Apixaban for Early Prevention of Recurrent Embolic Stroke and Hemorrhagic Transformation (AREST)

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ClinicalTrials.gov Identifier: NCT02283294

Recruitment Status : Completed

First Posted : November 5, 2014

Results First Posted : November 30, 2021

Last Update Posted : November 30, 2021

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

Bristol-Myers Squibb

Information provided by (Responsible Party):

University of South Florida

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
Conditions	Transient Ischemic Attack Stroke Atrial Fibrillation
Interventions	Drug: Apixaban Drug: Warfarin
Enrollment	91

Participant Flow

Recruitment Details
Pre-assignment Details	Ninety one patients were enrolled/consented into the study. Three patients of the 91 consented did not meet one or more of the inclusion/exclusion criteria and were excluded prior to randomization assignment.


Arm/Group Title	Apixaban	Warfarin
Arm/Group Description	Apixaban twice a day for 180 days w...	standard of care warfarin starting ...
Arm/Group Description	Apixaban twice a day for 180 days with drug initiation day 0-3 (TIA), day 3-5(small stroke) or day 7- 9 (medium stroke) respectively Apixaban	standard of care warfarin starting at day 7±5 (TIA) or day 14 ±5 (small to medium ischemic stroke). Warfarin
Period Title: Overall Study
Started ^[1]	41	47
Received Allocated Treatment Intervention	38	31
Completed	38	39
Not Completed	3	8
Reason Not Completed
Lost to Follow-up	1	1
Withdrawal by Subject	1	6
Protocol Violation	1	0
Thrombus on transesophageal echocardiogram	0	1
[1] Started indicates randomized to medication assignment. This does not necessarily indicate patient started the medication they were randomized to.

