NCT00277394

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
541

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2005

Typical duration for phase_4

Geographic Reach
9 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 13, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 16, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

December 21, 2010

Completed
Last Updated

March 6, 2025

Status Verified

February 1, 2019

Enrollment Period

2.4 years

First QC Date

January 13, 2006

Results QC Date

November 23, 2010

Last Update Submit

February 21, 2025

Conditions

Deep Vein Thrombosis

Keywords

Acute, symptomatic and objectively confirmed DVT

Outcome Measures

Primary Outcomes (1)

  • Number of Patients With Clinically Relevant Bleeding Events

    prior to day 90 +/- 5

Secondary Outcomes (2)

  • Number of Patients With Recurrence of Venous Thromboembolism

    prior to day 90 +/- 5

  • Number of Patients With Major Bleeding Events

    prior to day 90 +/- 5

Study Arms (2)

innohep®

EXPERIMENTAL

innohep® 175 anti-Xa IU/kg once daily

Drug: innohep®

Heparin

ACTIVE COMPARATOR

Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.

Drug: Heparin

Interventions

innohep®DRUG

175 anti-Xa IU/kg administered subcutaneously (SC) once daily

innohep®
HeparinDRUG

Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.

Heparin

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Bulgaria - managed by CRO

Sofia, Bulgaria

Location

Croatia - managed by CRO

Zagreb, Croatia

Location

Czech Republic - managed by CRO

Prague, Czechia

Location

Hôpital de la Cavale Blanche

Brest, 29609, France

Location

Med. Klinik IV/Klinikum Darmstadt

Darmstadt, 64297, Germany

Location

Klinika Chirugii Naczyniowej

Szczecin, 70-111, Poland

Location

Romania - managed by CRO

Bucharest, 010965, Romania

Location

Clinical Center Serbia, Institute of Cardiovascular diseases & Centre for Vascular Surgery-Belgrade

Belgrade, 11000, Serbia

Location

Service of Geriatry, Hospital Universitario Clínico San Carlos

Madrid, 28040, Spain

Location

Related Publications (1)

  • Leizorovicz A, Siguret V, Mottier D; Innohep(R) in Renal Insufficiency Study Steering Committee; Leizorovicz A, Siguret V, Mottier D, Clonier F, Janas M, Stinson J, Townshend G, Maddalena M. Safety profile of tinzaparin versus subcutaneous unfractionated heparin in elderly patients with impaired renal function treated for acute deep vein thrombosis: the Innohep(R) in Renal Insufficiency Study (IRIS). Thromb Res. 2011 Jul;128(1):27-34. doi: 10.1016/j.thromres.2011.03.002. Epub 2011 Apr 7.

    PMID: 21477846DERIVED

Related Links

MeSH Terms

Conditions

Venous Thrombosis

Interventions

TinzaparinHeparin

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightGlycosaminoglycansPolysaccharidesCarbohydrates

Results Point of Contact

Title
Torsten Skov, Senior Medical Advisor
Organization
Leo Pharma
tosdk@leo-pharma.com
+45 72263990

Study Officials

  • Alain Leizorovicz, MD

    Faculté de Médecine Laënnec

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2006

First Posted

January 16, 2006

Study Start

December 1, 2005

Primary Completion

May 1, 2008

Study Completion

July 1, 2008

Last Updated

March 6, 2025

Results First Posted

December 21, 2010

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)PL(1)RO(1)BU(1)FR(1)SE(1)CR(1)DE(1)ES(1)