AREST: Apixaban for Early Prevention of Recurrent Embolic Stroke and Hemorrhagic Transformation
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate if Apixaban will decrease the complication of having another stroke for people who have atrial fibrillation if initiated earlier than standard of care.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
This is an Open label, randomized, active control, parallel-group pilot trial to examine the effect of initiation of APIXABAN at days 0-3 (TIA), days 3-5 (small stroke) and days 7-9 (medium stroke) to decrease fatal and/or recurrent stroke/TIA in 120 subjects who have suffered a recent( 0 to 48 hours from symptoms) TIA, or small to medium ischemic stroke compared to standard of care warfarin treatment regimen. Subjects will be randomly assigned in a 1:1 ratio to one of two treatment arms (apixaban or warfarin). Subjects will be followed for a total of 180 days during from screening through monthly follow-up visits.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Apixaban 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 |
Drug: Apixaban
|
| Active Comparator: Warfarin standard of care warfarin starting at day 7±5 (TIA) or day 14 ±5 (small to medium ischemic stroke). |
Drug: Warfarin
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With a Composite Endpoint of Fatal Stroke, Recurrent Ischemic Stroke, or TIA [180 days]
Secondary Outcome Measures
- Number of Participants With an Intracranial Hemorrhage Assessed by MRI/CT [180 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Signed Written Informed Consent
-
Males and Females over 18 years of age.
-
History of Nonvalvular Atrial Fibrillation (NVAF) by documentation in the medical history or newly diagnosed nonvalvular Atrial Fibrillation at time of study randomization by ECG, device or telemetry .
-
Diagnosis of TIA or small or medium ischemic stroke 0 to 48 hours from signs or symptoms.
-
Women of child-bearing potential must use a reliable method of contraception and must provide a negative pregnancy test at entry into the study and within 24 hours of study treatment initiation.
-
WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug Apixaban plus 5 half-lives (approximately 3 days) plus 30 days (duration of ovulatory cycle) 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 the duration of treatment with Apixaban plus 5 half-lives (approximately 3 days) plus 90 days (duration of sperm turnover) 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 they must still undergo pregnancy testing as described in this section.
Investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy Investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective methods of contraception. Highly effective methods of contraception have a failure rate of < 1% when used consistently and correctly.
At a minimum, subjects must agree to the use of one method of highly effective contraception as listed below:
HIGHLY EFFECTIVE METHODS OF CONTRACEPTION
-
Male condoms with spermicide
-
Hormonal methods of contraception including combined oral contraceptive pills, vaginal ring, injectables, implants and intrauterine devices (IUDs) such as Mirena by WOCBP subject or male subject's WOCBP partner. Female partners of male subjects participating in the study may use hormone based contraceptives as one of the acceptable methods of contraception since they will not be receiving study drug
-
IUDs, such as ParaGard™
-
Tubal ligation
-
Vasectomy.
-
Complete Abstinence
Exclusion Criteria:
-
Hemorrhagic stroke
-
Large ischemic stroke
-
History of major bleeding within the last 6 months from time of subject enrollment (e.g. GI bleed).
-
History of intracranial bleed
- Traumatic intracranial bleed within one year of randomization. (Traumatic ICH greater than one year of randomization is not an exclusion).
-
Current or history of bleeding disorders (e.g. blood dycrasias)
-
Blood Pressure of 180/100 mmHg on hypertensive therapy day of randomization per PI discretion 20.
-
Current illicit drug use and/or chronic alcohol use per PI discretion.
-
Severe liver disease (AST/ALT 2x upper limit).
-
Patients with kidney disease meeting criteria to take 2.5 mg twice daily who are taking strong dual inhibitors of CYP3A4 and P-glycoprotein (e.g. ketoconazole, itraconazole, ritonavir, clarithromycin) .
-
Any other suspected etiology for stroke (e.g. ipsilateral carotid disease).
-
Greater than 3 Cerebral Micro-bleeds (CMB) on gradient recovery echo (GRE) or evidence of intracranial hemorrhage on CT at time of randomization. (SWI sequencing may be used if GRE sequencing is not obtainable)
-
Therapeutically anti-coagulated at time of admission (INR at admission greater than 2.0 on warfarin or took two consecutive doses of NOAC).
