Clinical trial • Phase III • Musculoskeletal

RIVAROXABAN for Hip osteoarthritis

Phase III trial of RIVAROXABAN for Hip osteoarthritis.

Overview

Trial Therapeutic Area
Musculoskeletal
Trial Disease
Hip osteoarthritis
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
29-04-2024
First CTIS Authorization Date
31-07-2024

Trial design

Randomised, open-label, experimental: rivaroxaban at the approved prophylactic dose of 10 mg once daily started on postoperative day 3 and continued for 8 days (up to day 10), then switched (double-blind) to placebo for 25 days (up to day 35). control: rivaroxaban at the approved prophylactic dose of 10 mg once daily started on postoperative day 3 and continued for 8 days (up to day 10), then continued (double-blind) to receive rivaroxaban 10 mg once daily for 25 days (up to day 35). Phase III trial across 9 sites in Germany, Austria.

Randomised
Yes
Open Label
Yes
Comparator
Experimental: Rivaroxaban at the approved prophylactic dose of 10 mg once daily started on postoperative day 3 and continued for 8 days (up to day 10), then switched (double-blind) to placebo for 25 days (up to day 35). Control: Rivaroxaban at the approved prophylactic dose of 10 mg once daily started on postoperative day 3 and continued for 8 days (up to day 10), then continued (double-blind) to receive rivaroxaban 10 mg once daily for 25 days (up to day 35).
Target Sample Size
5000
Trial Duration For Participant
125

Stratification factors

  • Site (randomisation performed per site; block randomisation with varying block length)

Eligibility

Recruits 5000 Vulnerable population flag selected. Only adults (age 18–85) are eligible; written informed consent required from the participant. Capability to understand and comply (e.g., sufficient knowledge of German language to answer questionnaires) is required. Adult ICF documents are provided (country-specific adult ICFs listed for DE and AT)..

Pregnancy Exclusion
Negative serum pregnancy test and highly effective method of contraception for the duration of study treatment
Vulnerable Population
Vulnerable population flag selected. Only adults (age 18–85) are eligible; written informed consent required from the participant. Capability to understand and comply (e.g., sufficient knowledge of German language to answer questionnaires) is required. Adult ICF documents are provided (country-specific adult ICFs listed for DE and AT).

Inclusion criteria

  • {"criterion_text":"- Written informed consent"}
  • {"criterion_text":"- Age between 18 and 85 years"}
  • {"criterion_text":"- Scheduled to undergo elective unilateral primary THA and eligible for perioperative management as per fast-track protocol including early mobilization and discharge from the hospital after surgery"}
  • {"criterion_text":"- Baseline Timed Up and Go (TUG) test scoring < 20 seconds, corresponding to a good mobility status before surgery"}
  • {"criterion_text":"- 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)"}
  • {"criterion_text":"- Negative serum pregnancy test and highly effective method of contraception for the duration of study treatment"}

Exclusion criteria

  • {"criterion_text":"- Previous DVT or PE"}
  • {"criterion_text":"- Active or recent major bleeding at any site, or presence of any major risk factor, which, in the judgment of the investigator, may significantly increase the bleeding risk during postoperative anticoagulation treatment"}
  • {"criterion_text":"- Any medical condition representing a contraindication to discharge within 6 days after surgery"}
  • {"criterion_text":"- Expected requirement for major surgery within a 90-day period post THA"}
  • {"criterion_text":"- Need for long-term anticoagulation (e.g., atrial fibrillation, previous VTE)"}
  • {"criterion_text":"- Need for chronic antiplatelet therapy except for acetylsalicylic acid (ASA) at a dose f100 mg daily or clopidogrel 75 mg daily"}
  • {"criterion_text":"- Previous participation in this trial"}
  • {"criterion_text":"- Life expectancy < 6 months"}
  • {"criterion_text":"- Participation in another interventional clinical trial at inclusion or within the last 30 days prior to inclusion, except during the observational follow-up period of that other trial"}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- Hip or lower limb fracture in the previous three months"}
  • {"criterion_text":"- Major surgical procedure within the previous three months"}
  • {"criterion_text":"- Active cancer defined as metastatic cancer or cancer requiring chemotherapy or radiation therapy within the past six months"}
  • {"criterion_text":"- Active peptic ulcer disease or gastritis, or gastrointestinal bleeding within the past three months"}
  • {"criterion_text":"- Obesity with body mass index (BMI) > 40 kg/m² body surface area"}
  • {"criterion_text":"- Severe renal impairment defined as estimated glomerular filtration rate < 30ml/min"}
  • {"criterion_text":"- Severe hepatic impairment defined as Child Pugh Class B or C"}
  • {"criterion_text":"- 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)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Participation in another interventional clinical trial at inclusion or within the last 30 days prior to inclusion, except during the observational follow-up period of that other trial","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Death from any cause","definition_or_measurement_approach":""}
  • {"endpoint_text":"- isolated symptomatic distal DVT","definition_or_measurement_approach":""}
  • {"endpoint_text":"- myocardial infarction or stroke","definition_or_measurement_approach":""}
  • {"endpoint_text":"- need for readmission to the hospital and length of hospital stay;","definition_or_measurement_approach":""}
  • {"endpoint_text":"- serious adverse events (SAEs)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- patient mobility","definition_or_measurement_approach":""}
  • {"endpoint_text":"- changes in patientreported hip joint-specific disability following surgery","definition_or_measurement_approach":""}
  • {"endpoint_text":"- generic quality of life","definition_or_measurement_approach":""}
  • {"endpoint_text":"- postoperative healthcare resource utilization within the first 35 days after surgery","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Overt major or clinically relevant non-major bleeding","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
5000
Recruitment Window Months
37
Consent Approach
Written informed consent is required from adult participants. Country-specific adult subject information and informed consent forms are provided (documents listed for DE and AT). Participants must be capable of understanding and complying (explicitly requires sufficient knowledge of German to answer questionnaires). No assent or parental consent procedures are described.

