A Phase 3 interventional study of Prevention of Venous Thromboembolism and Placebo Oral Tablet in Hip Arthroplasty, Total and Prevention of Venous Thromboembolism, sponsored by Prof. Stavros Konstantinides, MD. Recruiting at 6 sites in 2 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-01-16.
Sponsored by Prof. Stavros Konstantinides, MD · Phase 3, Interventional, and Prevention
Among 20 studies testing rivaroxaban in Pulmonary Embolism — 4 open to participants now, 6 under way, 2 of them phase 3. Rivaroxaban · Pulmonary Embolism.
Among the 20 studies testing rivaroxaban in Pulmonary Embolism, this one is the 6th largest by planned enrollment, is one of 3 that started in 2024, is one of 7 in phase 3, and was the 19th registered.
832 studies on the registry are indexed under Pulmonary Embolism; 171 are open to participants now.
This study's planned enrollment of 2,932 is above the median of 174 across 429 interventional studies indexed under Pulmonary Embolism.
Browse Pulmonary Embolism studies →4 of the 20 studies testing rivaroxaban in Pulmonary Embolism are open now, in 8 countries. Each count lists the studies.
Rivaroxaban: first FDA approval 2011 (XARELTO), first EMA approval 2008. What it is approved for, and how studies give it, is on its page →
Of the 129 Pulmonary Embolism studies recruiting now, 109 (84%) set no upper age limit and 5 (4%) stop at 75 or younger; 9 take children under 18; 9 take healthy volunteers.
This study: 18 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →20 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 3 started in 2024.
Median enrollment 241 across the 20 interventional studies. Of the 14 that completed or were terminated, 7 (50%) have results posted.
7 of 20 have an industry lead sponsor. The 10 most frequent:
Prof. Stavros Konstantinides, MD is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Prof. Stavros Konstantinides, MD has 2 studies filed under Pulmonary Embolism — fewer than ten, so there is no comparison to draw.
2 of the studies testing rivaroxaban in Pulmonary Embolism that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06611319Phase 3Prof. Stavros Konstantinides, MDENhanced Recovery and ABbreviated LEngth of Anticoagulation for Thromboprophylaxis After Primary Hip Arthroplasty | 2027-03 |
| NCT03129555Herlev and Gentofte HospitalThe Danish Non-vitamin K Antagonist Oral Anticoagulation Study in Patients With Venous Thromboembolism (DANNOAC-VTE) | 2027-03-31 |
Among the 20 studies testing rivaroxaban in Pulmonary Embolism, from their registry updates:
Nothing recorded among them since 2026-09-25.
Surgical hip replacement (total hip arthroplasty, THA) is associated with a high risk of venous thromboembolism, but the appropriate duration of postoperative medical thromboprophylaxis ("anticoagulation") remains highly controversial. The international randomized controlled trial (RCT) "ENhanced recovery and ABbreviated LEngth of Anticoagulation for Thromboprophylaxis after primary Hip Arthroplasty" (ENABLE-Hip) will enroll patients undergoing elective THA that are eligible for early mobilization after surgery. The trial will compare a regimen of short-duration (10-day) postoperative anticoagulation (experimental group) to standard-duration (35-day) postoperative anticoagulation (control group) using the direct oral anticoagulant Rivaroxaban (brand name: Xarelto) at the recommended dose. Thus, ENABLE-Hip will be the first major RCT to directly test an overall reduction in the duration of post-THA thromboprophylaxis instead of replacing one antithrombotic drug or regimen by another. Follow-up visits after hospital discharge will be on day 35 and on day 90 after surgery. The primary outcome is acute symptomatic proximal deep vein thrombosis, or symptomatic or fatal pulmonary embolism, within 90 days after surgery. If ENABLE-Hip will demonstrate 'non-inferiority' of the experimental intervention, its benefits will be obvious, as patients are spared many days of unnecessary (and potentially harmful in terms of bleeding risk) anticoagulation.
