Trial Outcomes & Findings for Enoxaparin Versus Aspirin in Patients With Cancer and Stroke (NCT NCT01763606)
NCT ID: NCT01763606
Last Updated: 2020-08-14
Results Overview
Number of Participants with intracranial hemorrhage, symptomatic intracranial hemorrhage, major bleeding, and death
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
1 year
Results posted on
2020-08-14
Participant Flow
Participant milestones
| Measure |
Enoxaparin
Patients assigned to enoxaparin.
Enoxaparin: Patients will be receive 6 months of subcutaneous enoxaparin (1 mg/kg BID with a maximum starting dose of 100 mg BID. Patients who weigh more than 100 kg will start at a dose of 100 mg BID; their subsequent dosing will be guided by hematology and may change.
|
Aspirin
Patients assigned to Aspirin.
Aspirin: Patients will receive 6 months of oral aspirin (81 mg per day unless a higher dose is preferred by study physicians although the maximum acceptable dose will be 325 mg per day).
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Enoxaparin Versus Aspirin in Patients With Cancer and Stroke
Baseline characteristics by cohort
| Measure |
Enoxaparin
n=10 Participants
Patients assigned to enoxaparin.
Enoxaparin: Patients will be receive 6 months of subcutaneous enoxaparin (1 mg/kg BID with a maximum starting dose of 100 mg BID. Patients who weigh more than 100 kg will start at a dose of 100 mg BID; their subsequent dosing will be guided by hematology and may change.
|
Aspirin
n=10 Participants
Patients assigned to Aspirin.
Aspirin: Patients will receive 6 months of oral aspirin (81 mg per day unless a higher dose is preferred by study physicians although the maximum acceptable dose will be 325 mg per day).
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68 years
n=5 Participants
|
71 years
n=7 Participants
|
71 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearNumber of Participants with intracranial hemorrhage, symptomatic intracranial hemorrhage, major bleeding, and death
Outcome measures
| Measure |
Enoxaparin
n=10 Participants
Patients assigned to enoxaparin.
Enoxaparin: Patients will be receive 6 months of subcutaneous enoxaparin (1 mg/kg BID with a maximum starting dose of 100 mg BID. Patients who weigh more than 100 kg will start at a dose of 100 mg BID; their subsequent dosing will be guided by hematology and may change.
|
Aspirin
n=10 Participants
Patients assigned to Aspirin.
Aspirin: Patients will receive 6 months of oral aspirin (81 mg per day unless a higher dose is preferred by study physicians although the maximum acceptable dose will be 325 mg per day).
|
|---|---|---|
|
Safety Outcomes
Fatal Recurrent AIS
|
1 Participants
|
0 Participants
|
|
Safety Outcomes
Nonfatal gastrointestinal bleeding
|
0 Participants
|
3 Participants
|
|
Safety Outcomes
Nonfatal pulmonary hemorrhage
|
1 Participants
|
0 Participants
|
|
Safety Outcomes
No hemorrahage, major bleeding or death
|
8 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe primary feasibility outcome is patient enrollment defined as the number of patients who enroll in the study divided by the number of patients who were eligible to enroll.
Outcome measures
| Measure |
Enoxaparin
n=49 Participants
Patients assigned to enoxaparin.
Enoxaparin: Patients will be receive 6 months of subcutaneous enoxaparin (1 mg/kg BID with a maximum starting dose of 100 mg BID. Patients who weigh more than 100 kg will start at a dose of 100 mg BID; their subsequent dosing will be guided by hematology and may change.
|
Aspirin
Patients assigned to Aspirin.
Aspirin: Patients will receive 6 months of oral aspirin (81 mg per day unless a higher dose is preferred by study physicians although the maximum acceptable dose will be 325 mg per day).
|
|---|---|---|
|
Feasibility Outcomes
|
41 percentage of eligible pts enrolled
Interval 27.0 to 55.0
|
—
|
SECONDARY outcome
Timeframe: 6 monthsSecondary efficacy outcomes will be assessed for and will include recurrent ischemic stroke, all strokes (ischemic or hemorrhagic), transient ischemic attack, myocardial infarction, deep vein thrombosis, pulmonary embolism, and systemic arterial thrombosis. Functional outcomes will also be evaluated, including the modified Rankin Scale score, the National Institute of Health Stroke Scale, and the Karnofsky Performance Status Scale.
Outcome measures
| Measure |
Enoxaparin
n=10 Participants
Patients assigned to enoxaparin.
Enoxaparin: Patients will be receive 6 months of subcutaneous enoxaparin (1 mg/kg BID with a maximum starting dose of 100 mg BID. Patients who weigh more than 100 kg will start at a dose of 100 mg BID; their subsequent dosing will be guided by hematology and may change.
|
Aspirin
n=10 Participants
Patients assigned to Aspirin.
Aspirin: Patients will receive 6 months of oral aspirin (81 mg per day unless a higher dose is preferred by study physicians although the maximum acceptable dose will be 325 mg per day).
|
|---|---|---|
|
Number of Participants With or Without Recurrent Ischemic Stroke
Recurrent ischemic event
|
1 Participants
|
0 Participants
|
|
Number of Participants With or Without Recurrent Ischemic Stroke
No recurrent ischemic event
|
9 Participants
|
10 Participants
|
Adverse Events
Enoxaparin
Serious events: 5 serious events
Other events: 10 other events
Deaths: 6 deaths
Aspirin
Serious events: 6 serious events
Other events: 10 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Enoxaparin
n=10 participants at risk
Patients assigned to enoxaparin.
Enoxaparin: Patients will be receive 6 months of subcutaneous enoxaparin (1 mg/kg BID with a maximum starting dose of 100 mg BID. Patients who weigh more than 100 kg will start at a dose of 100 mg BID; their subsequent dosing will be guided by hematology and may change.
|
Aspirin
n=10 participants at risk
Patients assigned to Aspirin.
