NCT03055026

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
582

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2017

Typical duration for phase_3

Geographic Reach
1 country

17 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

First Submitted

Initial submission to the registry

February 13, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 16, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

May 3, 2017

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2021

Completed
Last Updated

March 11, 2022

Status Verified

February 1, 2022

Enrollment Period

4.2 years

First QC Date

February 13, 2017

Last Update Submit

March 10, 2022

Conditions

Prevention of Venous Thromboembolism

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Rivaroxaban

EXPERIMENTAL

Orally administered, at the dose of 10 mg OD for 3 weeks (extended prophylaxis)

Drug: Rivaroxaban

Placebo

PLACEBO COMPARATOR

Orally administered, OD for 3 weeks (extended prophylaxis)

Drug: Placebo

Interventions

RivaroxabanDRUG

Tablets

Rivaroxaban
PlaceboDRUG

Tablets

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Ospedale Santa Maria delle Grazie

Pozzuoli, Napoli, Italy

Location

Ospedale di Cittadella

Cittadella, Padova, Italy

Location

Ospedale San Matteo degli Infermi

Spoleto, Perugia, Italy

Location

Ospedale E. Agnelli

Pinerolo, Torino, Italy

Location

Ospedale San Giacomo Apostolo

Castelfranco Veneto, Treviso, Italy

Location

Istituto Clinico Humanitas Mater Domini

Castellanza, Varese, Italy

Location

Ospedale San Donato

Arezzo, Italy

Location

AOU Careggi

Florence, Italy

Location

Nuovo Ospedale "San Giovanni Battista"

Foligno, Italy

Location

AOU Federico II

Napoli, Italy

Location

IRCCS Fondazione Pascale

Napoli, Italy

Location

Policlinico di Padova

Padua, Italy

Location

Ospedale Santa Maria della Misericordia

Perugia, Italy

Location

Ospedale San Salvatore

Pesaro, Italy

Location

Ospedale di Piacenza

Piacenza, Italy

Location

Policlinico Gemelli

Roma, Italy

Location

Ospedale Santa Maria

Terni, Italy

Location

Related Publications (1)

  • 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.

    PMID: 35580191DERIVED

MeSH Terms

Interventions

Rivaroxaban

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Mauro Campanini

    FADOI Foundation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2017

First Posted

February 16, 2017

Study Start

May 3, 2017

Primary Completion

July 9, 2021

Study Completion

September 6, 2021

Last Updated

March 11, 2022

Record last verified: 2022-02

Locations

IT(17)