An increasing proportion of the ageing population in Europe and other parts of the world suffers from hip osteoarthritis and will need surgical joint arthroplasty at some time in their lives. Surgical total hip arthroplasty (THA) is associated with a high risk of venous thromboembolism (VTE), but the appropriate duration of postoperative anticoagulation remains highly controversial. Although current German guidelines continue to advocate anticoagulation for 28-35 days after THA, clinical practice recommendations in other countries are shifting towards much earlier discontinuation of anticoagulants - despite the absence of solid evidence backed by controlled data. The "Enhanced recovery and Abbreviated duration of Anticoagulation for thromboprophylaxis after primary hip Arthroplasty" (ENABLE-Hip) study is a multicentre investigator-initiated and academically sponsored prospective randomised active-control non-inferiority trial. A regimen of short-duration (10-day) prophylactic anticoagulation (experimental arm) will be compared to standard-duration (35-day) anticoagulation as per current guidelines (control arm). Patients will be mobilised early after surgery, following a standardised enhanced recovery protocol. Following randomisation and an initial two-day open-label period of prophylactic anticoagulation as per local protocol, treatment with the study drug (rivaroxaban at the standard, approved prophylactic dose of 10 mg daily) will be started and continued until 10 days after surgery. After this time, patients will be switched (in a double-blinded manner) to placebo in the experimental arm, or continue on active drug in the control arm, until a total of 35 days have elapsed since surgery. The primary outcome is acute symptomatic proximal deep vein thrombosis (DVT), or symptomatic or fatal pulmonary embolism (PE), within the first 3 months after surgery. Participating investigators will be advised to adhere to guideline recommendations regarding clinical suspicion of and diagnostic work-up for VTE. The planned study population of 2,932 patients will provide ≥ 80% power to reject the null hypothesis that δ ≥ 0.01 (where δ = difference between the two arms in symptomatic VTE probability within 3 months) and accept the alternative hypothesis that δ \< 0.01, at an overall significance level α = 0.05. A formal interim analysis will be performed after 3-month follow-up of the first 1,760 randomised patients at a significance level α = 0.50, leading to stopping for futility if significance is not obtained, or if recalculation yields an overall sample size of > 3,200 patients. The trial has the potential to inform future national and European guidelines for this large and continuously growing patient population.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Pregnancy and :
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Rivaroxaban from day 3-10; Placebo from day 11-35 after surgery
Drug: Prevention of Venous Thromboembolism · Drug: Placebo Oral Tablet
Rivaroxaban from day 3-35 after surgery
Drug: Prevention of Venous Thromboembolism
Direct oral anticoagulant
Also known as: Rivaroxaban, Xarelto, anticoag, Direct oral anticoagulant, DOAC
Placebo
The primary efficacy endpoint is the rate of acute symptomatic or fatal VTE
acute symptomatic or fatal VTE, defined as (i) symptomatic DVT of the popliteal or more proximal leg veins (femoral or iliac veins) or inferior vena cava; or (ii) symptomatic (segmental or more proximal) or fatal PE, occurring in the first 90 days after surgery and confirmed by objective testing.
Time frame: within 90 days after surgery
Length of hospital stay
duration of inpatient stay
Time frame: within 90 days after surgery
Changes in patient-reported hip joint-specific disability
assessment is made following surgery measured by the HOOS-12 score
Time frame: within 90 days after surgery
Rate of clinically relevant non-major bleedings
it does not meet the criteria for major bleeding, but results in hospitalization, aspiration of a wound, or a wound hematoma complicated by infection.
Time frame: within 90 days after surgery
Rate of death from any cause
rate of death from any cause
Time frame: within 90 days after surgery
Rate of isolated symptomatic distal DVT
rate of symptomatic distal DVT
Time frame: within 90 days after surgery
Rate of myocardial infarction (MI) or stroke
rate of MI or stroke
Time frame: within 90 days after surgery
Rate of readmission to the hospital
rate of readmissions to the hospital
Time frame: within 90 days after surgery
Number and terms of serious adverse events (SAEs)
number of SAEs during study duration
Time frame: within 90 days after surgery
Change in patient mobility
measured by Range of motion (ROM) and Timed up and Go (TUG) score
Time frame: within 90 days after surgery
Amount of postoperative healthcare resource utilization
visits to health care providers and rehospitalization, employment status
Time frame: within 35 days after surgery
Rate of major bleedings
fulfils at least one of the following criteria: (i) fatal (ii) bleeding into a critical area or organ (iii) surgical site bleeding that causes hemodynamic instability (iv) non-surgical site bleeding causing a fall in hemoglobin level of ≥ 20 g L-1, or leading to transfusion of ≥ 2 units of whole blood or red blood cells (v) surgical site bleeding that requires a second intervention (open, arthroscopic, endovascular), or hemarthron of sufficient size to delay mobilization or wound healing
Time frame: within 90 days after surgery
Generic quality of life measured by EQ-5D-5L
The EQ-5D is not an abbreviation and is the correct term to use in print or verbally. EQ-5D-5L consists of 2 parts: 1. descriptive system consists of 5 dimensions with 5 levels each. A score of 5 at a minimum means best health state; a score of 25 at a maximum means worst health state. 2. EQ VAS: a scale from 0 (worst health state) to 100 (best health state) is provided. This questionnaire is to be completed by the patient for the current day.
Time frame: within 90 days after surgery
Plan to share: No
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Studies of the drug tested here: Rivaroxaban
Prof. Stavros Konstantinides, MD