Clinical trial • Phase III • Cardiology

SULODEXIDE for Venous thromboembolism (deep vein thrombosis and pulmonary embolism) | Deep vein thrombosis | Pulmonary embolism

Phase III trial of SULODEXIDE for Venous thromboembolism (deep vein thrombosis and pulmonary embolism) | Deep vein thrombosis | Pulmonary embolism.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Venous thromboembolism (deep vein thrombosis and pulmonary embolism) | Deep vein thrombosis | Pulmonary embolism
Trial Stage
Phase III
Drug Modality
Other

Key dates

Initial CTIS Submission Date
11-10-2024
First CTIS Authorization Date
12-11-2024

Trial design

Randomised, arm a: sulodexide (vessel®), 2 capsules of 250 lsu bid for 12 months; arm b: sulodexide (vessel®), 1 capsule of 250 lsu and 1 capsule placebo bid for 12 months; arm c: 2 indistinguishable placebo capsules bid for 12 months-controlled Phase III trial in Italy.

Randomised
Yes
Comparator
Arm A: Sulodexide (VESSEL®), 2 capsules of 250 LSU BID for 12 months; Arm B: Sulodexide (VESSEL®), 1 capsule of 250 LSU and 1 capsule placebo BID for 12 months; Arm C: 2 indistinguishable placebo capsules BID for 12 months
Target Sample Size
1455
Trial Duration For Participant
365

Eligibility

Recruits 1455 No vulnerable populations selected; only patients capable and able to provide informed consent are eligible; patients incapacitated or refusing to sign the informed consent are excluded..

Vulnerable Population
No vulnerable populations selected; only patients capable and able to provide informed consent are eligible; patients incapacitated or refusing to sign the informed consent are excluded.

Inclusion criteria

  • {"criterion_text":"-Patients with a first event of proximal lower extremity DVT and / or PE,"}
  • {"criterion_text":"-Patients aged =>75 years at the time of enrolment"}
  • {"criterion_text":"-Pazienti with at least one of the known risk factors of bleeding (APPENDIX 1): a.- Hypertension - Previous non-minor bleeding event - Renal failure (< 60 ml/min) - Thrombocytopenia (<100,000 mm3) - Diabetes - Ongoing ASA therapy (maximum 140 mg/day) - Frequent falls (>2 per year) - Use of non-steroidal anti-inflammatory drugs - Liver failure (transaminases > 3 times the upper reference limit) - Previous cerebral stroke - Anemia (hemoglobin< 100 g/L) - Insufficient control of anticoagulant therapy (TTR: Time in range < 60%) - Alcohol abuse"}
  • {"criterion_text":"-Patients of both sexes."}
  • {"criterion_text":"-Patients who at the time of enrolment have already undergone a period of anticoagulant therapy (AT, with any medication) of at least 3 months and the therapy has not been suspended for more than 30 days."}
  • {"criterion_text":"-Patients with no other AT indications."}
  • {"criterion_text":"-Patients capable and able to provide informed consent."}

