Treatment of acute deep vein thrombosis in elderly patients with impaired renal function MedDRA version: 6.1 Level: LLT Classification code 10051055
Conditions
Interventions
Trade Name: innohep
Product Name: innohep
Pharmaceutical Form: Injection*
INN or Proposed INN: Tinzaparin Sodium
CAS Number: 9041-08-1
Concentration unit: IU/ml international unit(s)/millilitre
Concen
Sponsors
LEO Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Following receipt of verbal and written information about the trial, the patient must provide signed and dated informed consent before any trial related activity is carried out 2. Patients with a symptomatic and objectively confirmed VTE (lower limb DVT or PE) with mandatory presences of objectively confirmed and treatment requiring DVT, i.e. symptomatic and objectively confirmed distal DVT or objectively confirmed, symptomatic or asymptomatic proximal DVT (confirmation of DVT should be performed by ultrasonography or venography within 48 hours prior to randomisation) 3. Patients with an indication for DVT treatment with SC LMWH or UFH followed by OAC for at least 90 Days 4. Hospitalised patients who, during SC anticoagulant treatment, will be followed, as specified in the protocol, on a daily basis either in hospital or in an out-patient setting 5. Patients at or more than 70 years with a creatinine clearance = 30 mL/min calculated according to the Cockcroft-Gault formula or Patients at or more than 75 years with a creatinine clearance = 60 mL/min calculated according to the Cockcroft-Gault formula 6. Male or female 7. Any ethnic origin Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients receiving high dose (i.e. equivalent to a dose recommended for treatment of DVT) of UFH or LMWH or thrombolytic agents within the last 4 weeks except for UFH/LMWH during the last 36 hours prior to randomisation 2. Patients on oral anticoagulant treatment (vitamin K-antagonists) at or within last 1 week prior to randomisation 3. Patients with a symptomatic VTE requiring thrombolytic therapy or invasive intervention 4. End Stage Renal Disease patients requiring dialysis 5. Surgery within 2 weeks prior to randomisation or planned surgery, epidural anaesthesia and/or spinal anaesthesia during the SC anticoagulant treatment period 6. Planned use of acetylsalicylic acid in doses above 300 mg/day, NSAID or Dextran 40/70 at randomisation and during the SC anticoagulant treatment period 7. Patients with a current overt bleeding or known haemorrhage condition (e.g. active G.I. ulcer) 8. Patients with a platelet count 220 mm Hg or diastolic blood pressure > 120 mm Hg at at least 2 measurements within 24 hours prior to randomisation 12. Patients with ischaemic stroke at or within the last 1 week prior to randomisation 13. Patients with a known haemorrhagic stroke within 3 months prior to randomisation 14. Patients with a known bacterial endocarditis within 3 months prior to randomisation 15. Known or suspected hypersensitivity to component(s) of Investigational Products. 16. Current participation in any other interventional clinical trial 17. Patients who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the last 1 month 18. Patients previously randomised in this trial 19. Patients known or suspected of not being able to comply with the trial protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the safety of innohep and unfractionated heparin (UFH) in terms of Clinically Relevant Bleedings in elderly patients with impaired renal function for initial treatment of acute deep vein thrombosis (DVT). ;Secondary Objective: A secondary objective of this study is to verify that innohep in elderly patients with impaired renal function is effective in terms of prevention of recurrences of venous thromboembolism (VTE). Other secondary and tertiary objectives are to evaluate other safety endpoints under parallel treatment with innohep or unfractionated heparin (UFH) and oral anticoagulants (OAC) and to evaluate interactions between various baseline parameters in relation to secondary and tertiary response criteria.;Primary end point(s): Clinically Relevant Bleedings prior to day 90 +/-5. | — |
Countries
Belgium, Czech Republic, Denmark, Germany, Spain
Outcome results
None listed