Baseline Characteristics

Arm/Group Title		Apixaban	Warfarin	Total
Arm/Group Description		Apixaban twice a day for 180 days w...	standard of care warfarin starting ...	Total of all reporting groups
Arm/Group Description		Apixaban twice a day for 180 days with drug initiation day 0-3 (TIA), day 3-5(small stroke) or day 7- 9 (medium stroke) respectively Apixaban	standard of care warfarin starting at day 7±5 (TIA) or day 14 ±5 (small to medium ischemic stroke). Warfarin	Total of all reporting groups
Overall Number of Baseline Participants		41	47	88
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	41 participants	47 participants	88 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	13 31.7%	12 25.5%	25 28.4%
	>=65 years	28 68.3%	35 74.5%	63 71.6%
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	41 participants	47 participants	88 participants
		72.6 (14.9)	74.3 (10.5)	73.5 (12.7)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	41 participants	47 participants	88 participants
	Female	26 63.4%	23 48.9%	49 55.7%
	Male	15 36.6%	24 51.1%	39 44.3%
Race/Ethnicity, Customized Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	41 participants	47 participants	88 participants
Black		7 17.1%	5 10.6%	12 13.6%
Hispanic		3 7.3%	6 12.8%	9 10.2%
Non-Hispanic White		31 75.6%	35 74.5%	66 75.0%
Other		0 0.0%	1 2.1%	1 1.1%
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	41 participants	47 participants	88 participants
United States		41	47	88
Hypertension Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	41 participants	47 participants	88 participants
		38 92.7%	46 97.9%	84 95.5%
Hyperlipidemia Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	41 participants	47 participants	88 participants
		24 58.5%	34 72.3%	58 65.9%
Coronary artery disease (CAD) ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	41 participants	47 participants	88 participants
		13 31.7%	18 38.3%	31 35.2%
		[1] Measure Description: Inclusive of history of untreated myocardial infarction, prior stenting, and prior coronary artery bypass graft. Does not include non-obstructive coronary disease.
Diabetes Mellitus Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	41 participants	47 participants	88 participants
		10 24.4%	22 46.8%	32 36.4%
Peripheral Artery Disease Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	41 participants	47 participants	88 participants
		4 9.8%	9 19.1%	13 14.8%
Prior Stroke Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	41 participants	47 participants	88 participants
		9 22.0%	10 21.3%	19 21.6%
Prosthetic Heart Valve / Valve Replacement Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	41 participants	47 participants	88 participants
		1 2.4%	4 8.5%	5 5.7%
Thyroid Disease Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	41 participants	47 participants	88 participants
		9 22.0%	13 27.7%	22 25.0%
Obstructive Sleep Apnea Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	41 participants	47 participants	88 participants
		5 12.2%	7 14.9%	12 13.6%
Congestive Heart Failure Symptoms Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	41 participants	47 participants	88 participants
		3 7.3%	9 19.1%	12 13.6%
Past Medical History Left Ventricular Ejection Fraction < 40% Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	41 participants	47 participants	88 participants
		6 14.6%	13 27.7%	19 21.6%
Chronic Kidney Disease Stage 3 ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	41 participants	47 participants	88 participants
		7 17.1%	15 31.9%	22 25.0%
		[1] Measure Description: glomerular filtration rate 30-59 mL/min/1.73 m^2
Chronic Kidney Disease Stage 4 ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	41 participants	47 participants	88 participants
		1 2.4%	2 4.3%	3 3.4%
		[1] Measure Description: glomerular filtration rate 15-29 mL/min/1.73 m^2
Chronic Kidney Disease Stage 5 ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	41 participants	47 participants	88 participants
		0 0.0%	0 0.0%	0 0.0%
		[1] Measure Description: glomerular filtration rate <15 or on dialysis
Transient Ischemic Attack Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	41 participants	47 participants	88 participants
		4 9.8%	3 6.4%	7 8.0%
Thromboembolism History Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	41 participants	47 participants	88 participants
		0 0.0%	3 6.4%	3 3.4%
New Onset Atrial Fibrillation Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	41 participants	47 participants	88 participants
		14 34.1%	14 29.8%	28 31.8%
Prior Use of Anticoagulation within last 3 months Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	41 participants	47 participants	88 participants
		3 7.3%	11 23.4%	14 15.9%
Former Tobacco Use History Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	41 participants	47 participants	88 participants
		10 24.4%	13 27.7%	23 26.1%
Former Alcohol Use History Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	41 participants	47 participants	88 participants
		1 2.4%	2 4.3%	3 3.4%
Former Illegal Drug Use History Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	41 participants	47 participants	88 participants
		1 2.4%	1 2.1%	2 2.3%
Height Mean (Standard Deviation) Unit of measure: m
	Number Analyzed	41 participants	47 participants	88 participants
		1.67 (0.11)	1.712 (0.14)	1.69 (0.13)
Weight Mean (Standard Deviation) Unit of measure: Kg
	Number Analyzed	41 participants	47 participants	88 participants
		82.10 (24.09)	88.08 (24.73)	85.29 (24.48)
Body Mass Index Mean (Standard Deviation) Unit of measure: Kg/m^2
	Number Analyzed	41 participants	47 participants	88 participants
		29.15 (6.68)	30.05 (7.60)	29.63 (7.16)
Body Surface Area Mean (Standard Deviation) Unit of measure: M^2
	Number Analyzed	41 participants	47 participants	88 participants
		1.90 (0.28)	1.99 (0.31)	1.95 (0.30)
Heart Rate Mean (Standard Deviation) Unit of measure: Bpm
	Number Analyzed	41 participants	47 participants	88 participants
		76.56 (14.46)	76.62 (16.61)	76.60 (15.56)
Systolic Blood Pressure Mean (Standard Deviation) Unit of measure: mmHg
	Number Analyzed	41 participants	47 participants	88 participants
		130.85 (18.64)	134.53 (20.13)	132.82 (19.43)
Current Tobacco Use ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	41 participants	47 participants	88 participants
		0 0.0%	4 8.5%	4 4.5%
		[1] Measure Description: Daily Use
Occasional Tobacco Use ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	41 participants	47 participants	88 participants
		0 0.0%	0 0.0%	0 0.0%
		[1] Measure Description: Less than daily user
Current Alcohol Use ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	41 participants	47 participants	88 participants
		6 14.6%	6 12.8%	12 13.6%
		[1] Measure Description: >/= 1 drink per day (1 drink = 12 ounces of regular beer, 5 ounces of wine, or 1.5 ounces of distilled spirits)
Occasional Alcohol Use ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	41 participants	47 participants	88 participants
		9 22.0%	8 17.0%	17 19.3%
		[1] Measure Description: <1 drink per day (1 drink = 12 ounces of regular beer, 5 ounces of wine, or 1.5 ounces of distilled spirits)
Diastolic Blood Pressure Mean (Standard Deviation) Unit of measure: mmHg
	Number Analyzed	41 participants	47 participants	88 participants
		74.07 (17.76)	70.26 (19.50)	72.03 (18.70)

