Trial Outcomes & Findings for Thromboprophylaxis With Rivaroxaban In Patients With Malignancy and Central Venous Lines (NCT NCT03506815)
NCT ID: NCT03506815
Last Updated: 2024-07-05
Results Overview
A convenience sample size of 100 patients was chosen to allow reporting of the average monthly recruitment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
105 participants
Primary outcome timeframe
12 months
Results posted on
2024-07-05
Participant Flow
Participant milestones
| Measure |
Rivaroxaban Thromboprophylaxis
Rivaroxaban 10 mg po daily for 90 days(+/- 3 days). After the Day - 90 follow up, the study treatment will be discontinued and subsequent treatment will be at the discretion of the attending physician.
Rivaroxaban 10 MG: Rivaroxaban 10mg po daily x 90 (+/- 3 days)
|
Standard of Care
No rivaroxaban prophylaxis. Management will be at the discretion of the attending physician.
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
53
|
|
Overall Study
COMPLETED
|
37
|
53
|
|
Overall Study
NOT COMPLETED
|
15
|
0
|
Reasons for withdrawal
| Measure |
Rivaroxaban Thromboprophylaxis
Rivaroxaban 10 mg po daily for 90 days(+/- 3 days). After the Day - 90 follow up, the study treatment will be discontinued and subsequent treatment will be at the discretion of the attending physician.
Rivaroxaban 10 MG: Rivaroxaban 10mg po daily x 90 (+/- 3 days)
|
Standard of Care
No rivaroxaban prophylaxis. Management will be at the discretion of the attending physician.
|
|---|---|---|
|
Overall Study
Adverse Event
|
8
|
0
|
|
Overall Study
End of chemotherapy removal of peripherally inserted central venous catheter
|
5
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Elective Surgery
|
1
|
0
|
Baseline Characteristics
Thromboprophylaxis With Rivaroxaban In Patients With Malignancy and Central Venous Lines
Baseline characteristics by cohort
| Measure |
Rivaroxaban Thromboprophylaxis
n=52 Participants
Rivaroxaban 10 mg po daily for 90 days(+/- 3 days). After the Day - 90 follow up, the study treatment will be discontinued and subsequent treatment will be at the discretion of the attending physician.
Rivaroxaban 10 MG: Rivaroxaban 10mg po daily x 90 (+/- 3 days)
|
Standard of Care
n=53 Participants
No rivaroxaban prophylaxis. Management will be at the discretion of the attending physician.
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
61.6 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
60.8 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
50 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Cancer type
Breast
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Cancer type
Colorectal
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Cancer type
Stomach
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Cancer type
Gynecological
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Cancer type
Pancreas
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Cancer type
Other
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Central Venous Catheter Type
PICC
|
40 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Central Venous Catheter Type
Port-a-Cath
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Metastatic disease
|
14 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Total number of participants enrolled per site over a 12 month recruitment period.
A convenience sample size of 100 patients was chosen to allow reporting of the average monthly recruitment.
Outcome measures
| Measure |
Site 1
n=90 Participants
Ottawa Hospital
|
Site 2
n=15 Participants
Juravinski Hospital
|
|---|---|---|
|
Primary Feasibility Outcome - Number of Participants Recruited Per Month
|
7.5 Average enrolment rate/month/site
|
2.0 Average enrolment rate/month/site
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Data not collected for participants in the "Standard of Care" arm since they did not receive study medication and management was left to the discretion of the attending physician.
Good adherence defined as 80% or greater study medication taken in patients randomized to receive Rivaroxaban thromboprophylaxis.
Outcome measures
| Measure |
Site 1
n=52 Participants
Ottawa Hospital
|
Site 2
Juravinski Hospital
|
|---|---|---|
|
Secondary Feasibility Outcomes - Percentage of Participants With Good Adherence to Therapy
|
96.7 percentage of participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 daysThrombotic complication was defined as a combination of major venous thromboembolism (VTE); any symptomatic or incidentally detected proximal deep vein thrombosis (DVT) of the lower or upper limbs, any nonfatal symptomatic or incidental pulmonary embolism (PE), and pulmonary embolism-related death) and any other deep (ie, distal, splanchnic, or cerebral) or superficial venous thrombosis.
