Rivaroxaban or Placebo for Extended Antithrombotic Prophylaxis After Laparoscopic Surgery for Colorectal Cancer.
NCT ID: NCT03055026
Last Updated: 2022-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
582 participants
INTERVENTIONAL
2017-05-03
2021-09-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Rivaroxaban
Orally administered, at the dose of 10 mg OD for 3 weeks (extended prophylaxis)
Rivaroxaban
Tablets
Placebo
Orally administered, OD for 3 weeks (extended prophylaxis)
Placebo
Tablets
Interventions
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Rivaroxaban
Tablets
Placebo
Tablets
Eligibility Criteria
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Inclusion Criteria
* Elective laparoscopic surgery for colorectal cancer
* Whatever the stage of cancer
* Antithrombotic prophylaxis with LMWH administered for 7±2 days after surgery
Exclusion Criteria
* Surgery for non-cancer disease
* Duration of surgery \< 45 min
* Conversion to open surgery
* Other indication for anticoagulant therapy
* Known cerebral metastases
* Kidney or liver failure
* Known hemorrhagic diathesis or high risk for bleeding
* History of intracerebral bleeding or neurosurgery within 6 months
* History of heparin induced thrombocytopenia
* Pregnancy or lactation
* Refusal of informed consent.
18 Years
ALL
No
Sponsors
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University Of Perugia
OTHER
Fadoi Foundation, Italy
OTHER
Responsible Party
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Principal Investigators
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Mauro Campanini
Role: STUDY_DIRECTOR
FADOI Foundation
Locations
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Ospedale Santa Maria delle Grazie
Pozzuoli, Napoli, Italy
Ospedale di Cittadella
Cittadella, Padova, Italy
Ospedale San Matteo degli Infermi
Spoleto, Perugia, Italy
Ospedale E. Agnelli
Pinerolo, Torino, Italy
Ospedale San Giacomo Apostolo
Castelfranco Veneto, Treviso, Italy
Istituto Clinico Humanitas Mater Domini
Castellanza, Varese, Italy
Ospedale San Donato
Arezzo, , Italy
AOU Careggi
Florence, , Italy
Nuovo Ospedale "San Giovanni Battista"
Foligno, , Italy
AOU Federico II
Napoli, , Italy
IRCCS Fondazione Pascale
Napoli, , Italy
Policlinico di Padova
Padua, , Italy
Ospedale Santa Maria della Misericordia
Perugia, , Italy
Ospedale San Salvatore
Pesaro, , Italy
Ospedale di Piacenza
Piacenza, , Italy
Policlinico Gemelli
Roma, , Italy
Ospedale Santa Maria
Terni, , Italy
Countries
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References
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Becattini C, Pace U, Pirozzi F, Donini A, Avruscio G, Rondelli F, Boncompagni M, Chiari D, De Prizio M, Visona A, De Luca R, Guerra F, Muratore A, Portale G, Milone M, Castagnoli G, Righini M, Martellucci J, Persiani R, Frasson S, Dentali F, Delrio P, Campanini M, Gussoni G, Vedovati MC, Agnelli G. Rivaroxaban vs placebo for extended antithrombotic prophylaxis after laparoscopic surgery for colorectal cancer. Blood. 2022 Aug 25;140(8):900-908. doi: 10.1182/blood.2022015796.
Other Identifiers
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FADOI.01.2016
Identifier Type: -
Identifier Source: org_study_id
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