Exclusion criteria

  • {"criterion_text":"-Patients aged <75 years at the time of the recruitment visit."}
  • {"criterion_text":"-Presence of other clinical conditions requiring anticoagulant therapy."}
  • {"criterion_text":"-Presence of Inferior vena cava (IVC) filter."}
  • {"criterion_text":"-Patients in therapy with antiplatelet medicinal products other than ASA. The ASA is allowed up to 140 mg / day."}
  • {"criterion_text":"-All clinical conditions requiring long-term treatment with low molecular weight heparin (LMWH)."}
  • {"criterion_text":"-Presence of Antiphospholipid Antibody Syndrome (according to Sydney criteria)"}
  • {"criterion_text":"-Known carriers of one or more of the following thrombophilic alterations: deficiency of physiological anticoagulants (antithrombin, protein C, protein S)."}
  • {"criterion_text":"-Presence of inflammatory bowel disease in acute;"}
  • {"criterion_text":"-Cardiorespiratory failure (New York Heart Association class 3 or 4)."}
  • {"criterion_text":"-Patients incapacitated or refusing to sign the informed consent."}
  • {"criterion_text":"-Patients with life expectancy under 1 year."}
  • {"criterion_text":"-Active cancer."}
  • {"criterion_text":"-Patients residing in a disadvantaged geographical area."}
  • {"criterion_text":"-Patient already enrolled in other clinical trials."}
  • {"criterion_text":"-Pazienti con pressione polmonare sistolica > 40 mm Hg (limite superiore previsto per anziani)."}
  • {"criterion_text":"-Contraindication to Sulodexide (VESSEL®) and Placebo"}
  • {"criterion_text":"-Index event represented by severe PE, with life threatening risk or which involved thrombolytic therapy."}
  • {"criterion_text":"-Index event represented by isolated distal DVT or superficial venous thrombosis."}
  • {"criterion_text":"-Thrombotic event that involved sites other than the deep proximal veins of the lower limbs."}
  • {"criterion_text":"-Anticoagulant therapy in progress for less than 3 months at the time of enrolment."}
  • {"criterion_text":"-Discontinuation of anticoagulant therapy for over three months"}
  • {"criterion_text":"-Recurrent episodes of DVT ± PE (do not consider previous superficial venous thrombosis or isolated distal venous thrombosis as an exclusion criteria);"}
  • {"criterion_text":"-Presence of severe post-thrombotic syndrome (Villalta score >15 or presence ofvenous ulcer)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"-Primary efficacy endpoint: -cumulative result of: new episodes of venous thromboembolism (proximal DVT and / or PE), overall mortality due to VTE","definition_or_measurement_approach":"Cumulative result of new episodes of venous thromboembolism (proximal DVT and/or PE) and overall mortality due to VTE."}
  • {"endpoint_text":"-Primary safety endpoint: - incidence of major bleeding (MB), International Society on Thrombosis and Haemostasis [ISTH] criteria","definition_or_measurement_approach":"Incidence of major bleeding (MB) assessed using ISTH criteria."}

Secondary endpoints

  • {"endpoint_text":"-Secondary efficacy endpoint: Superficial venin thrombosis; Isolated distal deep vein thrombosis;, Cardiovascular events that involved hospitalization; Death from cardiovascular events (myocardial infarction, ischemic stroke).","definition_or_measurement_approach":"Includes events: superficial venous thrombosis; isolated distal DVT; cardiovascular events requiring hospitalization; death from cardiovascular events (MI, ischemic stroke)."}
  • {"endpoint_text":"-Secondary safety endpoint: Cumulative incidence of MB and non-major but clinically relevant haemorrhages [NMCRB]","definition_or_measurement_approach":"Cumulative incidence of major bleeding (MB) and non-major but clinically relevant haemorrhages (NMCRB)."}

Recruitment

Planned Sample Size
1455
Recruitment Window Months
73
Consent Approach
Informed consent must be provided by the participant. Inclusion criterion: "Patients capable and able to provide informed consent." Exclusion: "Patients incapacitated or refusing to sign the informed consent." Subject information and informed consent form documents are available (example: "L1_SIS and ICF adults_IT Italian"); primary available language indicated is Italian.

Geography

Total Number Of Sites
33
Total Number Of Participants
1455

Italy

Earliest CTIS Part Ii Submission Date
28-10-2024
Latest Decision Or Authorization Date
12-11-2024
Processing Time Days
15
Number Of Sites
33
Number Of Participants
1455