Outcome measures
| Measure |
Site 1
n=52 Participants
Ottawa Hospital
|
Site 2
n=53 Participants
Juravinski Hospital
|
|---|---|---|
|
Number of Participants With Thrombotic Complication
Major VTE
|
2 Participants
|
3 Participants
|
|
Number of Participants With Thrombotic Complication
Major VTE - Upper extremity
|
2 Participants
|
2 Participants
|
|
Number of Participants With Thrombotic Complication
Major VTE - PE
|
0 Participants
|
1 Participants
|
|
Number of Participants With Thrombotic Complication
Other thrombotic event - splanchnic vein thrombosis
|
1 Participants
|
1 Participants
|
|
Number of Participants With Thrombotic Complication
Other thrombotic event - superficial vein thrombosis
|
0 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 daysCentral venous catheter (CVC) occlusion was defined as an obstruction of the CVC lumen that prevents or limits the ability to flush, withdraw blood, and/or administer solutions or medications
Outcome measures
| Measure |
Site 1
n=52 Participants
Ottawa Hospital
|
Site 2
n=53 Participants
Juravinski Hospital
|
|---|---|---|
|
Number of Participants With CVC-Related Complication
CVC-associated infection
|
0 Participants
|
2 Participants
|
|
Number of Participants With CVC-Related Complication
CVC migration
|
0 Participants
|
1 Participants
|
|
Number of Participants With CVC-Related Complication
CVC positional occlusion
|
0 Participants
|
1 Participants
|
|
Number of Participants With CVC-Related Complication
CVC occlusion
|
0 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 daysDefined by the International Society on Thrombosis and Haemostasis (ISTH) as overt bleeding associated with a decrease in the hemoglobin level of ≥2 g/dL, which led to transfusion of two or more units of packed red blood cells, occurred in a critical site, or contributed to death.
Outcome measures
| Measure |
Site 1
n=52 Participants
Ottawa Hospital
|
Site 2
n=53 Participants
Juravinski Hospital
|
|---|---|---|
|
Number of Participants With Major Bleeding
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 daysClinically relevant non-major bleeding, as per the standardized definition by the ISTH, is any signs or symptoms of hemorrhage not meeting criteria for major bleeding but associated with medical intervention, unscheduled in-person contact with a healthcare professional or need for hospitalization or increased level of care.
Outcome measures
| Measure |
Site 1
n=52 Participants
Ottawa Hospital
|
Site 2
n=53 Participants
Juravinski Hospital
|
|---|---|---|
|
Number of Participants With Clinically Relevant Non-Major Bleed
|
2 Participants
|
2 Participants
|
Adverse Events
Rivaroxaban Thromboprophylaxis
Serious events: 11 serious events
Other events: 16 other events
Deaths: 0 deaths
Standard of Care
Serious events: 10 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rivaroxaban Thromboprophylaxis
n=52 participants at risk
Rivaroxaban 10 mg po daily for 90 days(+/- 3 days). After the Day - 90 follow up, the study treatment will be discontinued and subsequent treatment will be at the discretion of the attending physician.
Rivaroxaban 10 MG: Rivaroxaban 10mg po daily x 90 (+/- 3 days)
|
Standard of Care
n=53 participants at risk
No rivaroxaban prophylaxis. Management will be at the discretion of the attending physician.
|
|---|---|---|
|
Gastrointestinal disorders
Major Bleed
|
1.9%
1/52 • Number of events 1 • 3 months
|
0.00%
0/53 • 3 months
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
100.0%
1/1 • Number of events 1 • 3 months
|
0.00%
0/53 • 3 months
|
|
Immune system disorders
Fever
|
5.8%
3/52 • Number of events 3 • 3 months
|
0.00%
0/53 • 3 months
|
|
Gastrointestinal disorders
Small Bowel Obstruction
|
5.8%
3/52 • Number of events 3 • 3 months
|
0.00%
0/53 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
1.9%
1/52 • Number of events 1 • 3 months
|
1.9%
1/53 • Number of events 1 • 3 months
|
|
General disorders
Chest Pain
|
0.00%
0/52 • 3 months
|
1.9%
1/53 • Number of events 1 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Decreased O2
|
1.9%
1/52 • Number of events 1 • 3 months
|
0.00%
0/53 • 3 months
|
|
Skin and subcutaneous tissue disorders
Ulcer
|
0.00%
0/52 • 3 months
|
1.9%
1/53 • Number of events 1 • 3 months
|
|
Infections and infestations
E-Coli, Urinary Tract Infection
|
0.00%
0/52 • 3 months
|
1.9%
1/53 • Number of events 1 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pnemonia
|
1.9%
1/52 • Number of events 1 • 3 months
|
3.8%
2/53 • Number of events 2 • 3 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/52 • 3 months
|
1.9%
1/53 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
Neutropenia Enterocolitis
|
0.00%
0/52 • 3 months
|
1.9%
1/53 • Number of events 1 • 3 months
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/52 • 3 months
|
1.9%
1/53 • Number of events 1 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory infection
|
0.00%
0/52 • 3 months
|
1.9%
1/53 • Number of events 1 • 3 months
|
Other adverse events
| Measure |
Rivaroxaban Thromboprophylaxis
n=52 participants at risk
Rivaroxaban 10 mg po daily for 90 days(+/- 3 days). After the Day - 90 follow up, the study treatment will be discontinued and subsequent treatment will be at the discretion of the attending physician.
