Innohep® in Elderly Patients With Impaired Renal Function Treated for Acute Deep Vein Thrombosis

LEO Pharma

Status and phase

Completed

Phase 4

Conditions

Deep Vein Thrombosis

Treatments

Drug: Heparin

Drug: innohep®

Study type

Interventional

Funder types

Industry

Identifiers

NCT00277394

IN 0401 INT

Details and patient eligibility

About

The objective of the 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 Venous Thrombosis (DVT).

The primary response criterion is the percentage of patients with clinically relevant bleeding events prior to day 90 +/- 5.

Enrollment

541 patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with a symptomatic and objectively confirmed Venous Thromboembolism (VTE) (lower limb deep venous thrombosis (DVT) or pulmonary embolus (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 hous prior to randomisation)
Patients with an indication for DVT treatment with SC Low Molecular Weight Heparin (LMWH) or Unfractionated Heparin (UFH) followed by Oral Anticoagulant (OAC) for at least 90 days
Hospitalized patients who, during SC anticoagulant treatment, will be followed, as specified in the protocol, on a daily basis either in the hospital or in an out-patient setting
Patients at or above 75 years with a creatinine clearance less than or equal to 60 mL/min calculated according to the Cockcroft-Gault formula
Patients at or above 70 years with a creatinine clearance less than or equal to 30 mL/min calculated according to the Cockcroft-Gault formula

Exclusion criteria

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
Patients on oral anticoagulant treatment (vitamin K-antagonists) at or within last 1 week prior to randomisation
Patients with a symptomatic venous thromboembolism (VTE) requiring thrombolytic therapy or invasive intervention
End stage renal disease patients requiring dialysis
Surgery within 2 weeks prior to randomisation or planned surgery, epidural anaesthesia and/or spinal anaesthesia during the SC anticoagulant treatment period
Planned use of acetylsalicylic acid in doses above 300 mg/day, NSAID or Dextran 40 at randomisation and during the SC anticoagulant treatment period
Patients with a current overt bleeding or known haemorrhage condition (e.g. active G.I. ulcer)
Patients with a platelet count < 100 x 10 9/L
Patients with a known history of heparin-induced thrombocytopenia
Patients with known severe hepatic insufficiency manifested as international normalized ratio (INR) greater than or equal to 1.5
Patients with uncontrolled severe hypertension i.e. a systolic blood pressure > 220 mm Hg or diastolic blood pressure > 120 mm Hg during at least 2 measurements within 24 hours prior to randomisation
Patients with ischaemic stroke at or within last 1 week prior to randomisation
Patients with a known haemorrhagic stroke within 3 months prior to randomisation
Patients with known bacterial endocarditis within 3 months prior to randomisation