Trial Outcomes & Findings for A Randomized, Open-Label, Parallel-Group, Multi-Center Study for the Evaluation of Efficacy and Safety of Edoxaban Monotherapy Versus Low Molecular Weight (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis (NCT NCT01662908)
NCT ID: NCT01662908
Last Updated: 2019-02-26
Results Overview
Thrombus Volume (mm\^3) was measured at baseline and between days 14 to 21 using MRI results as determined by Magnetic Resonance Venography (MRV) method, and the relative percentage change from baseline was calculated
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
85 participants
Primary outcome timeframe
Baseline to final visit (Day 14-21)
Results posted on
2019-02-26
Participant Flow
From September 2012 through January 2014, a total of 85 patients were enrolled at 26 centers in North America (US and Canada). One subject was not included in either the full analysis set or the safety analysis set because of major protocol violation - he did not take any dose of study drug.
Participant milestones
| Measure |
Edoxaban
Participants treated with edoxaban
|
Warfarin
Participants treated with warfarin
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
28
|
|
Overall Study
COMPLETED
|
50
|
23
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Randomized, Open-Label, Parallel-Group, Multi-Center Study for the Evaluation of Efficacy and Safety of Edoxaban Monotherapy Versus Low Molecular Weight (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis
Baseline characteristics by cohort
| Measure |
Edoxaban
n=56 Participants
Participants treated with edoxaban
|
Warfarin
n=28 Participants
Participants treated with warfarin
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
16 participants
n=5 Participants
|
6 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
22 participants
n=7 Participants
|
62 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to final visit (Day 14-21)Population: Modified intention to treat (mITT), defined as intention to treat minus the one patient who did not take the investigational product
Thrombus Volume (mm\^3) was measured at baseline and between days 14 to 21 using MRI results as determined by Magnetic Resonance Venography (MRV) method, and the relative percentage change from baseline was calculated
Outcome measures
| Measure |
Edoxaban
n=56 Participants
Participants treated with edoxaban
|
Warfarin
n=28 Participants
Participants treated with warfarin
|
|---|---|---|
|
Relative Change From Baseline in Thrombus Volume Assessed by MRI [Using the Magnetic Resonance Venography (MRV) Method]
|
-46.6 percentage of change
Standard Deviation 45.53
|
-51.4 percentage of change
Standard Deviation 32.96
|
SECONDARY outcome
Timeframe: Initial dose of study drug up to 3 days after last dosePopulation: Adjudicated in the mITT population
Clinically relevant bleeding was defined as major or clinically relevant non-major bleeding
Outcome measures
| Measure |
Edoxaban
n=56 Participants
Participants treated with edoxaban
|
Warfarin
n=28 Participants
Participants treated with warfarin
|
|---|---|---|
|
Number of Participants With Clinically Relevant Bleeding
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline to final visit (Day 14-21)Population: mITT
Number of participants with investigator-confirmed recurrent VTE events that start or worsen after the first dose of study drug and prior to the date of the final visit or telephone contact (inclusive)
Outcome measures
| Measure |
Edoxaban
n=56 Participants
Participants treated with edoxaban
|
Warfarin
n=28 Participants
Participants treated with warfarin
|
|---|---|---|
|
Number of Participants With Recurrence of Venous Thromboembolism (VTE)
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Initial dose of study drug up to 3 days after last dosePopulation: Adjudicated confirmed events in the mITT population
MACE is defined as a composite of non-fatal myocardial infarction (MI), non-fatal stroke, non-fatal systemic embolic event (SEE) and cardiovascular death
Outcome measures
| Measure |
Edoxaban
n=56 Participants
Participants treated with edoxaban
|
Warfarin
n=28 Participants
Participants treated with warfarin
|
|---|---|---|
|
Number of Participants With Major Adverse Cardiovascular Events (MACE)
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to final visit (Day 14-21)Population: mITT
Outcome measures
| Measure |
Edoxaban
n=56 Participants
Participants treated with edoxaban
|
Warfarin
n=28 Participants
Participants treated with warfarin
|
|---|---|---|
|
Number of Participants With Change From Baseline in the Presence or Absence of Thrombus by Vessel
