ENhanced Recovery and ABbreviated LEngth of Anticoagulation for Thromboprophylaxis After Primary Hip Arthroplasty

ENhanced Recovery and ABbreviated LEngth of Anticoagulation for Thromboprophylaxis After Primary Hip Arthroplasty (NCT06611319) is a Phase 3 interventional studying Hip Arthroplasty, Total and Prevention of Venous Thromboembolism, sponsored by Prof. Stavros Konstantinides, MD. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Hip Arthroplasty, Total, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 2,932 participants makes this one of the larger Hip Arthroplasty, Total trials currently registered. Trials at this scale are typically global, run across many sites, and designed to generate the definitive evidence package for an FDA approval submission or a label expansion.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Written willing to sign a consent form 2. Age between 18 and 85 years 3. Scheduled to undergo elective unilateral primary THA and eligible for perioperative management based on the ERAS protocol 4. Baseline Timed Up and Go (TUG) test scoring \&lt; 20 seconds, corresponding to a good mobility status before surgery 5. Capability to understand and comply with the protocol requirements (e.g., sufficient knowledge of German language to answer the questionnaires, ability to swallow intact capsules). 6. Pregnancy and contraception: 1. Pregnancy test: Negative serum pregnancy test at screening for women of childbearing potential (WOCBP). 2. Contraception: WOCBP and men who are able to father a child, willing to be abstinent or use highly effective methods of birth control that result in a low failure rate of less than 1% per year when used consistently and correctly beginning at willing to sign a consent form, for the duration of drug treatment and allowing for a safe wash out period of at least 5 days for female or for male subjects after the last dose of trial medication. This is a very conservative estimate, considering the 'worst case scenario' of a substantially prolonged half-life up to 13 hours (e.g., in older patients and/or those with renal dysfunction) (28), and calculating for at least 8 half-lives to ensure practically non-detectable levels and effects of rivaroxaban. Who Should NOT Join This Trial: 1. Previous DVT or PE 2. Hip or lower limb fracture in the previous three months 3. Major surgical procedure within the previous three months 4. Active cancer defined as metastatic cancer, or cancer requiring chemotherapy or radiation therapy 5. Active peptic ulcer disease, gastritis, or prior gastrointestinal bleeding 6. Obesity with body mass index (BMI) \&gt; 40 kg/m2 body surface area 7. Severe renal impairment defined as estimated glomerular filtration rate \&lt; 30ml/min ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Written informed consent 2. Age between 18 and 85 years 3. Scheduled to undergo elective unilateral primary THA and eligible for perioperative management based on the ERAS protocol 4. Baseline Timed Up and Go (TUG) test scoring \&lt; 20 seconds, corresponding to a good mobility status before surgery 5. Capability to understand and comply with the protocol requirements (e.g., sufficient knowledge of German language to answer the questionnaires, ability to swallow intact capsules). 6. Pregnancy and contraception: 1. Pregnancy test: Negative serum pregnancy test at screening for women of childbearing potential (WOCBP). 2. Contraception: WOCBP and men who are able to father a child, willing to be abstinent or use highly effective methods of birth control that result in a low failure rate of less than 1% per year when used consistently and correctly beginning at informed consent, for the duration of drug treatment and allowing for a safe wash out period of at least 5 days for female or for male subjects after the last dose of trial medication. This is a very conservative estimate, considering the 'worst case scenario' of a substantially prolonged half-life up to 13 hours (e.g., in older patients and/or those with renal dysfunction) (28), and calculating for at least 8 half-lives to ensure practically non-detectable levels and effects of rivaroxaban. Exclusion Criteria: 1. Previous DVT or PE 2. Hip or lower limb fracture in the previous three months 3. Major surgical procedure within the previous three months 4. Active cancer defined as metastatic cancer, or cancer requiring chemotherapy or radiation therapy 5. Active peptic ulcer disease, gastritis, or prior gastrointestinal bleeding 6. Obesity with body mass index (BMI) \&gt; 40 kg/m2 body surface area 7. Severe renal impairment defined as estimated glomerular filtration rate \&lt; 30ml/min 8. Severe hepatic impairment defined as Child Pugh Class B or C 9. Uncontrolled intercurrent illness (i.e., active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, interstitial lung disease, serious gastrointestinal conditions \[e.g., diarrhea, malabsorption\], psychiatric illness) 10. Active or recent major bleeding at any site, or presence of any major risk factor for bleeding, which, in the judgment of the investigator, may significantly increase the bleeding risk during postoperative anticoagulation treatment 11. Any other medical condition representing a contraindication to discharge within 6 days after surgery 12. Expected requirement for major surgery within a 90-day period post THA 13. Need for long-term anticoagulation (e.g., atrial fibrillation, previous VTE) 14. Need for chronic antiplatelet therapy except for acetylsalicylic acid (ASA) at a dose ≤ 100 mg daily or clopidogrel 75 mg daily 15. Previous participation in this trial 16. Life expectancy \&lt; 6 months 17. Participation in another interventional clinical trial within the last 30 days prior to inclusion, unless during the observational follow-up period 18. History of hypersensitivity to the investigational medicinal product (IMP) or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the IMP

Treatments Being Tested

DRUG

Prevention of Venous Thromboembolism

Direct oral anticoagulant

DRUG

Placebo Oral Tablet

Placebo

Locations (6)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Kepler University Medical Center, Orthopedics and Traumatology

Linz, Upper Austria, Austria

Sana Clinics Sommerfeld, Dpt. for Surgical Orthopaedics

Kremmen, Brandenburg, Germany

GPR Rüsselsheim Health and Care Center

Rüsselsheim am Main, Hesse, Germany

University Medical Center Mainz, Center for Orthopedics and Trauma Surgery

Mainz, Rhineland-Palatine, Germany

University Medical Center Dresden, University Center for Orthopaedics, Trauma & Plastic Surgery

Dresden, Saxony, Germany

Evangelical Forest Hospital Berlin - Orthopaedics and Trauma Surgery

Berlin, Germany

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06611319), the sponsor (Prof. Stavros Konstantinides, MD), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06611319 clinical trial studying?

Who can participate in NCT06611319?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06611319?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06611319. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06611319. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.