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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00277394
Recruitment Status : Completed
First Posted : January 16, 2006
Results First Posted : December 21, 2010
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Deep Vein Thrombosis Drug: innohep® Drug: Heparin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 541 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety Profile of Innohep Versus Subcutaneous Unfractionated Heparin in Elderly Patients With Impaired Renal Function Treated for Acute Deep Vein Thrombosis
Study Start Date : December 2005
Actual Primary Completion Date : May 2008
Actual Study Completion Date : July 2008

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Arms and Interventions
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Arm Intervention/treatment
Experimental: innohep®
innohep® 175 anti-Xa IU/kg once daily
 Drug: innohep®
175 anti-Xa IU/kg administered subcutaneously (SC) once daily
Active Comparator: Heparin
Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
 Drug: Heparin
Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Patients With Clinically Relevant Bleeding Events [ Time Frame: prior to day 90 +/- 5 ]

Secondary Outcome Measures :
  1. Number of Patients With Recurrence of Venous Thromboembolism [ Time Frame: prior to day 90 +/- 5 ]
  2. Number of Patients With Major Bleeding Events [ Time Frame: prior to day 90 +/- 5 ]

Eligibility Criteria
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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00277394


Locations
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Bulgaria
Bulgaria - managed by CRO
Sofia, Bulgaria
Croatia
Croatia - managed by CRO
Zagreb, Croatia
Czechia
Czech Republic - managed by CRO
Praha, Czechia
France
Hôpital de la Cavale Blanche
Brest, France, 29609
Germany
Med. Klinik IV/Klinikum Darmstadt
Darmstadt, Germany, 64297
Poland
Klinika Chirugii Naczyniowej
Szczecin, Poland, 70-111
Romania
Romania - managed by CRO
Bucharest, Romania, 010965
Serbia
Clinical Center Serbia, Institute of Cardiovascular diseases & Centre for Vascular Surgery-Belgrade
Belgrade, Serbia, 11000
Spain
Service of Geriatry, Hospital Universitario Clínico San Carlos
Madrid, Spain, 28040
Sponsors and Collaborators
LEO Pharma
Investigators
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Principal Investigator: Alain Leizorovicz, MD Faculté de Médecine Laënnec
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT00277394    
Other Study ID Numbers: IN 0401 INT
First Posted: January 16, 2006    Key Record Dates
Results First Posted: December 21, 2010
Last Update Posted: March 15, 2019
Last Verified: February 2019
Keywords provided by LEO Pharma:
Acute, symptomatic and objectively confirmed DVT
Additional relevant MeSH terms:
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Tinzaparin
Renal Insufficiency
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
 Kidney Diseases
Urologic Diseases
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action