|
0 Participants
|
0 Participants
|
Adverse Events
Edoxaban
Serious events: 4 serious events
Other events: 32 other events
Deaths: 0 deaths
Warfarin
Serious events: 4 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Edoxaban
n=56 participants at risk
Participants treated with edoxaban
|
Warfarin
n=28 participants at risk
Participants treated with warfarin
|
|---|---|---|
|
Infections and infestations
Bronchitis
|
1.8%
1/56
|
0.00%
0/28
|
|
Infections and infestations
Urinary Tract Infection
|
1.8%
1/56
|
0.00%
0/28
|
|
Infections and infestations
Urosepsis
|
1.8%
1/56
|
0.00%
0/28
|
|
Infections and infestations
Cellulitis
|
0.00%
0/56
|
3.6%
1/28
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
1.8%
1/56
|
0.00%
0/28
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/56
|
3.6%
1/28
|
|
Nervous system disorders
Tension headache
|
0.00%
0/56
|
3.6%
1/28
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.8%
1/56
|
0.00%
0/28
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/56
|
3.6%
1/28
|
|
Hepatobiliary disorders
Bile duct obstruction
|
1.8%
1/56
|
0.00%
0/28
|
|
Investigations
International normalised ratio increased
|
0.00%
0/56
|
7.1%
2/28
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/56
|
3.6%
1/28
|
Other adverse events
| Measure |
Edoxaban
n=56 participants at risk
Participants treated with edoxaban
|
Warfarin
n=28 participants at risk
Participants treated with warfarin
|
|---|---|---|
|
Infections and infestations
Urinary Tract Infection
|
5.4%
3/56
|
7.1%
2/28
|
|
Infections and infestations
Upper respiratory tract infection
|
3.6%
2/56
|
3.6%
1/28
|
|
Infections and infestations
Clostridium difficile colitis
|
1.8%
1/56
|
0.00%
0/28
|
|
Infections and infestations
Gastroenteritis
|
1.8%
1/56
|
0.00%
0/28
|
|
Infections and infestations
Infected skin ulcer
|
1.8%
1/56
|
0.00%
0/28
|
|
Infections and infestations
Kidney infection
|
1.8%
1/56
|
0.00%
0/28
|
|
Infections and infestations
Oral candidiasis
|
1.8%
1/56
|
0.00%
0/28
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.8%
1/56
|
0.00%
0/28
|
|
Infections and infestations
Sinusitis
|
0.00%
0/56
|
3.6%
1/28
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/56
|
3.6%
1/28
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
1.8%
1/56
|
0.00%
0/28
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
1.8%
1/56
|
0.00%
0/28
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
1.8%
1/56
|
0.00%
0/28
|
|
Blood and lymphatic system disorders
Hypocoagulable state
|
0.00%
0/56
|
3.6%
1/28
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.8%
1/56
|
0.00%
0/28
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
1.8%
1/56
|
0.00%
0/28
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
1.8%
1/56
|
0.00%
0/28
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/56
|
3.6%
1/28
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/56
|
3.6%
1/28
|
|
Psychiatric disorders
Confusional state
|
1.8%
1/56
|
0.00%
0/28
|
|
Psychiatric disorders
Insomnia
|
1.8%
1/56
|
0.00%
0/28
|
|
Psychiatric disorders
Panic attack
|
1.8%
1/56
|
0.00%
0/28
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/56
|
7.1%
2/28
|
|
Nervous system disorders
Dizziness
|
5.4%
3/56
|
7.1%
2/28
|
|
Nervous system disorders
Headache
|
3.6%
2/56
|
7.1%
2/28
|
|
Nervous system disorders
Dysgeusia
|
1.8%
1/56
|
0.00%
0/28
|
|
Nervous system disorders
Hypoaesthesia
|
1.8%
1/56
|
0.00%
0/28
|
|
Nervous system disorders
Neuritis
|
1.8%
1/56
|
0.00%
0/28
|
|
Nervous system disorders
Tension headache
|
1.8%
1/56
|
0.00%
0/28
|
|
Nervous system disorders
Tremor
|
1.8%
1/56
|
0.00%
0/28
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/56
|
3.6%
1/28
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/56
|
3.6%
1/28
|
|
Eye disorders
Conjunctivitis allergic
|
1.8%
1/56
|
0.00%
0/28
|
|
Eye disorders
Visual impairment
|
1.8%
1/56
|
0.00%
0/28
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/56
|
3.6%
1/28
|
|
Cardiac disorders
Palpitations
|
1.8%
1/56
|
0.00%
0/28
|
|
Cardiac disorders
Ventricular tachycardia
|
1.8%
1/56
|
0.00%
0/28
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/56
|
3.6%
1/28
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/56
|
3.6%
1/28
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/56
|
3.6%
1/28
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/56
|
3.6%
1/28
|
|
Vascular disorders
Hypertension
|
3.6%
2/56
|
0.00%
0/28
|
|
Vascular disorders
Haematoma
|
1.8%
1/56
|
0.00%
0/28
|
|
Vascular disorders
Hypotension
|
1.8%
1/56
|
0.00%
0/28
|
|
Vascular disorders
