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

Deep Vein Thrombosis Clinical Trial

Official title:

Safety Profile of Innohep Versus Subcutaneous Unfractionated Heparin in Elderly Patients With Impaired Renal Function Treated for Acute Deep Vein Thrombosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00277394
• Other study ID #: IN 0401 INT
• Status: Completed
• Phase: Phase 4
• Start date: December 2005
• Est. completion date: July 2008

Study information

• Verified date: February 2019
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 541
• Est. completion date: July 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Renal Insufficiency
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• innohep®
175 anti-Xa IU/kg administered subcutaneously (SC) once daily
• Heparin
Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.

Locations

Country	Name	City	State
Bulgaria	Bulgaria - managed by CRO	Sofia
Croatia	Croatia - managed by CRO	Zagreb
Czechia	Czech Republic - managed by CRO	Praha
France	Hôpital de la Cavale Blanche	Brest
Germany	Med. Klinik IV/Klinikum Darmstadt	Darmstadt
Poland	Klinika Chirugii Naczyniowej	Szczecin
Romania	Romania - managed by CRO	Bucharest
Serbia	Clinical Center Serbia, Institute of Cardiovascular diseases & Centre for Vascular Surgery-Belgrade	Belgrade
Spain	Service of Geriatry, Hospital Universitario Clínico San Carlos	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Countries where clinical trial is conducted

Bulgaria,  Croatia,  Czechia,  France,  Germany,  Poland,  Romania,  Serbia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Clinically Relevant Bleeding Events		prior to day 90 +/- 5
Secondary	Number of Patients With Recurrence of Venous Thromboembolism		prior to day 90 +/- 5
Secondary	Number of Patients With Major Bleeding Events		prior to day 90 +/- 5

External Links

•   Clinical Trials at LEO Pharma