Absorption of Rivaroxaban in Patients With Cervical Spinal Cord Injury (rivaroxaban)

Swiss Paraplegic Research, Nottwil

Status and phase

Withdrawn

Phase 4

Conditions

Thromboembolism

Spinal Cord Injuries

Treatments

Drug: Rivaroxaban Oral Tablet

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT02970773

2013-21 (Other Identifier)

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 74 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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