Lymphoedema
|
1.8%
1/56
|
0.00%
0/28
|
|
Vascular disorders
Post thrombotic syndrome
|
1.8%
1/56
|
0.00%
0/28
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.8%
1/56
|
7.1%
2/28
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.8%
1/56
|
0.00%
0/28
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/56
|
7.1%
2/28
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/56
|
3.6%
1/28
|
|
Gastrointestinal disorders
Nausea
|
7.1%
4/56
|
10.7%
3/28
|
|
Gastrointestinal disorders
Vomiting
|
5.4%
3/56
|
0.00%
0/28
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.6%
2/56
|
0.00%
0/28
|
|
Gastrointestinal disorders
Constipation
|
1.8%
1/56
|
0.00%
0/28
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
1/56
|
0.00%
0/28
|
|
Gastrointestinal disorders
Diverticulum
|
1.8%
1/56
|
0.00%
0/28
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
1.8%
1/56
|
0.00%
0/28
|
|
Gastrointestinal disorders
Dyspepsia
|
1.8%
1/56
|
0.00%
0/28
|
|
Gastrointestinal disorders
Epigastric discomfort
|
1.8%
1/56
|
0.00%
0/28
|
|
Gastrointestinal disorders
Flatulence
|
1.8%
1/56
|
0.00%
0/28
|
|
Gastrointestinal disorders
Gastric polyps
|
1.8%
1/56
|
0.00%
0/28
|
|
Gastrointestinal disorders
Gingival bleeding
|
1.8%
1/56
|
0.00%
0/28
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
1.8%
1/56
|
0.00%
0/28
|
|
Gastrointestinal disorders
Loose tooth
|
1.8%
1/56
|
0.00%
0/28
|
|
Gastrointestinal disorders
Proctalgia
|
1.8%
1/56
|
0.00%
0/28
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/56
|
3.6%
1/28
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/56
|
3.6%
1/28
|
|
Hepatobiliary disorders
Hepatic steatosis
|
1.8%
1/56
|
0.00%
0/28
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.6%
2/56
|
3.6%
1/28
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.6%
2/56
|
3.6%
1/28
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.8%
1/56
|
3.6%
1/28
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.8%
1/56
|
0.00%
0/28
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
1.8%
1/56
|
0.00%
0/28
|
|
Skin and subcutaneous tissue disorders
Skln ulcer
|
1.8%
1/56
|
0.00%
0/28
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.8%
1/56
|
0.00%
0/28
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
1.8%
1/56
|
0.00%
0/28
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.8%
1/56
|
0.00%
0/28
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
1.8%
1/56
|
0.00%
0/28
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/56
|
3.6%
1/28
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/56
|
3.6%
1/28
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/56
|
3.6%
1/28
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/56
|
10.7%
3/28
|
|
Renal and urinary disorders
Renal cyst
|
3.6%
2/56
|
0.00%
0/28
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.8%
1/56
|
0.00%
0/28
|
|
Reproductive system and breast disorders
Prostatomegaly
|
1.8%
1/56
|
0.00%
0/28
|
|
General disorders
Oedema peripheral
|
5.4%
3/56
|
7.1%
2/28
|
|
General disorders
Fatigue
|
3.6%
2/56
|
3.6%
1/28
|
|
General disorders
Pyrexia
|
3.6%
2/56
|
0.00%
0/28
|
|
General disorders
Injection site haematoma
|
1.8%
1/56
|
0.00%
0/28
|
|
General disorders
Non-cardiac chest pain
|
1.8%
1/56
|
0.00%
0/28
|
|
General disorders
Oedema
|
1.8%
1/56
|
0.00%
0/28
|
|
General disorders
Asthenia
|
0.00%
0/56
|
3.6%
1/28
|
|
Investigations
Hepatic enzyme increased
|
3.6%
2/56
|
7.1%
2/28
|
|
Investigations
Blood alkaline phosphatase increased
|
1.8%
1/56
|
0.00%
0/28
|
|
Investigations
Epstein-Barr virus antibody positive
|
1.8%
1/56
|
0.00%
0/28
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/56
|
3.6%
1/28
|
|
Investigations
Liver function test abnormal
|
0.00%
0/56
|
3.6%
1/28
|
|
Injury, poisoning and procedural complications
Procedural pain
|
3.6%
2/56
|
3.6%
1/28
|
|
Injury, poisoning and procedural complications
Arthopod bite
|
1.8%
1/56
|
0.00%
0/28
|
|
Injury, poisoning and procedural complications
Contrast media reaction
|
1.8%
1/56
|
0.00%
0/28
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
1.8%
1/56
|
0.00%
0/28
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/56
|
3.6%
1/28
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/56
|
3.6%
1/28
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/56
|
7.1%
2/28
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/56
|
3.6%
1/28
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/56
|
3.6%
1/28
|
Additional Information
Senior Director, CVM TA Development
Daiichi Sankyo, Inc.
Phone: 732-590-5000
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER