Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02583191
Other study ID # CONKO-011 AIO-SUP-0115/ass.
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date March 23, 2016
Est. completion date August 19, 2019

Study information

Verified date April 2021
Source AIO-Studien-gGmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to show feasibility (efficacy and safety) of Rivaroxaban in the treatment of VTE in cancer patients in comparison to the standard treatment with low molecular weight heparin (LMWH). Tumor patients with active cancer and newly diagnosed thromboembolic events are randomised to receive either Rivaroxaban or the standard treatment with low-molecular heparin.


Recruitment information / eligibility

Status Terminated
Enrollment 246
Est. completion date August 19, 2019
Est. primary completion date June 11, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Newly diagnosed and objectively confirmed acute venous thromboembolism - Active malignancy - Life expectancy of at least 6 months - Performance-Status according to Karnofsky Performance Scale = 70 % - Patient's compliance and geographical situation allowing an adequate follow up - platelets = 100.000 /µl, INR < 1.5, PTT < 40 sec. - written informed consent of the patient prior to any procedure in connection with the study - male and female patients with an age of at least 18 years Exclusion Criteria: - therapeutic anticoagulation > 96 hours prior to study treatment - known allergic reactions against the study drugs or the substances included therein - known conditions associated with high risk of bleeding, known history of hemorrhagic diathesis - acute clinically relevant bleeding in the last 2 weeks - any history of spontaneous major/cerebral bleeding - history of heparin induced thrombocytopenia II - pregnant or breast-feeding women. Women of child-bearing potential must have a negative pregnancy test performed < 7 days prior to start of the treatment - severe renal insufficiency (GFR < 30 ml/min) - liver disease with coagulation impairment, including Child B and C - cirrhosis - acute medical illness - treatment of the underlying cancer with experimental therapies

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Rivaroxaban
Rivaroxaban 15 mg twice daily for 21 days, followed by 20 mg once daily over a period of 3 months
low-molecular heparine
LMWH in therapeutic dosage (1-2× daily s.c.) according to standards of the individual study center, using licensed dosages, e.g. Enoxaparin 1 mg/kg BW twice daily Tinzaparin 175 I.E./kg BW once daily Dalteparin 200 I.E./kg BW once daily

Locations

Country Name City State
Germany Uniklinik Aachen

Sponsors (3)

Lead Sponsor Collaborator
AIO-Studien-gGmbH Bayer, Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient-reported treatment satisfaction (convenience) with Rivaroxaban in the treatment of acute VTE in cancer patients in comparison with the standard treatment with low molecular weight heparin From randomization to 4 weeks after treatment start
Secondary Rate of symptomatic venous thrombembolism-recurrence within 3 months exploratory analysis for patients with treatment From randomization to 3 months after treatment start
Secondary Exploratory analysis for "time on treatment" From randomization to 12 weeks after treatment start
Secondary Subgroup analysis with regard to rate of Pulmonary embolism, venous thrombembolism recurrence and bleedings (major, clinically relevant, minor) according to stratification characteristics From randomization to end of follow up (up to 24 weeks)
Secondary Rate of myocardial infarction and ischemic stroke From randomization to end of follow up (up to 24 weeks)
Secondary Compliance of patients (adherence) From randomization to end of follow up (up to 24 weeks)
Secondary Overall mortality 3 and 6 months after randomization From randomization to 3 and 6 months after randomization
Secondary Quality of Life (Spitzer Index (Spitzer 1981), Anticlot Treatment Scale (ACTS) and TSQM 4 weekly, up to 12 weeks
Secondary Rate of clinically relevant bleeding (major + clinically relevant non major) within 3 months From randomization to 3 months after randomization
Secondary Rate of minor bleedings within 3 months From randomization to 3 months after randomization
See also
  Status Clinical Trial Phase
Recruiting NCT05346796 - Survivorship Plan HEalth REcord (SPHERE) Implementation Trial N/A
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Completed NCT04867850 - Effect of Behavioral Nudges on Serious Illness Conversation Documentation N/A
Enrolling by invitation NCT04086251 - Remote Electronic Patient Monitoring in Oncology Patients N/A
Completed NCT01285037 - A Study of LY2801653 in Advanced Cancer Phase 1
Completed NCT00680992 - Study of Denosumab in Subjects With Giant Cell Tumor of Bone Phase 2
Completed NCT00062842 - Study of Irinotecan on a Weekly Schedule in Children Phase 1
Active, not recruiting NCT04548063 - Consent Forms in Cancer Research: Examining the Effect of Length on Readability N/A
Completed NCT04337203 - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship N/A
Recruiting NCT04349293 - Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways N/A
Terminated NCT02866851 - Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy N/A
Active, not recruiting NCT05304988 - Development and Validation of the EFT for Adolescents With Cancer
Completed NCT04448041 - CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Completed NCT00340522 - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Completed NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Recruiting NCT06206785 - Resting Energy Expenditure in Palliative Cancer Patients