Absorption of Rivaroxaban in Patients With Cervical Spinal Cord Injury

NCT02970773 | Withdrawn Phase 4

• 1 other identifier: 2013-21
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to investigate the pharmacokinetic and -dynamic properties of rivaroxaban after oral administration in cervical spinal cord injury (SCI) individuals. The secondary objective of this study is to determine the steady-state rivaroxaban activity in cervical SCI individuals under long-term therapy. Primary Objective In-house patients will be informed concerning the study and informed consent will be collected. During the screening day, in- / exclusion criteria will be assessed and a blood samples will be taken for assessing haematology, clinical chemistry and coagulation parameters. Furthermore, the evaluation day will be scheduled. On the evaluation day, in- / exclusion criteria will be re-assessed. A venous catheter will be introduced into a forearm or lower leg of each participant for the collection of blood at the specified time points. Skin inspection for subcutaneous bleeding will be performed and vital signs will be recorded. A blood sample will be taken for assessing haematology, clinical chemistry and coagulation parameters. Single administration of oral rivaroxaban in the form of Xarelto® 10mg tablets (Bayer Schering Pharma, Berlin, Germany). Rivaroxaban concentrations will be determined from plasma samples taken before, 30min after and 1, 2, 3, 4, 5, 6, 8, 12, 24 hours after rivaroxaban administration. Rivaroxaban activity will be determined from plasma samples taken before, 30min after and 1, 2, 3, 4, 5, 6, 8, 12, 24 hours after rivaroxaban administration using a factor Xa inhibition test and measuring prothrombin time (PT) and activated partial thromboplastin time (aPTT). Skin inspection for subcutaneous bleeding and measurements of vital signs will be performed 30min and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours after rivaroxaban administration. Secondary Objective Patients under long-term rivaroxaban therapy will be recruited during their annual check-up visit at the Swiss Paraplegic Centre. In- / exclusion criteria will be assessed, and the patients will be informed concerning the study and informed consent will be collected. Blood samples will be taken for assessing haematology, clinical chemistry and coagulation parameters, and skin inspection for subcutaneous bleeding and measurements of vital signs will be performed. A blood sample (4.3ml citrated venous blood) will be taken for assessing the primary and secondary outcome parameters.

Conditions

Spinal Cord Injuries; Thromboembolism

Outcome Measures

Primary Outcomes (1)

• rivaroxaban plasma level

  before drug administration and 30min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 12h and 24h after drug administration

Secondary Outcomes (2)

• inhibition of factor XII

  before drug administration and 30min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 12h and 24h after drug administration

• prothrombin time

  before drug administration and 30min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 12h and 24h after drug administration

Study Arms (1)

rivaroxaban

OTHER

Rivaroxaban Oral Tablet

Drug: Rivaroxaban Oral Tablet

Interventions

Rivaroxaban Oral Tablet DRUG

oral application of Xarelto

rivaroxaban

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Motor complete tetraplegia for at least 3 months
• Age from 18 to 74 years
• Body mass index (BMI) from 18 to 35kg/m2
• Informed consent as documented by signature

You may not qualify if:

• Any anti-coagulation therapy (apart from rivaroxaban for second objective)
• Hypersensitivity or allergy to factor Xa inhibitors
• Acute bacterial endocarditis
• Bleeding disorder
• Clinically relevant active bleeding
• Gastrointestinal ulcer or tumor
• Hepatic dysfunction with increased bleeding risk
• Renal failure / patients undergoing dialysis
• Pregnancy and breast feeding
• Gastrectomy, biliopancreatic diversion, resection or re-routing of small intestines
• Feeding tube
• Recent blood donation
• Abnormalities of laboratory values: alanine-aminotransferase (ALAT), aspartate-aminotransferase (ASAT), gamma-glutamyl transferase (gammaGT), alkalic phosphatase (AP), bilirubin, amylase, lipase, cystatin C, creatinine, white blood cell count, haemoglobin, platelet count, prothrombin time, aPTT, fibrinogen, thrombin time, factors II,V,VII and X
• Use of therapeutic or recreational drugs influencing plasmatic coagulation

Sponsors & Collaborators

• Swiss Paraplegic Research, Nottwil: lead

Study Sites (1)

Swiss Paraplegic Centre Nottwil

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Thromboembolism

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Peter Felleiter, MD PhD

  Swiss Parapelgic Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2016
• First Posted: November 22, 2016
• Study Start: December 4, 2017
• Primary Completion: December 7, 2018
• Study Completion: December 7, 2018
• Last Updated: January 22, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)