-
Absolute indication for use of warfarin only.( e.g. Mechanical Valve)
-
Absolute indication for anticoagulation prior to randomization window. (e.g. DVT)
-
Hemoglobin less than 9 gm/dl and/or platelet count less than 100 K/uL.
-
Requires dual antiplatelet therapy.
-
Daily use of NSAIDS
-
Pregnancy or lactation.
-
Any use of an investigational product within the past 30 days.
-
Prisoners or subjects who are involuntarily incarcerated.
-
Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
-
Concurrent participation in another clinical study where use of an investigational product is used
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center | Torrance | California | United States | 90502 |
| 2 | Bayfront Health St Petersburg | Saint Petersburg | Florida | United States | 33701 |
| 3 | Tampa General Hospital | Tampa | Florida | United States | 33602 |
| 4 | University of South Florida | Tampa | Florida | United States | 33602 |
| 5 | University of Louisville | Louisville | Kentucky | United States | 40202 |
Sponsors and Collaborators
- University of South Florida
- Bristol-Myers Squibb
Investigators
- Principal Investigator: Michael Fradley, M.D., University of South Florida, Department of Cardiovascular Sciences
Study Documents (Full-Text)
More Information
Publications
None provided.- PRO00019754
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 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 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 | 41 | 47 |
| Received Allocated Treatment Intervention | 38 | 31 |
| COMPLETED | 38 | 39 |
| NOT COMPLETED | 3 | 8 |
Baseline Characteristics
| Arm/Group Title | Apixaban | Warfarin | Total |
|---|---|---|---|
| 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 Participants | 41 | 47 | 88 |
| Age (Count of Participants) | |||
| <=18 years |
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 (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
72.6
(14.9)
|
74.3
(10.5)
|
73.5
(12.7)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
26
63.4%
|
23
48.9%
|
49
55.7%
|
| Male |
15
36.6%
|
24
51.1%
|
39
44.3%
|
| Race/Ethnicity, Customized (Count of 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%
|
| Other |
0
0%
|
1
2.1%
|
1
1.1%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
41
100%
|
47
100%
|
88
100%
|
| Hypertension (Count of Participants) | |||
| Count of Participants [Participants] |
38
92.7%
|
46
97.9%
|
84
95.5%
|
| Hyperlipidemia (Count of Participants) | |||
| Count of Participants [Participants] |
24
58.5%
|
34
72.3%
|
58
65.9%
|
| Coronary artery disease (CAD) (Count of Participants) | |||
| Count of Participants [Participants] |
13
31.7%
|
18
38.3%
|
31
35.2%
|
| Diabetes Mellitus (Count of Participants) | |||
| Count of Participants [Participants] |
10
24.4%
|
22
46.8%
|
32
36.4%
|
| Peripheral Artery Disease (Count of Participants) | |||
| Count of Participants [Participants] |
4
9.8%
|
9
19.1%
|
13
14.8%
|
| Prior Stroke (Count of Participants) | |||
| Count of Participants [Participants] |
9
22%
|
10
21.3%
|
19
21.6%
|
| Prosthetic Heart Valve / Valve Replacement (Count of Participants) | |||
| Count of Participants [Participants] |
1
2.4%
|
4
8.5%
|
5
5.7%
|
| Thyroid Disease (Count of Participants) | |||
| Count of Participants [Participants] |
9
22%
|
13
27.7%
|
22
25%
|
| Obstructive Sleep Apnea (Count of Participants) | |||
| Count of Participants [Participants] |
5
12.2%
|
7
14.9%
|
12
13.6%
|
| Congestive Heart Failure Symptoms (Count of Participants) | |||
| Count of Participants [Participants] |
3
7.3%
|
9
19.1%
|
12
13.6%
|
| Past Medical History Left Ventricular Ejection Fraction < 40% (Count of Participants) | |||
| Count of Participants [Participants] |
6
14.6%
|
13
27.7%
|
19
21.6%
|
| Chronic Kidney Disease Stage 3 (Count of Participants) | |||
| Count of Participants [Participants] |
7
17.1%
|
15
31.9%
|
22
25%
|
| Chronic Kidney Disease Stage 4 (Count of Participants) | |||
| Count of Participants [Participants] |
1
2.4%
|
2
4.3%
|
3
3.4%
|
| Chronic Kidney Disease Stage 5 (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
| Transient Ischemic Attack (Count of Participants) | |||
| Count of Participants [Participants] |
4
9.8%
|
3
6.4%
|
7
8%
|
| Thromboembolism History (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
3
6.4%
|
3
3.4%
|
| New Onset Atrial Fibrillation (Count of Participants) | |||
| Count of Participants [Participants] |
14
34.1%
|
14
29.8%
|
28
31.8%
|
| Prior Use of Anticoagulation within last 3 months (Count of Participants) | |||
| Count of Participants [Participants] |
3
7.3%
|
11
23.4%
|
14
15.9%
|
| Former Tobacco Use History (Count of Participants) | |||
| Count of Participants [Participants] |
10
24.4%
|
13
27.7%
|
23
26.1%
|
| Former Alcohol Use History (Count of Participants) | |||