Outcome Measures

1.Primary Outcome


Title	Number of Participants With a Composite Endpoint of Fatal Stroke, Recurrent Ischemic Stroke, or TIA
Description	[Not Specified]
Description	[Not Specified]
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Apixaban	Warfarin
Arm/Group Description:	Apixaban twice a day for 180 days w...	Standard of care warfarin starting ...
Arm/Group Description:	Apixaban twice a day for 180 days with drug initiation day 0-3 (TIA), day 3-5(small stroke) or day 7- 9 (medium stroke) respectively Apixaban	Standard of care warfarin starting at day 7±5 (TIA) or day 14 ±5 (small to medium ischemic stroke). Warfarin
Overall Number of Participants Analyzed	41	47
Measure Type: Count of Participants Unit of Measure: Participants
	7 17.1%	12 25.5%

2.Secondary Outcome


Title	Number of Participants With an Intracranial Hemorrhage Assessed by MRI/CT
Description	[Not Specified]
Description	[Not Specified]
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Apixaban	Warfarin
Arm/Group Description:	Apixaban twice a day for 180 days w...	standard of care warfarin starting ...
Arm/Group Description:	Apixaban twice a day for 180 days with drug initiation day 0-3 (TIA), day 3-5(small stroke) or day 7- 9 (medium stroke) respectively Apixaban	standard of care warfarin starting at day 7±5 (TIA) or day 14 ±5 (small to medium ischemic stroke). Warfarin
Overall Number of Participants Analyzed	41	47
Measure Type: Count of Participants Unit of Measure: Participants
	5 12.2%	6 12.8%

Adverse Events

Time Frame	210 +/- 10 days
Adverse Event Reporting Description	Adverse event assessment was performed at each of the patient follow up visits at baseline, day 14, day 30, day 60, day 120, day 150, day 180, and day 210. At each follow up visit, patients were evaluated by study coordinator, cardiologist, and neurologist. A physical exam, patient interview, electrocardiogram, and review of patient records were performed. Labs were evaluated for clinical significance at day 30, day 90, and day 180 visits.