Methods

  • Site-based recruitment via participating hospitals/clinics listed in Germany and Austria (site contact details available in trial record).
  • Recruitment materials and arrangements documented (K1 recruitment arrangements) and study flyers listed in trial documents.

Geography

Total Number Of Sites
9
Total Number Of Participants
5000

Germany

Earliest CTIS Part Ii Submission Date
19-06-2024
Latest Decision Or Authorization Date
20-01-2026
Processing Time Days
580
Number Of Sites
7
Number Of Participants
4000

Sites

Site Name
GPR Gesundheits und Pflegezentrum Ruesselsheim gGmbH
Department Name
Klinik für Orthopädie
Contact Person Name
Manfred Krieger
Contact Person Email
krieger@gp-ruesselsheim.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Zentrum für Orthopädie und Unfallchirurgie
Contact Person Name
Philipp Drees
Site Name
Technische Universitaet Dresden
Department Name
University Center of Orthopedics, Trauma and Plastic Surgery (OUPC)
Contact Person Name
Maik Stiehler
Contact Person Email
Maik.stiehler@ukdd.de
Site Name
University Of Luebeck
Department Name
Klinik für Orthopädie und Unfallchirurgie
Contact Person Name
Andreas, Christoph Unger
Contact Person Email
Andreas.Unger@uksh.de
Site Name
Sana Kliniken Berlin-Brandenburg GmbH
Department Name
Klinik für Operative Orthopädie
Contact Person Name
Andreas Halder
Contact Person Email
Andreas.Halder@sana-hu.de
Site Name
Evangelisches Waldkrankenhaus Spandau Krankenhausbetriebs gGmbH
Department Name
Orthopädie und Unfallchirurgie
Contact Person Name
Ulrich Nöth
Contact Person Email
Ulrich.Noeth@jsd.de
Site Name
BG Klinikum Hamburg gGmbH
Department Name
Zentrum für Klinische Forschung
Contact Person Name
Arndt-Peter Schulz
Contact Person Email
A.Schulz@bgk-hamburg.de

Austria

Earliest CTIS Part Ii Submission Date
12-07-2024
Latest Decision Or Authorization Date
21-01-2026
Processing Time Days
558
Number Of Sites
2
Number Of Participants
1000

Sites

Site Name
Johannes Kepler University Linz
Department Name
University Clinic of Orthopaedics and Traumatology
Contact Person Name
Tobias Gotterbarm
Site Name
Orthopaedisches Spital Speising GmbH
Department Name
Orthopaedic hospital Vienna-Speising
Contact Person Name
Jochen Hofstätter
Contact Person Email
Research@oos.at

Sponsor

Primary sponsor

Full Name
Universitaetsmedizin Der Johannes Gutenberg-Universitaet Mainz Koerperschaft Des Offentlichen Rechts
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Germany

Investigational products

Investigational Product Name
Rivaroxaban
Active Substance
RIVAROXABAN
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (marketing authorisation / SmPC available)
Starting Dose
10 mg once daily
Dose Levels
10 mg
Frequency
once daily
Maximum Dose
10 mg once daily
Investigational Product Name
Placebo hard capsules were manufactured from P-tablets (P-Tabletten weiß 7 mm Lichtenstein®, Zulassungs-Nr. 6866372.00.00). For further information see SmPC
Modality
Other

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