| Count of Participants [Participants] |
1
2.4%
|
2
4.3%
|
3
3.4%
|
| Former Illegal Drug Use History (Count of Participants) | |||
| Count of Participants [Participants] |
1
2.4%
|
1
2.1%
|
2
2.3%
|
| Height (m) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [m] |
1.67
(0.11)
|
1.712
(0.14)
|
1.69
(0.13)
|
| Weight (kg) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kg] |
82.10
(24.09)
|
88.08
(24.73)
|
85.29
(24.48)
|
| Body Mass Index (kg/m^2) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kg/m^2] |
29.15
(6.68)
|
30.05
(7.60)
|
29.63
(7.16)
|
| Body Surface Area (m^2) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [m^2] |
1.90
(0.28)
|
1.99
(0.31)
|
1.95
(0.30)
|
| Heart Rate (bpm) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [bpm] |
76.56
(14.46)
|
76.62
(16.61)
|
76.60
(15.56)
|
| Systolic Blood Pressure (mmHg) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mmHg] |
130.85
(18.64)
|
134.53
(20.13)
|
132.82
(19.43)
|
| Current Tobacco Use (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
4
8.5%
|
4
4.5%
|
| Occasional Tobacco Use (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
| Current Alcohol Use (Count of Participants) | |||
| Count of Participants [Participants] |
6
14.6%
|
6
12.8%
|
12
13.6%
|
| Occasional Alcohol Use (Count of Participants) | |||
| Count of Participants [Participants] |
9
22%
|
8
17%
|
17
19.3%
|
| Diastolic Blood Pressure (mmHg) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mmHg] |
74.07
(17.76)
|
70.26
(19.50)
|
72.03
(18.70)
|
Outcome Measures
| Title | Number of Participants With a Composite Endpoint of Fatal Stroke, Recurrent Ischemic Stroke, or TIA |
|---|---|
| Description | |
| 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 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 |
| Measure Participants | 41 | 47 |
| Count of Participants [Participants] |
7
17.1%
|
12
25.5%
|
| Title | Number of Participants With an Intracranial Hemorrhage Assessed by MRI/CT |
|---|---|
| Description | |
| 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 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 |
| Measure Participants | 41 | 47 |
| Count of Participants [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 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 (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/41 (4.9%) | 4/47 (8.5%) | ||
Serious Adverse Events |
||||
| Apixaban | Warfarin | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 11/41 (26.8%) | 14/47 (29.8%) | ||
| Blood and lymphatic system disorders | ||||
| Symptomatic Anemia | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Cardiac disorders | ||||
| Third Degree AV Block | 0/41 (0%) | 0 | 2/47 (4.3%) | 2 |
| Worsening Congestive Heart Failure | 2/41 (4.9%) | 2 | 0/47 (0%) | 0 |
| Worsening Atrial Fibrillation | 1/41 (2.4%) | 1 | 2/47 (4.3%) | 2 |
| Symptomatic Hypotension | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Endocrine disorders | ||||
| Pancreatic Cancer | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Gastrointestinal disorders | ||||
| GI Bleed | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Small Bowel Obstruction | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Pancolitis | 0/41 (0%) | 0 | 2/47 (4.3%) | 2 |
| General disorders | ||||
| Fatal Stroke | 1/41 (2.4%) | 1 | 3/47 (6.4%) | 3 |
| Symptomatic PH1 Hemorrhagic Transformation | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| TIA | 1/41 (2.4%) | 1 | 2/47 (4.3%) | 2 |
| Acute Encephalopathy | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Recurrent Stroke | 5/41 (12.2%) | 5 | 7/47 (14.9%) | 7 |
| Altered Mental Status | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Metabolic Encephalopathy | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Shortness of Breath | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Left Hip Fracture | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Rhabdomyolysis | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Second Digit Right Foot Amputation | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Back Fracture | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Worsening Back Pain | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Bilateral Leg Weakness / Trouble with Ambulation | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Right Hip Pain | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Ostectomy Left Foot | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Reproductive system and breast disorders | ||||
| Ovarian Cyst | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Apixaban | Warfarin | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 36/41 (87.8%) | 41/47 (87.2%) | ||
| Blood and lymphatic system disorders | ||||
