient	0/149 (0%)		1/151 (0.7%)
Gastrointestinal disorders
Gastrooesophageal Reflux Disease	0/149 (0%)		1/151 (0.7%)
General disorders
Catheter Site Haemorrhage	1/149 (0.7%)		0/151 (0%)
Catheter Site Pain	1/149 (0.7%)		0/151 (0%)
Infections and infestations
Pneumonia Mycoplasmal	1/149 (0.7%)		0/151 (0%)
Sepsis	0/149 (0%)		1/151 (0.7%)
Urinary Tract Infection	0/149 (0%)		2/151 (1.3%)
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm	1/149 (0.7%)		1/151 (0.7%)
Metabolism and nutrition disorders
Fluid Overload	1/149 (0.7%)		0/151 (0%)
Hypervolaemia	1/149 (0.7%)		0/151 (0%)
Musculoskeletal and connective tissue disorders
Fistula	0/149 (0%)		1/151 (0.7%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma	0/149 (0%)		1/151 (0.7%)
Nervous system disorders
Migraine	0/149 (0%)		1/151 (0.7%)
Presyncope	0/149 (0%)		1/151 (0.7%)
Renal and urinary disorders
Haematuria	0/149 (0%)		1/151 (0.7%)
Urinary Retention	1/149 (0.7%)		0/151 (0%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	1/149 (0.7%)		0/151 (0%)
Dyspnoea Exertional	1/149 (0.7%)		0/151 (0%)
Pharyngeal Haemorrhage	0/149 (0%)		1/151 (0.7%)
Vascular disorders
Hypotension	0/149 (0%)		2/151 (1.3%)
Other (Not Including Serious) Adverse Events
	Interrupted Apixaban		Uninterrupted Apixaban
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	72/149 (48.3%)		75/151 (49.7%)
Blood and lymphatic system disorders
Leukocytosis	0/149 (0%)		1/151 (0.7%)
Spontaneous haemorrhage	0/149 (0%)		1/151 (0.7%)
Cardiac disorders
Angina pectoris	2/149 (1.3%)		1/151 (0.7%)
Arrhythmia supraventricular	10/149 (6.7%)		9/151 (6%)
Atrial fibrillation	13/149 (8.7%)		7/151 (4.6%)
Atrial flutter	7/149 (4.7%)		3/151 (2%)
Atrial thrombosis	1/149 (0.7%)		0/151 (0%)
Atrioventricular block first degree	1/149 (0.7%)		0/151 (0%)
Cardiac failure congestive	1/149 (0.7%)		0/151 (0%)
Cardiac perforation	0/149 (0%)		1/151 (0.7%)
Cardiogenic shock	0/149 (0%)		1/151 (0.7%)
Cardiomyopathy	0/149 (0%)		1/151 (0.7%)
Coronary artery disease	1/149 (0.7%)		0/151 (0%)
Diastolic dysfunction	1/149 (0.7%)		0/151 (0%)
Mitral valve incompetence	0/149 (0%)		1/151 (0.7%)
Mitral valve stenosis	0/149 (0%)		1/151 (0.7%)
Palpitations	1/149 (0.7%)		0/151 (0%)
Pericardial effusion	0/149 (0%)		3/151 (2%)
Pericarditis	1/149 (0.7%)		2/151 (1.3%)
Sinus arrest	1/149 (0.7%)		0/151 (0%)
Sinus bradycardia	0/149 (0%)		3/151 (2%)
Sinus tachycardia	1/149 (0.7%)		0/151 (0%)
Ear and labyrinth disorders
Ear pain	1/149 (0.7%)		0/151 (0%)
Middle ear effusion	0/149 (0%)		1/151 (0.7%)
Eye disorders
Blindness transient	0/149 (0%)		1/151 (0.7%)
Eye irritation	0/149 (0%)		1/151 (0.7%)
Eye pain	0/149 (0%)		1/151 (0.7%)
Visual impairment	1/149 (0.7%)		0/151 (0%)
Gastrointestinal disorders
Abdominal distension	0/149 (0%)		1/151 (0.7%)
Constipation	0/149 (0%)		1/151 (0.7%)
Dental caries	1/149 (0.7%)		0/151 (0%)
Diarrhoea	1/149 (0.7%)		0/151 (0%)
Gastrooesophageal reflux disease	0/149 (0%)		3/151 (2%)
Haematemesis	1/149 (0.7%)		0/151 (0%)
Lip swelling	1/149 (0.7%)		0/151 (0%)
Mouth haemorrhage	0/149 (0%)		1/151 (0.7%)
Nausea	7/149 (4.7%)		7/151 (4.6%)
General disorders
Catheter site bruise	3/149 (2%)		3/151 (2%)
Catheter site discharge	2/149 (1.3%)		3/151 (2%)
Catheter site haematoma	5/149 (3.4%)		2/151 (1.3%)
Catheter site haemorrhage	8/149 (5.4%)		5/151 (3.3%)
Catheter site pain	7/149 (4.7%)		3/151 (2%)
Catheter site swelling	1/149 (0.7%)		0/151 (0%)
Fatigue	1/149 (0.7%)		1/151 (0.7%)
Infusion site pain	1/149 (0.7%)		0/151 (0%)
