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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03055026
Other study ID # FADOI.01.2016
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date May 3, 2017
Est. completion date September 6, 2021

Study information

Verified date February 2022
Source Fadoi Foundation, Italy
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Rivaroxaban or placebo for extended antithrombotic prophylaxis after laparoscopic surgery for colorectal cancer: a randomized, double blind, placebo-controlled study.


Recruitment information / eligibility

Status Completed
Enrollment 582
Est. completion date September 6, 2021
Est. primary completion date July 9, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Objective diagnosis of colorectal cancer; - Elective laparoscopic surgery for colorectal cancer - Whatever the stage of cancer - Antithrombotic prophylaxis with LMWH administered for 7±2 days after surgery Exclusion Criteria: - Age < 18 years - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Rivaroxaban
Tablets
Placebo
Tablets

Locations

Country Name City State
Italy Ospedale San Donato Arezzo
Italy Ospedale San Giacomo Apostolo Castelfranco Veneto Treviso
Italy Istituto Clinico Humanitas Mater Domini Castellanza Varese
Italy Ospedale di Cittadella Cittadella Padova
Italy AOU Careggi Firenze
Italy Nuovo Ospedale "San Giovanni Battista" Foligno
Italy AOU Federico II Napoli
Italy IRCCS Fondazione Pascale Napoli
Italy Policlinico di Padova Padova
Italy Ospedale Santa Maria della Misericordia Perugia
Italy Ospedale San Salvatore Pesaro
Italy Ospedale di Piacenza Piacenza
Italy Ospedale E. Agnelli Pinerolo Torino
Italy Ospedale Santa Maria delle Grazie Pozzuoli Napoli
Italy Policlinico Gemelli Roma
Italy Ospedale San Matteo degli Infermi Spoleto Perugia
Italy Ospedale Santa Maria Terni

Sponsors (2)

Lead Sponsor Collaborator
Fadoi Foundation, Italy University Of Perugia

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Venous thromboembolism The primary study outcome is a composite of symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT or VTE-related death. 28±2 days from planned laparoscopic surgery for colorectal cancer in patients randomized to rivaroxaban or placebo.
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