Rivaroxaban 10 MG: Rivaroxaban 10mg po daily x 90 (+/- 3 days)
|
Standard of Care
n=53 participants at risk
No rivaroxaban prophylaxis. Management will be at the discretion of the attending physician.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.9%
1/52 • Number of events 1 • 3 months
|
1.9%
1/53 • Number of events 1 • 3 months
|
|
General disorders
Common Cold
|
1.9%
1/52 • Number of events 1 • 3 months
|
0.00%
0/53 • 3 months
|
|
Injury, poisoning and procedural complications
Chemotherapy Infusion Reaction
|
1.9%
1/52 • Number of events 1 • 3 months
|
1.9%
1/53 • Number of events 1 • 3 months
|
|
General disorders
Chest pain
|
1.9%
1/52 • Number of events 1 • 3 months
|
1.9%
1/53 • Number of events 1 • 3 months
|
|
General disorders
Dizziness
|
0.00%
0/52 • 3 months
|
1.9%
1/53 • Number of events 1 • 3 months
|
|
General disorders
Fever
|
3.8%
2/52 • Number of events 2 • 3 months
|
1.9%
1/53 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
GERD
|
0.00%
0/52 • 3 months
|
1.9%
1/53 • Number of events 1 • 3 months
|
|
Skin and subcutaneous tissue disorders
Herpes
|
0.00%
0/52 • 3 months
|
1.9%
1/53 • Number of events 1 • 3 months
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/52 • 3 months
|
1.9%
1/53 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
Indigestion
|
3.8%
2/52 • Number of events 2 • 3 months
|
0.00%
0/53 • 3 months
|
|
Infections and infestations
Yeast Infection
|
0.00%
0/52 • 3 months
|
1.9%
1/53 • Number of events 1 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Lower back pain
|
1.9%
1/52 • Number of events 1 • 3 months
|
0.00%
0/53 • 3 months
|
|
Nervous system disorders
Migraine
|
1.9%
1/52 • Number of events 1 • 3 months
|
0.00%
0/53 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/52 • 3 months
|
1.9%
1/53 • Number of events 1 • 3 months
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/52 • 3 months
|
1.9%
1/53 • Number of events 1 • 3 months
|
|
Injury, poisoning and procedural complications
Radiation toxicity
|
1.9%
1/52 • Number of events 1 • 3 months
|
0.00%
0/53 • 3 months
|
|
Injury, poisoning and procedural complications
Prolongation post chemo pain
|
1.9%
1/52 • Number of events 1 • 3 months
|
0.00%
0/53 • 3 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.8%
2/52 • Number of events 2 • 3 months
|
1.9%
1/53 • Number of events 1 • 3 months
|
|
Blood and lymphatic system disorders
Symptomatic Anemia
|
0.00%
0/52 • 3 months
|
3.8%
2/53 • Number of events 2 • 3 months
|
|
General disorders
Syncope
|
0.00%
0/52 • 3 months
|
1.9%
1/53 • Number of events 1 • 3 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.6%
5/52 • Number of events 7 • 3 months
|
3.8%
2/53 • Number of events 3 • 3 months
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/52 • 3 months
|
1.9%
1/53 • Number of events 1 • 3 months
|
|
Infections and infestations
Urinary Tract Infection
|
1.9%
1/52 • Number of events 1 • 3 months
|
1.9%
1/53 • Number of events 1 • 3 months
|
|
Infections and infestations
Urosepsis
|
1.9%
1/52 • Number of events 1 • 3 months
|
0.00%
0/53 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place