Sites

Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
UOC Angiologia
Principal Investigator Name
Sergio De Marchi
Principal Investigator Email
sergio.demarchi@univr.it
Contact Person Name
Sergio De Marchi
Contact Person Email
sergio.demarchi@univr.it
Site Name
AULSS 5 POLESANA, PRESIDIO OSPEDALIERO DI ROVIGO
Department Name
UOS Angiologia
Principal Investigator Name
Marco Marzolo
Principal Investigator Email
marco.marzolo@aulss5.veneto.it
Contact Person Name
Marco Marzolo
Contact Person Email
marco.marzolo@aulss5.veneto.it
Site Name
Ente Ospedaliero Ospedali Galliera Di Genova
Department Name
S.C. Laboratorio di analisi
Principal Investigator Name
Rita Duce
Principal Investigator Email
rita.duce@galliera.it
Contact Person Name
Rita Duce
Contact Person Email
rita.duce@galliera.it
Site Name
Alessandro Manzoni Hospital
Department Name
U.O.S Emostasi e Trombosi
Principal Investigator Name
Valeria De Micheli
Principal Investigator Email
v.demicheli@asst-lecco.it
Contact Person Name
Valeria De Micheli
Contact Person Email
v.demicheli@asst-lecco.it
Site Name
Azienda Ospedaliera di Padova
Department Name
Clinica medica I
Principal Investigator Name
Maria Teresa Sartori
Principal Investigator Email
mtsart@unipd.it
Contact Person Name
Maria Teresa Sartori
Contact Person Email
mtsart@unipd.it
Site Name
Azienda Ospedaliera di Padova
Department Name
UOSD Malattie Trombotiche ed Emorragiche
Principal Investigator Name
Paolo Simioni
Principal Investigator Email
paolo.simioni@unipd.it
Contact Person Name
Paolo Simioni
Contact Person Email
paolo.simioni@unipd.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
UO Pneumologia
Principal Investigator Name
ROberta Pancani
Principal Investigator Email
frapanca@tin.it
Contact Person Name
ROberta Pancani
Contact Person Email
frapanca@tin.it
Site Name
Careggi University Hospital
Department Name
SOD malattie aterotrombotiche
Principal Investigator Name
Daniela Poli
Principal Investigator Email
polida@aou-careggi.toscana.it
Contact Person Name
Daniela Poli
Contact Person Email
polida@aou-careggi.toscana.it
Site Name
AOU Ospedali Riuniti Umberto I°-Lancisi-Salesi di Ancona
Department Name
SOD Clinica Emotologica
Principal Investigator Name
Serena Rupoli
Principal Investigator Email
serena.rupoli@ospedaliriuniti.marche.it
Contact Person Name
Serena Rupoli
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
UOC Angiologia e Malattie della Coagulazione
Principal Investigator Name
Benilde Cosmi
Principal Investigator Email
benilde.cosmi@unibo.it
Contact Person Name
Benilde Cosmi
Contact Person Email
benilde.cosmi@unibo.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
Sezione Ematologia
Principal Investigator Name
Antonio Chistolini
Principal Investigator Email
antonio.chistolini@uniroma1.it
Contact Person Name
Antonio Chistolini
Contact Person Email
antonio.chistolini@uniroma1.it
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Centro trombosi Estense - Medicina interna d'urgenza
Principal Investigator Name
Francesca Lami
Principal Investigator Email
francesca.lami2@aou.mo.it
Contact Person Name
Francesca Lami
Contact Person Email
francesca.lami2@aou.mo.it
Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
S.C. Medicina Cardiovascolare
Principal Investigator Name
Matteo Iotti
Principal Investigator Email
matteo.iotti@ausl.re.it
Contact Person Name
Matteo Iotti
Contact Person Email
matteo.iotti@ausl.re.it
Site Name
Azienda Ospedaliero-Universitaria Pisana
Department Name
U.O Laboratorio Analisi Chimico Cliniche
Principal Investigator Name
Paolo Chiarugi
Principal Investigator Email
p.chiarugi@ao-pisa.toscana.it
Contact Person Name
Paolo Chiarugi
Contact Person Email
p.chiarugi@ao-pisa.toscana.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
UOC Di Medicina Interna e Prevenzione Dell’Aterosclerosi
Principal Investigator Name
Pasquale Pignatelli
Principal Investigator Email
pasquale.pignatelli@uniroma1.it
Contact Person Name
Pasquale Pignatelli
Site Name
Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo
Department Name
Medicina 3
Principal Investigator Name
GianMarco Podda
Principal Investigator Email
gianmarco.podda@asst-santipaolocarlo.it
Contact Person Name
GianMarco Podda
Site Name
Azienda Ulss 3 Serenissima
Department Name
UOSD Ipertensione e Patologie endocrine metaboliche angiologiche
Principal Investigator Name
Roberto Parisi
Principal Investigator Email
roberto.parisi@aulss3.veneto.it
Contact Person Name
Roberto Parisi
Site Name
Azienda Unita Locale Socio Sanitaria N 8 Berica
Department Name
UOC ematologia
Principal Investigator Name
Giuseppe Carli
Principal Investigator Email
g.carli@aulss8.veneto.it
Contact Person Name
Giuseppe Carli
Contact Person Email
g.carli@aulss8.veneto.it
Site Name
AOU Ospedali Riuniti Umberto I°-Lancisi-Salesi di Ancona
Department Name
SOSD medicina Vascolare