| Leukocytosis | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Cardiac disorders | ||||
| Fatigue | 5/41 (12.2%) | 5 | 5/47 (10.6%) | 5 |
| Dizziness | 2/41 (4.9%) | 2 | 9/47 (19.1%) | 10 |
| Shortness of Breath | 2/41 (4.9%) | 2 | 4/47 (8.5%) | 4 |
| Sinus Bradycardia | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Bilateral Lower Extremity Edema | 10/41 (24.4%) | 11 | 3/47 (6.4%) | 4 |
| Hypertension | 1/41 (2.4%) | 1 | 1/47 (2.1%) | 1 |
| Palpitations | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Blood Clot in Descending Aorta | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Pleuritic Chest Pain | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Chest Pain or Tightness | 6/41 (14.6%) | 6 | 3/47 (6.4%) | 4 |
| Intermittent Cardiac Pauses | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Supratherapeutic INR | 0/41 (0%) | 0 | 9/47 (19.1%) | 29 |
| Hypotension | 0/41 (0%) | 0 | 2/47 (4.3%) | 2 |
| Bradycardia | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Orthostatic Loss of Consciousness | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Nonsustained Ventricular Tachycardia | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Supraventricular Tachycardia | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Pacemaker Implant for Arrhythmia | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Tachycardia | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Thrombus in Appendage | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Fluid Overload | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Heart Failure with Preserved Ejection Fraction | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Eye disorders | ||||
| Left Eye Subconjunctival Hemorrhage | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Diploplia | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Gastrointestinal disorders | ||||
| Vomiting | 3/41 (7.3%) | 3 | 5/47 (10.6%) | 6 |
| Diarrhea | 2/41 (4.9%) | 2 | 2/47 (4.3%) | 2 |
| Constipation | 1/41 (2.4%) | 1 | 1/47 (2.1%) | 1 |
| Decreased Appetite | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Nausea | 2/41 (4.9%) | 2 | 1/47 (2.1%) | 1 |
| Gastrointestinal Upset | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Esophagitis | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Gastrointestinal Bleed | 1/41 (2.4%) | 2 | 0/47 (0%) | 0 |
| Acute Gastric Ulcer with Hemorrhage | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Abdominal Distention | 0/41 (0%) | 0 | 1/47 (2.1%) | 2 |
| Viral Illness | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Gastritis | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| General disorders | ||||
| Intermittent Headaches | 5/41 (12.2%) | 5 | 5/47 (10.6%) | 5 |
| Asymptomatic Bleed | 5/41 (12.2%) | 5 | 5/47 (10.6%) | 5 |
| Fever | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Difficulty Finding Words | 2/41 (4.9%) | 2 | 0/47 (0%) | 0 |
| Intermittent Cognitive Impairment | 3/41 (7.3%) | 3 | 2/47 (4.3%) | 2 |
| Cough | 2/41 (4.9%) | 2 | 2/47 (4.3%) | 3 |
| Dry Mouth | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Altered Sense of Taste | 1/41 (2.4%) | 1 | 1/47 (2.1%) | 1 |
| Cold Symptoms | 1/41 (2.4%) | 1 | 2/47 (4.3%) | 2 |
| Sore Throat | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Worsening Hearing Loss | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Ataxia | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Right or Left Sided Weakness | 2/41 (4.9%) | 2 | 1/47 (2.1%) | 1 |
| Shakiness | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Intermittent Lightheadedness | 2/41 (4.9%) | 2 | 1/47 (2.1%) | 1 |
| Bronchitis | 3/41 (7.3%) | 3 | 1/47 (2.1%) | 1 |
| Generalized Weakness | 1/41 (2.4%) | 1 | 1/47 (2.1%) | 1 |
| Hemoptysis | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Hyponatremia | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Hypokalemia | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Hyperkalemia | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Left Lower Facial Numbness | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Parathesia | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Vertigo | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Sinus Infection | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Diaphoretic | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Responsive Only to Painful Stimuli | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Slurred Speech | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Blood in Sputum | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Motor Vehicle Accident with Injury | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| White Tongue | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Generalized Body Numbness | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Syncopal Episode | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Dehydration | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Hepatobiliary disorders | ||||
