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Factor Xa Inhibitor

Rivaroxaban (Xarelto, BAY59-7939) for Deep Vein Thrombosis

Phase 3
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Patients with confirmed symptomatic PE or DVT who have been treated for 6 or 12 months with VKA or rivaroxaban
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6- or 12-month study treatment period
Awards & highlights
All Individual Drugs Already Approved
Approved for 20 Other Conditions
Pivotal Trial

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT (deep vein thrombosis) or PE (pulmonary embolism) who completed 6 or 12 months of treatment with rivaroxaban or VKA (vitamin K antagonist) are eligible for this trial (Einstein-Extension study).

Eligible Conditions
  • Deep Vein Thrombosis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6- or 12-month study treatment period
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6- or 12-month study treatment period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pulmonary Embolism
Secondary study objectives
Percentage of Participants With All Death
Percentage of Participants With Clinically Relevant Bleeding
Percentage of Participants With Major Bleeding
+6 more
Other study objectives
Percentage of Participants With Death (PE Cannot be Excluded) Until the Intended End of Study Treatment
Percentage of Participants With Death (PE) Until the Intended End of Study Treatment
Hemorrhage
+7 more

Side effects data

From 2019 Phase 3 trial • 500 Patients • NCT02234843
15%
Headache
12%
Epistaxis
9%
Pyrexia
8%
Vomiting
7%
Diarrhoea
7%
Cough
6%
Abdominal pain
6%
Constipation
6%
Pain in extremity
6%
Nasopharyngitis
6%
Contusion
5%
Injection site bruising
5%
Upper respiratory tract infection
4%
Nausea
4%
Fatigue
4%
Alanine aminotransferase increased
3%
Subcutaneous haematoma
3%
Anaemia
3%
Alopecia
3%
Puncture site haemorrhage
3%
Menorrhagia
3%
Chest pain
2%
Increased tendency to bruise
2%
Pharyngitis
2%
Dizziness
2%
Rectal haemorrhage
2%
Injection site haematoma
2%
Head injury
2%
Arthralgia
2%
Neutropenia
2%
Abdominal pain upper
2%
Rhinitis
2%
Tonsillitis
2%
Papilloedema
2%
Nasal congestion
2%
Oropharyngeal pain
2%
Rash
2%
Back pain
2%
Peripheral swelling
2%
Influenza
2%
Ligament sprain
1%
Musculoskeletal pain
1%
Craniopharyngioma
1%
Leukopenia
1%
Road traffic accident
1%
Lymphadenopathy
1%
Diplopia
1%
Catheter site rash
1%
Haematoma
1%
Vessel puncture site haemorrhage
1%
Implant site infection
1%
Blood thyroid stimulating hormone increased
1%
Varicella
1%
Tongue blistering
1%
Toothache
1%
Paronychia
1%
Neck pain
1%
Traumatic haemothorax
1%
Tongue geographic
1%
Granuloma
1%
Hemianaesthesia
1%
Faecaloma
1%
Myalgia
1%
Abdominal hernia
1%
Pneumonia mycoplasmal
1%
Intracranial pressure increased
1%
Cushingoid
1%
Lymphangioma
1%
Costochondritis
1%
Perineal erythema
1%
Hypothermia
1%
Lipoprotein (a) increased
1%
Dental caries
1%
Oral pain
1%
Stomatitis
1%
Coagulation factor VIII level increased
1%
Nephrolithiasis
1%
Ear infection viral
1%
Vaginal haemorrhage
1%
Herpes zoster
1%
Flank pain
1%
Vision blurred
1%
Periodontitis
1%
Transaminases increased
1%
Peritonitis
1%
Pneumonia
1%
Joint injury
1%
Skin papilloma
1%
Gastrooesophageal reflux disease
1%
Pharyngitis streptococcal
1%
Incision site haematoma
1%
Febrile neutropenia
1%
Encephalitis autoimmune
1%
Postoperative wound infection
1%
Skin abrasion
1%
Vascular access site haemorrhage
1%
Aspartate aminotransferase increased
1%
Hyperglycaemia
1%
Hypertriglyceridaemia
1%
Gastroenteritis norovirus
1%
Infected dermal cyst
1%
Sickle cell anaemia with crisis
1%
Seizure
1%
Atrial tachycardia
1%
Vertigo
1%
Pancreatitis
1%
Gastroenteritis
1%
Pneumonia viral
1%
Tonsillitis streptococcal
1%
Subdural haemorrhage
1%
Cerebral infarction
1%
Diaphragmatic paralysis
1%
Pleural effusion
1%
Thrombocytopenia
1%
Autoimmune neutropenia
1%
Bradycardia
1%
Palpitations
1%
Sinus tachycardia
1%
Supraventricular tachycardia
1%
Ear haemorrhage
1%
Ear pain
1%
Ear discomfort
1%
Glaucoma
1%
Heterophoria
1%
Retinal haemorrhage
1%
Eye pruritus
1%
Abdominal discomfort
1%
Abdominal distension
1%
Flatulence
1%
Influenza like illness
1%
Injection site extravasation
1%
Injection site induration
1%
Injection site mass
1%
Catheter site haemorrhage
1%
Vaccination site pain
1%
Medical device site haemorrhage
1%
Cholangitis
1%
Cholelithiasis
1%
Hypertransaminasaemia
1%
Anaphylactic reaction
1%
Angular cheilitis
1%
Cellulitis
1%
Conjunctivitis