Principal Investigator Name
Oriana Zingaretti
Contact Person Name
Oriana Zingaretti
Site Name
Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana
Department Name
UOC Angiologia
Principal Investigator Name
Beniamino Zalunardo
Principal Investigator Email
beniamino.zalunardo@aulss2.veneto.it
Contact Person Name
Beniamino Zalunardo
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
UOC Medicina interna e emocoagulazione
Principal Investigator Name
Antonella Tufano
Principal Investigator Email
atufano@unina.it
Contact Person Name
Antonella Tufano
Contact Person Email
atufano@unina.it
Site Name
Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana
Department Name
UOSD Angiologia
Principal Investigator Name
Nello Zanatta
Principal Investigator Email
nello.zanatta@aulss2.veneto.it
Contact Person Name
Nello Zanatta
Contact Person Email
nello.zanatta@aulss2.veneto.it
Site Name
Azienda Socio Sanitaria Territoriale Di Cremona
Department Name
UUOO Laboratorio analisi chimico cliniche emicrobiologiche
Principal Investigator Name
Sophie Testa
Principal Investigator Email
s.testa@asst-cremona.it
Contact Person Name
Sophie Testa
Contact Person Email
s.testa@asst-cremona.it
Site Name
Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana
Department Name
Medicina 1
Principal Investigator Name
Sabina Villalta
Principal Investigator Email
sabina.villalta@aulss2.veneto.it
Contact Person Name
Sabina Villalta
Site Name
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name
UOC Emostasi
Principal Investigator Name
Rossella Cacciola
Principal Investigator Email
rcacciola@unict.t
Contact Person Name
Rossella Cacciola
Contact Person Email
rcacciola@unict.t
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
UO medicina interna
Principal Investigator Name
Luca Bucherini
Principal Investigator Email
luca.bucherini@auslromagna.it
Contact Person Name
Luca Bucherini
Contact Person Email
luca.bucherini@auslromagna.it
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
Divisione immunologia e medicina trasfusionale
Principal Investigator Name
Luca Barcella
Principal Investigator Email
lbarcella@asst-pg23.it
Contact Person Name
Luca Barcella
Contact Person Email
lbarcella@asst-pg23.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
S.C. Ematologia
Principal Investigator Name
Alessandra Borchiellini
Principal Investigator Email
aborchiellini@cittadellasalute.to.it
Contact Person Name
Alessandra Borchiellini
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
centro emofilia e trombosi
Principal Investigator Name
Paolo Bucciarelli
Principal Investigator Email
paolo.bucciarelli@policlinico.mi.it
Contact Person Name
Paolo Bucciarelli
Site Name
Humanitas Mirasole S.p.A.
Department Name
Centro trombosi e malattie emorragiche
Principal Investigator Name
Corrado Lodigiani
Principal Investigator Email
corrado.lodigiani@humanitas.it
Contact Person Name
Corrado Lodigiani
Contact Person Email
corrado.lodigiani@humanitas.it
Site Name
Azienda Socio Sanitaria Territoriale Della Valtellina E Dell Alto Lario
Department Name
U.O. medicina Generale
Principal Investigator Name
Vittorio Fregoni
Principal Investigator Email
vittorio.fregoni@asst-val.it
Contact Person Name
Vittorio Fregoni
Contact Person Email
vittorio.fregoni@asst-val.it
Site Name
Azienda Unita Sanitaria Locale Di Bologna
Department Name
Programma Ecografia
Principal Investigator Name
Giovanna Elmi
Principal Investigator Email
giovanna.elmi@ausl.bologna.it
Contact Person Name
Giovanna Elmi
Contact Person Email
giovanna.elmi@ausl.bologna.it
Site Name
Ospedale di Vaio Fidenza Azienda USL di Parma
Department Name
UO medicina interna
Principal Investigator Name
Maurizio Ziliotti
Principal Investigator Email
mziliotti@ausl.pr.it
Contact Person Name
Maurizio Ziliotti
Contact Person Email
mziliotti@ausl.pr.it

Sponsor

Primary sponsor

Full Name
Fondazione Arianna Anticoagulazione
Organisation Type
Patient organisation/association
Country Of Registered Address
Italy

Third parties

  • {"country":"","full_name":"ALFASIGMA SpA","duties_or_roles":"Source of monetary support","organisation_type":""}

Investigational products

Investigational Product Name
VESSEL® 250 ULS capsule molli
Active Substance
SULODEXIDE
Modality
Other
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
Authorised
Starting Dose
Arm B: 1 capsule of 250 LSU BID (active 250 LSU per dose); Arm A: 2 capsules of 250 LSU BID (active 500 LSU per dose)
Dose Levels
1 capsule of 250 LSU BID; 2 capsules of 250 LSU BID
Frequency
BID for 12 months
Maximum Dose
1000 U unit(s) per day
Investigational Product Name
The placebo product consists of a soft capsule similar to the ones containing the active substance
Modality
Other
Frequency
2 indistinguishable placebo capsules BID for 12 months

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