Arm/Group Title	Apixaban		Warfarin
Arm/Group Description	Apixaban twice a day for 180 days w...		standard of care warfarin starting ...
Arm/Group Description	Apixaban twice a day for 180 days with drug initiation day 0-3 (TIA), day 3-5(small stroke) or day 7- 9 (medium stroke) respectively Apixaban		standard of care warfarin starting at day 7±5 (TIA) or day 14 ±5 (small to medium ischemic stroke). Warfarin
All-Cause Mortality
	Apixaban		Warfarin
	Affected / at Risk (%)		Affected / at Risk (%)
Total	2/41 (4.88%)		4/47 (8.51%)
Serious Adverse Events Serious Adverse Events
	Apixaban		Warfarin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/41 (26.83%)		14/47 (29.79%)
Blood and lymphatic system disorders
Symptomatic Anemia ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Cardiac disorders
Third Degree AV Block ^*	0/41 (0.00%)	0	2/47 (4.26%)	2
Worsening Congestive Heart Failure ^†	2/41 (4.88%)	2	0/47 (0.00%)	0
Worsening Atrial Fibrillation ^†	1/41 (2.44%)	1	2/47 (4.26%)	2
Symptomatic Hypotension ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Endocrine disorders
Pancreatic Cancer ^*	1/41 (2.44%)	1	0/47 (0.00%)	0
Gastrointestinal disorders
GI Bleed ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Small Bowel Obstruction ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Pancolitis ^†	0/41 (0.00%)	0	2/47 (4.26%)	2
General disorders
Fatal Stroke ^*	1/41 (2.44%)	1	3/47 (6.38%)	3
Symptomatic PH1 Hemorrhagic Transformation ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
TIA ^†	1/41 (2.44%)	1	2/47 (4.26%)	2
Acute Encephalopathy ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Recurrent Stroke ^†	5/41 (12.20%)	5	7/47 (14.89%)	7
Altered Mental Status ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Metabolic Encephalopathy ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Shortness of Breath ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Musculoskeletal and connective tissue disorders
Left Hip Fracture ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Rhabdomyolysis ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Second Digit Right Foot Amputation ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Back Fracture ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Worsening Back Pain ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Bilateral Leg Weakness / Trouble with Ambulation ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Right Hip Pain ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Ostectomy Left Foot ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Reproductive system and breast disorders
Ovarian Cyst ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
† Indicates events were collected by systematic assessment * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Apixaban		Warfarin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	36/41 (87.80%)		41/47 (87.23%)
Blood and lymphatic system disorders
Leukocytosis ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Cardiac disorders
Fatigue ^†	5/41 (12.20%)	5	5/47 (10.64%)	5
Dizziness ^†	2/41 (4.88%)	2	9/47 (19.15%)	10
Shortness of Breath ^†	2/41 (4.88%)	2	4/47 (8.51%)	4
Sinus Bradycardia ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Bilateral Lower Extremity Edema ^†	10/41 (24.39%)	11	3/47 (6.38%)	4
Hypertension ^†	1/41 (2.44%)	1	1/47 (2.13%)	1
Palpitations ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Blood Clot in Descending Aorta ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Pleuritic Chest Pain ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Chest Pain or Tightness ^†	6/41 (14.63%)	6	3/47 (6.38%)	4
Intermittent Cardiac Pauses ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Supratherapeutic INR ^†	0/41 (0.00%)	0	9/47 (19.15%)	29
Hypotension ^†	0/41 (0.00%)	0	2/47 (4.26%)	2
Bradycardia ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Orthostatic Loss of Consciousness ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Nonsustained Ventricular Tachycardia ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Supraventricular Tachycardia ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Pacemaker Implant for Arrhythmia ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Tachycardia ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Thrombus in Appendage ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Fluid Overload ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Heart Failure with Preserved Ejection Fraction ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Eye disorders
Left Eye Subconjunctival Hemorrhage ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Diploplia ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Gastrointestinal disorders
Vomiting ^†	3/41 (7.32%)	3	5/47 (10.64%)	6
Diarrhea ^†	2/41 (4.88%)	2	2/47 (4.26%)	2
Constipation ^†	1/41 (2.44%)	1	1/47 (2.13%)	1
Decreased Appetite ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Nausea ^†	2/41 (4.88%)	2	1/47 (2.13%)	1
Gastrointestinal Upset ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Esophagitis ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Gastrointestinal Bleed ^†	1/41 (2.44%)	2	0/47 (0.00%)	0
Acute Gastric Ulcer with Hemorrhage ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Abdominal Distention ^†	0/41 (0.00%)	0	1/47 (2.13%)	2
Viral Illness ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Gastritis ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
General disorders
Intermittent Headaches ^†	5/41 (12.20%)	5	5/47 (10.64%)	5
Asymptomatic Bleed ^†	5/41 (12.20%)	5	5/47 (10.64%)	5
Fever ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Difficulty Finding Words ^†	2/41 (4.88%)	2	0/47 (0.00%)	0
Intermittent Cognitive Impairment ^†	3/41 (7.32%)	3	2/47 (4.26%)	2
Cough ^†	2/41 (4.88%)	2	2/47 (4.26%)	3
Dry Mouth ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Altered Sense of Taste ^†	1/41 (2.44%)	1	1/47 (2.13%)	1
Cold Symptoms ^†	1/41 (2.44%)	1	2/47 (4.26%)	2
Sore Throat ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Worsening Hearing Loss ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Ataxia ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Right or Left Sided Weakness ^†	2/41 (4.88%)	2	1/47 (2.13%)	1
Shakiness ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Intermittent Lightheadedness ^†	2/41 (4.88%)	2	1/47 (2.13%)	1
Bronchitis ^†	3/41 (7.32%)	3	1/47 (2.13%)	1
Generalized Weakness ^†	1/41 (2.44%)	1	1/47 (2.13%)	1
Hemoptysis ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Hyponatremia ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Hypokalemia ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Hyperkalemia ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Left Lower Facial Numbness ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Parathesia ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Vertigo ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Sinus Infection ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Diaphoretic ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Responsive Only to Painful Stimuli ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Slurred Speech ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Blood in Sputum ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Motor Vehicle Accident with Injury ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
White Tongue ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Generalized Body Numbness ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Syncopal Episode ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Dehydration ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Hepatobiliary disorders
Abnormal Liver Tests ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Total Bilirubin Elevated ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Infections and infestations
Staph Infection Right Foot ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Ear and Nose Infection ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Bladder Infection ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Musculoskeletal and connective tissue disorders
Back Pain ^†	1/41 (2.44%)	1	3/47 (6.38%)	3
Intermittent Leg Cramping ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Body / Muscle Aches ^†	1/41 (2.44%)	1	3/47 (6.38%)	3
Back Pain with Ambulation ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Right Hip Pain ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Left Calf Sore ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Lower Back Pain ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Gout Right Foot ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Fall without Injury ^†	7/41 (17.07%)	9	3/47 (6.38%)	3
Left Foot Pain ^†	2/41 (4.88%)	2	1/47 (2.13%)	1
Unsteady Gait ^†	2/41 (4.88%)	2	0/47 (0.00%)	0
Intermittent Left Leg Pain ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Left Ankle Swelling ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Right Ankle Pain ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Right Foot Droop ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Sensory Peripheral Neuropathy ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Fall with Injury ^†	4/41 (9.76%)	4	2/47 (4.26%)	2
Facial and Neck Swelling ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Bilateral Lower Extremity Pain ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Muscle Spasticity ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Upper Extremity Stiffness ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Left Lower Extremity Edema ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Left Middle Finger Pain ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Minor Head Injury ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Right Great Toenail Removal Status Post Toe Injury ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Left Hamstring Injury ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Right Flank Pain ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small Benign Cysts, Right Hepatic Lobe ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Midpelvic Mass ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Renal and urinary disorders
Urinary Tract Infection ^†	6/41 (14.63%)	6	3/47 (6.38%)	3
Acute Kidney Injury ^†	1/41 (2.44%)	1	1/47 (2.13%)	1
Erectile Dysfunction ^†	1/41 (2.44%)	1	1/47 (2.13%)	1
Vaginal Bleeding ^†	2/41 (4.88%)	3	0/47 (0.00%)	0
Acute Renal Failure ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Hematuria ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Blood in Semen ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection ^†	2/41 (4.88%)	2	0/47 (0.00%)	0
Pneumonia ^†	1/41 (2.44%)	1	2/47 (4.26%)	2
Pulmonary Edema ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Bibasilar Rales ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Chronic Obstructive Pulmonary Disease Exacerbation ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Coarse Breath Sounds ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Wheezing ^†	1/41 (2.44%)	1	2/47 (4.26%)	2
Skin and subcutaneous tissue disorders
Left Foot Cellulitis ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Bruising ^†	1/41 (2.44%)	2	8/47 (17.02%)	12
Abrasions ^†	1/41 (2.44%)	1	6/47 (12.77%)	8
Right Chest Basal Cell Removal ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Upper Left Back Basal Cell Removal ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Right Temporal Laceration ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Scalp Hematoma ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Actinic Keratosis Left Forearm ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Squamous Cell Carcinoma ^†	1/41 (2.44%)	1	0/47 (0.00%)	0
Skin Peeling ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Skin Lesion to Nose ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Right Lower Extremity Blister ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
Bilateral Lower Extremity Dermatitis ^†	0/41 (0.00%)	0	1/47 (2.13%)	1
† Indicates events were collected by systematic assessment