| Abnormal Liver Tests | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Infections and infestations | ||||
| Staph Infection Right Foot | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Ear and Nose Infection | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Bladder Infection | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Back Pain | 1/41 (2.4%) | 1 | 3/47 (6.4%) | 3 |
| Intermittent Leg Cramping | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Body / Muscle Aches | 1/41 (2.4%) | 1 | 3/47 (6.4%) | 3 |
| Back Pain with Ambulation | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Right Hip Pain | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Left Calf Sore | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Lower Back Pain | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Gout Right Foot | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Fall without Injury | 7/41 (17.1%) | 9 | 3/47 (6.4%) | 3 |
| Left Foot Pain | 2/41 (4.9%) | 2 | 1/47 (2.1%) | 1 |
| Unsteady Gait | 2/41 (4.9%) | 2 | 0/47 (0%) | 0 |
| Intermittent Left Leg Pain | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Left Ankle Swelling | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Right Ankle Pain | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Right Foot Droop | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Sensory Peripheral Neuropathy | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Fall with Injury | 4/41 (9.8%) | 4 | 2/47 (4.3%) | 2 |
| Facial and Neck Swelling | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Bilateral Lower Extremity Pain | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Muscle Spasticity | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Upper Extremity Stiffness | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Left Lower Extremity Edema | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Left Middle Finger Pain | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Minor Head Injury | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Right Great Toenail Removal Status Post Toe Injury | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Left Hamstring Injury | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Right Flank Pain | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Small Benign Cysts, Right Hepatic Lobe | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Midpelvic Mass | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Renal and urinary disorders | ||||
| Urinary Tract Infection | 6/41 (14.6%) | 6 | 3/47 (6.4%) | 3 |
| Acute Kidney Injury | 1/41 (2.4%) | 1 | 1/47 (2.1%) | 1 |
| Erectile Dysfunction | 1/41 (2.4%) | 1 | 1/47 (2.1%) | 1 |
| Vaginal Bleeding | 2/41 (4.9%) | 3 | 0/47 (0%) | 0 |
| Acute Renal Failure | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Hematuria | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Blood in Semen | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Upper Respiratory Infection | 2/41 (4.9%) | 2 | 0/47 (0%) | 0 |
| Pneumonia | 1/41 (2.4%) | 1 | 2/47 (4.3%) | 2 |
| Pulmonary Edema | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Bibasilar Rales | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Chronic Obstructive Pulmonary Disease Exacerbation | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Coarse Breath Sounds | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Wheezing | 1/41 (2.4%) | 1 | 2/47 (4.3%) | 2 |
| Skin and subcutaneous tissue disorders | ||||
| Left Foot Cellulitis | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Bruising | 1/41 (2.4%) | 2 | 8/47 (17%) | 12 |
| Abrasions | 1/41 (2.4%) | 1 | 6/47 (12.8%) | 8 |
| Right Chest Basal Cell Removal | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Upper Left Back Basal Cell Removal | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Right Temporal Laceration | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Scalp Hematoma | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Actinic Keratosis Left Forearm | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Squamous Cell Carcinoma | 1/41 (2.4%) | 1 | 0/47 (0%) | 0 |
| Skin Peeling | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Skin Lesion to Nose | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Right Lower Extremity Blister | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
| Bilateral Lower Extremity Dermatitis | 0/41 (0%) | 0 | 1/47 (2.1%) | 1 |
Limitations/Caveats
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
| Name/Title | David Rose, MD |
|---|---|
| Organization | University of South Florida |
| Phone | 813-259-8577 |
| drose1@usf.edu |
- PRO00019754