1%
Ear infection
1%
Eyelid infection
1%
Giardiasis
1%
Urinary tract infection
1%
Viral upper respiratory tract infection
1%
Escherichia urinary tract infection
1%
Gastrointestinal viral infection
1%
Alcohol poisoning
1%
Arthropod bite
1%
Concussion
1%
Fall
1%
Anaphylactic transfusion reaction
1%
Cerebral radiation injury
1%
Blood bilirubin increased
1%
Blood glucose decreased
1%
Oxygen saturation decreased
1%
Platelet count decreased
1%
White blood cell count decreased
1%
Anticoagulation drug level below therapeutic
1%
Vitamin D decreased
1%
Influenza A virus test positive
1%
Iron deficiency
1%
Vitamin B12 deficiency
1%
Vitamin D deficiency
1%
Pain in jaw
1%
Neuropathy peripheral
1%
Syncope
1%
Tension headache
1%
Choroid fissure cyst
1%
Attention deficit/hyperactivity disorder
1%
Mood altered
1%
Post stroke depression
1%
Haematuria
1%
Breast mass
1%
Menstruation irregular
1%
Metrorrhagia
1%
Vaginal discharge
1%
Dyspnoea
1%
Dyspnoea exertional
1%
Haemoptysis
1%
Nasal obstruction
1%
Tonsillar hypertrophy
1%
Mediastinal cyst
1%
Respiratory symptom
1%
Acne
1%
Ecchymosis
1%
Erythema
1%
Hirsutism
1%
Pruritus
1%
Rash maculo-papular
1%
Rash papular
1%
Skin discolouration
1%
Umbilical haemorrhage
1%
Urticaria
1%
Ventricular drainage
1%
Arterial thrombosis
1%
Hypertension
1%
Superficial vein prominence
1%
May-Thurner syndrome
1%
Device leakage
1%
Device occlusion
1%
Gastroenteritis viral
1%
Rash follicular
1%
Small intestinal obstruction
1%
Bacterial sepsis
1%
Incorrect route of product administration
1%
Pancytopenia
1%
Human rhinovirus test positive
1%
Liver function test increased
1%
Folate deficiency
1%
Selenium deficiency
1%
Hyperhomocysteinaemia
1%
Urine odour abnormal
1%
Acute kidney injury
1%
Sneezing
1%
Respiratory tract congestion
1%
Sinus disorder
1%
Skin haemorrhage
1%
Mastoid operation
1%
Phlebitis
1%
Extremity necrosis
1%
Muscular dystrophy
1%
Drug clearance decreased
1%
Meningitis
1%
Accidental overdose
1%
Pneumonitis
1%
Pulmonary vein stenosis
1%
Colostomy
1%
Tongue coated
1%
Injection site pruritus
1%
Malaise
1%
Impetigo
1%
Oral candidiasis
1%
Otitis media
1%
Sinusitis
1%
Subcutaneous abscess
1%
Vulvitis
1%
Postoperative thoracic procedure complication
1%
Procedural pain
1%
Thrombocytosis
1%
Cytopenia
1%
Hyponatraemia
1%
Strabismus
1%
Gingival bleeding
1%
Anxiety
1%
Dysuria
1%
Injection site haemorrhage
1%
Non-cardiac chest pain
1%
Rhinorrhoea
1%
Pulmonary pain
1%
Folliculitis
1%
Otitis media acute
1%
Viral infection
1%
Wound haemorrhage
1%
Anticoagulation drug level above therapeutic
1%
Bone pain
1%
Tremor
1%
Nervousness
1%
Pollakiuria
1%
Dysmenorrhoea
1%
Genital rash
1%
Dermatitis allergic
1%
Eczema
1%
Night sweats
1%
Rash pruritic
1%
Gastrointestinal tube insertion
1%
Nodule
1%
Hordeolum
1%
Paraesthesia
1%
Sclerotherapy
1%
Eye pain
1%
Haematochezia
1%
Rhinitis allergic
1%
Dermatitis contact
1%
Dermatitis diaper
1%
Immunodeficiency congenital
1%
Asthenia
1%
Oedema peripheral
1%
Serum sickness
1%
Cardiac infection
1%
Tinea versicolour
1%
Asymptomatic bacteriuria
1%
Catheter site infection
1%
Mastoid abscess
1%
Injection site infection
1%
Tibia fracture
1%
Transfusion reaction
1%
Exposure to communicable disease
1%
Stoma site rash
1%
Full blood count abnormal
1%
International normalised ratio abnormal
1%
Depression
1%
Disorientation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Comparator Group
Rivaroxaban Group

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Rivaroxaban (Xarelto, BAY59-7939)Experimental Treatment1 Intervention
Participants were to receive rivaroxaban 20 mg oral tablet once daily
Group II: PlaceboPlacebo Group1 Intervention
Participants were to receive matching placebo oral tablet once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rivaroxaban
FDA approved

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,270 Previous Clinical Trials
25,513,483 Total Patients Enrolled
8 Trials studying Deep Vein Thrombosis
23,909 Patients Enrolled for Deep Vein Thrombosis
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry Sponsor
514 Previous Clinical Trials
843,462 Total Patients Enrolled
1 Trials studying Deep Vein Thrombosis
25 Patients Enrolled for Deep Vein Thrombosis
Bayer Study DirectorStudy DirectorBayer
1,180 Previous Clinical Trials
4,260,669 Total Patients Enrolled
5 Trials studying Deep Vein Thrombosis
7,830 Patients Enrolled for Deep Vein Thrombosis
~64 spots leftby Oct 2025
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