Aspirin: Patients will receive 6 months of oral aspirin (81 mg per day unless a higher dose is preferred by study physicians although the maximum acceptable dose will be 325 mg per day).
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • 1 year
|
0.00%
0/10 • 1 year
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
10.0%
1/10 • 1 year
|
0.00%
0/10 • 1 year
|
|
General disorders
Fever
|
10.0%
1/10 • 1 year
|
0.00%
0/10 • 1 year
|
|
Gastrointestinal disorders
Mucositis oral
|
10.0%
1/10 • 1 year
|
0.00%
0/10 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
10.0%
1/10 • 1 year
|
0.00%
0/10 • 1 year
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.0%
1/10 • 1 year
|
0.00%
0/10 • 1 year
|
|
Nervous system disorders
Stroke
|
10.0%
1/10 • 1 year
|
0.00%
0/10 • 1 year
|
|
Cardiac disorders
Supraventricular tachycardia
|
10.0%
1/10 • 1 year
|
0.00%
0/10 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • 1 year
|
10.0%
1/10 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/10 • 1 year
|
20.0%
2/10 • 1 year
|
|
Psychiatric disorders
Confusion
|
0.00%
0/10 • 1 year
|
10.0%
1/10 • 1 year
|
|
General disorders
Death NOS
|
0.00%
0/10 • 1 year
|
20.0%
2/10 • 1 year
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/10 • 1 year
|
10.0%
1/10 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/10 • 1 year
|
10.0%
1/10 • 1 year
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/10 • 1 year
|
10.0%
1/10 • 1 year
|
|
General disorders
Fatigue
|
0.00%
0/10 • 1 year
|
10.0%
1/10 • 1 year
|
|
General disorders
Gait disturbance
|
0.00%
0/10 • 1 year
|
10.0%
1/10 • 1 year
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/10 • 1 year
|
10.0%
1/10 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/10 • 1 year
|
10.0%
1/10 • 1 year
|
|
Nervous system disorders
Somnolence
|
0.00%
0/10 • 1 year
|
10.0%
1/10 • 1 year
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/10 • 1 year
|
10.0%
1/10 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • 1 year
|
10.0%
1/10 • 1 year
|
Other adverse events
| Measure |
Enoxaparin
n=10 participants at risk
Patients assigned to enoxaparin.
Enoxaparin: Patients will be receive 6 months of subcutaneous enoxaparin (1 mg/kg BID with a maximum starting dose of 100 mg BID. Patients who weigh more than 100 kg will start at a dose of 100 mg BID; their subsequent dosing will be guided by hematology and may change.
|
Aspirin
n=10 participants at risk
Patients assigned to Aspirin.
Aspirin: Patients will receive 6 months of oral aspirin (81 mg per day unless a higher dose is preferred by study physicians although the maximum acceptable dose will be 325 mg per day).
|
|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
10.0%
1/10 • 1 year
|
0.00%
0/10 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • 1 year
|
0.00%
0/10 • 1 year
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
10.0%
1/10 • 1 year
|
0.00%
0/10 • 1 year
|
|
General disorders
Fever
|
10.0%
1/10 • 1 year
|
0.00%
0/10 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.0%
2/10 • 1 year
|
10.0%
1/10 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.0%
1/10 • 1 year
|
0.00%
0/10 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.0%
2/10 • 1 year
|
0.00%
0/10 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.0%
2/10 • 1 year
|
10.0%
1/10 • 1 year
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
10.0%
1/10 • 1 year
|
0.00%
0/10 • 1 year
|
|
Investigations
Lymphocyte count decreased
|
20.0%
2/10 • 1 year
|
20.0%
2/10 • 1 year
|
|
Gastrointestinal disorders
Mucositis oral
|
10.0%
1/10 • 1 year
|
0.00%
0/10 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
10.0%
1/10 • 1 year
|
0.00%
0/10 • 1 year
|
|
Investigations
Neutrophil count decreased
|
20.0%
2/10 • 1 year
|
0.00%
0/10 • 1 year
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.0%
1/10 • 1 year
|
0.00%
0/10 • 1 year
|
|
Investigations
Platelet count decreased
|
10.0%
1/10 • 1 year
|
0.00%
0/10 • 1 year
|
|
Nervous system disorders
Stroke
|
10.0%
1/10 • 1 year
|
0.00%
0/10 • 1 year
|
|
Cardiac disorders
Supraventricular tachycardia
|
10.0%
1/10 • 1 year
|
0.00%
0/10 • 1 year
|
|
Investigations
White blood cell decreased
|
20.0%
2/10 • 1 year
|
0.00%
0/10 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • 1 year
|
10.0%
1/10 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/10 • 1 year
|
20.0%
2/10 • 1 year
|
|
Psychiatric disorders
Confusion
|
0.00%
0/10 • 1 year
|
10.0%
1/10 • 1 year
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/10 • 1 year
|
10.0%
1/10 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/10 • 1 year
|
10.0%
1/10 • 1 year
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/10 • 1 year
|
10.0%
1/10 • 1 year
|
|
General disorders
Fatigue
|
0.00%
0/10 • 1 year
|
10.0%
1/10 • 1 year
|
|
General disorders
Gait disturbance
|
0.00%
0/10 • 1 year
|
10.0%
1/10 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/10 • 1 year
|
10.0%
1/10 • 1 year
|
|
Nervous system disorders
Somnolence
|
0.00%
0/10 • 1 year
|
10.0%
1/10 • 1 year
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/10 • 1 year
|
10.0%
1/10 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • 1 year
|
10.0%
1/10 • 1 year
|
Additional Information
Dr. Lisa DeAngelis, MD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-8000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place