Limitations and 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.

Results Point of Contact

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Name/Title:	David Rose, MD
Organization:	University of South Florida
Phone:	813-259-8577
EMail:	drose1@usf.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Labovitz AJ, Rose DZ, Fradley MG, Meriwether JN, Renati S, Martin R, Kasprowicz T, Murtagh R, Kip K, Beckie TM, Stoddard M, Bozeman AC, McTigue T, Kirby B, Tran N, Burgin WS; AREST Investigators. Early Apixaban Use Following Stroke in Patients With Atrial Fibrillation: Results of the AREST Trial. Stroke. 2021 Apr;52(4):1164-1171. doi: 10.1161/STROKEAHA.120.030042. Epub 2021 Feb 25.

Rose DZ, Meriwether JN, Fradley MG, Renati S, Martin RC, Kasprowicz T, Patel A, Mokin M, Murtagh R, Kip K, Bozeman AC, McTigue T, Hilker N, Kirby B, Wick N, Tran N, Burgin WS, Labovitz AJ. Protocol for AREST: Apixaban for Early Prevention of Recurrent Embolic Stroke and Hemorrhagic Transformation-A Randomized Controlled Trial of Early Anticoagulation After Acute Ischemic Stroke in Atrial Fibrillation. Front Neurol. 2019 Sep 20;10:975. doi: 10.3389/fneur.2019.00975. eCollection 2019.

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Responsible Party:	University of South Florida
ClinicalTrials.gov Identifier:	NCT02283294
Other Study ID Numbers:	PRO00019754
First Submitted:	October 29, 2014
First Posted:	November 5, 2014
Results First Submitted:	July 7, 2021
Results First Posted:	November 30, 2021
Last Update Posted:	November 30, 2021

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