Non-cardiac chest pain	6/149 (4%)		6/151 (4%)
Oedema peripheral	2/149 (1.3%)		5/151 (3.3%)
Pain	1/149 (0.7%)		1/151 (0.7%)
Pyrexia	1/149 (0.7%)		0/151 (0%)
Infections and infestations
Catheter site infection	0/149 (0%)		1/151 (0.7%)
Diverticulitis	0/149 (0%)		1/151 (0.7%)
Incision site infection	0/149 (0%)		1/151 (0.7%)
Pneumonia mycoplasmal	1/149 (0.7%)		0/151 (0%)
Sepsis	0/149 (0%)		1/151 (0.7%)
Sinusitis	1/149 (0.7%)		0/151 (0%)
Upper respiratory tract infection	1/149 (0.7%)		0/151 (0%)
Urinary tract infection	2/149 (1.3%)		3/151 (2%)
Injury, poisoning and procedural complications
Cardiac procedure complication	0/149 (0%)		1/151 (0.7%)
Contusion	0/149 (0%)		1/151 (0.7%)
Incision site haemorrhage	1/149 (0.7%)		0/151 (0%)
Incision site pain	2/149 (1.3%)		0/151 (0%)
Muscle strain	0/149 (0%)		1/151 (0.7%)
Periorbital haemorrhage	1/149 (0.7%)		1/151 (0.7%)
Procedural headache	0/149 (0%)		1/151 (0.7%)
Procedural hypotension	1/149 (0.7%)		0/151 (0%)
Procedural nausea	1/149 (0.7%)		0/151 (0%)
Procedural vomiting	1/149 (0.7%)		0/151 (0%)
Vascular pseudoaneurysm	1/149 (0.7%)		2/151 (1.3%)
Investigations
Blood creatinine increased	0/149 (0%)		1/151 (0.7%)
Electrocardiogram QT prolonged	1/149 (0.7%)		1/151 (0.7%)
Haemoglobin decreased	1/149 (0.7%)		0/151 (0%)
International normalised ratio increased	1/149 (0.7%)		0/151 (0%)
Metabolism and nutrition disorders
Decreased appetite	1/149 (0.7%)		0/151 (0%)
Fluid overload	2/149 (1.3%)		3/151 (2%)
Fluid retention	3/149 (2%)		0/151 (0%)
Hyperglycaemia	1/149 (0.7%)		0/151 (0%)
Hypervolaemia	1/149 (0.7%)		0/151 (0%)
Hypokalaemia	2/149 (1.3%)		1/151 (0.7%)
Musculoskeletal and connective tissue disorders
Arthralgia	2/149 (1.3%)		2/151 (1.3%)
Back pain	5/149 (3.4%)		0/151 (0%)
Fistula	0/149 (0%)		1/151 (0.7%)
Muscle spasms	2/149 (1.3%)		1/151 (0.7%)
Musculoskeletal pain	2/149 (1.3%)		3/151 (2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma	0/149 (0%)		1/151 (0.7%)
Nervous system disorders
Dizziness	4/149 (2.7%)		4/151 (2.6%)
Headache	3/149 (2%)		4/151 (2.6%)
Hypoaesthesia	0/149 (0%)		1/151 (0.7%)
Migraine	1/149 (0.7%)		0/151 (0%)
Paraesthesia	1/149 (0.7%)		2/151 (1.3%)
Presyncope	1/149 (0.7%)		1/151 (0.7%)
Transient ischaemic attack	2/149 (1.3%)		0/151 (0%)
Tremor	1/149 (0.7%)		0/151 (0%)
Psychiatric disorders
Anxiety	1/149 (0.7%)		2/151 (1.3%)
Depression	0/149 (0%)		1/151 (0.7%)
Renal and urinary disorders
Haematuria	1/149 (0.7%)		1/151 (0.7%)
Haemorrhage urinary tract	0/149 (0%)		1/151 (0.7%)
Pollakiuria	1/149 (0.7%)		0/151 (0%)
Urinary retention	1/149 (0.7%)		0/151 (0%)
Reproductive system and breast disorders
Gynaecomastia	0/149 (0%)		1/151 (0.7%)
Pelvic pain	0/149 (0%)		1/151 (0.7%)
Respiratory, thoracic and mediastinal disorders
Atelectasis	0/149 (0%)		1/151 (0.7%)
Cough	2/149 (1.3%)		1/151 (0.7%)
Dyspnoea	4/149 (2.7%)		5/151 (3.3%)
Dyspnoea exertional	1/149 (0.7%)		0/151 (0%)
Haemoptysis	1/149 (0.7%)		0/151 (0%)
Hyperventilation	0/149 (0%)		1/151 (0.7%)
Oropharyngeal pain	2/149 (1.3%)		1/151 (0.7%)
Pharyngeal haemorrhage	0/149 (0%)		1/151 (0.7%)
Pleural effusion	0/149 (0%)		1/151 (0.7%)
Skin and subcutaneous tissue disorders
Dermatitis allergic	0/149 (0%)		1/151 (0.7%)
Rash	0/149 (0%)		1/151 (0.7%)
Rash pruritic	1/149 (0.7%)		0/151 (0%)
Vascular disorders
Aortic stenosis	0/149 (0%)		1/151 (0.7%)
Deep vein thrombosis	1/149 (0.7%)		0/151 (0%)
Hypertension	3/149 (2%)		2/151 (1.3%)
Hypotension	0/149 (0%)		4/151 (2.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.