Rivaroxaban or Placebo for Extended Antithrombotic Prophylaxis After Laparoscopic Surgery for Colorectal Cancer. (PRO-LAPSII)

Rivaroxaban or Placebo for Extended Antithrombotic Prophylaxis After Laparoscopic Surgery for Colorectal Cancer: a Randomized, Double Blind, Placebo-controlled Study.

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

Study Overview

• Status: Completed
• Conditions: Prevention of Venous Thromboembolism
• Intervention / Treatment: Drug: Placebo; Drug: Rivaroxaban

• Study Type: Interventional
• Enrollment (Actual): 582
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rivaroxaban; Orally administered, at the dose of 10 mg OD for 3 weeks (extended prophylaxis)	Drug: Rivaroxaban; Tablets
Placebo Comparator: Placebo; Orally administered, OD for 3 weeks (extended prophylaxis)	Drug: Placebo; Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Fadoi Foundation, Italy
• Collaborators: University Of Perugia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2017
• Primary Completion (Actual): July 9, 2021
• Study Completion (Actual): September 6, 2021

Study Registration Dates

• First Submitted: February 13, 2017
• First Submitted That Met QC Criteria: February 13, 2017
• First Posted (Actual): February 16, 2017

Study Record Updates

• Last Update Posted (Actual): March 11, 2022
• Last Update Submitted That Met QC Criteria: March 10, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban
• Other Study ID Numbers: FADOI.01.2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No