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

Primary Purpose

Prevention of Venous Thromboembolism

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Rivaroxaban
Placebo
Sponsored by
Fadoi Foundation, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prevention of Venous Thromboembolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ospedale Santa Maria delle Grazie
  • Ospedale di Cittadella
  • Ospedale San Matteo degli Infermi
  • Ospedale E. Agnelli
  • Ospedale San Giacomo Apostolo
  • Istituto Clinico Humanitas Mater Domini
  • Ospedale San Donato
  • AOU Careggi
  • Nuovo Ospedale "San Giovanni Battista"
  • AOU Federico II
  • IRCCS Fondazione Pascale
  • Policlinico di Padova
  • Ospedale Santa Maria della Misericordia
  • Ospedale San Salvatore
  • Ospedale di Piacenza
  • Policlinico Gemelli
  • Ospedale Santa Maria

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rivaroxaban

Placebo

Arm Description

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

Orally administered, OD for 3 weeks (extended prophylaxis)

Outcomes

Primary Outcome Measures

Venous thromboembolism
The primary study outcome is a composite of symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT or VTE-related death.

Secondary Outcome Measures

Full Information

First Posted
February 13, 2017
Last Updated
March 10, 2022
Sponsor
Fadoi Foundation, Italy
Collaborators
University Of Perugia
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1. Study Identification

Unique Protocol Identification Number
NCT03055026
Brief Title
Rivaroxaban or Placebo for Extended Antithrombotic Prophylaxis After Laparoscopic Surgery for Colorectal Cancer.
Acronym
PRO-LAPSII
Official Title
Rivaroxaban or Placebo for Extended Antithrombotic Prophylaxis After Laparoscopic Surgery for Colorectal Cancer: a Randomized, Double Blind, Placebo-controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 3, 2017 (Actual)
Primary Completion Date
July 9, 2021 (Actual)
Study Completion Date
September 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fadoi Foundation, Italy
Collaborators
University Of Perugia

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention of Venous Thromboembolism

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
582 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rivaroxaban
Arm Type
Experimental
Arm Description
Orally administered, at the dose of 10 mg OD for 3 weeks (extended prophylaxis)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Orally administered, OD for 3 weeks (extended prophylaxis)
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban
Intervention Description
Tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets
Primary Outcome Measure Information:
Title
Venous thromboembolism
Description
The primary study outcome is a composite of symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT or VTE-related death.
Time Frame
28±2 days from planned laparoscopic surgery for colorectal cancer in patients randomized to rivaroxaban or placebo.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauro Campanini
Organizational Affiliation
FADOI Foundation
Official's Role
Study Director
Facility Information:
Facility Name
Ospedale Santa Maria delle Grazie
City
Pozzuoli
State/Province
Napoli
Country
Italy
Facility Name
Ospedale di Cittadella
City
Cittadella
State/Province
Padova
Country
Italy
Facility Name
Ospedale San Matteo degli Infermi
City
Spoleto
State/Province
Perugia
Country
Italy
Facility Name
Ospedale E. Agnelli
City
Pinerolo
State/Province
Torino
Country
Italy
Facility Name
Ospedale San Giacomo Apostolo
City
Castelfranco Veneto
State/Province
Treviso
Country
Italy
Facility Name
Istituto Clinico Humanitas Mater Domini
City
Castellanza
State/Province
Varese
Country
Italy
Facility Name
Ospedale San Donato
City
Arezzo
Country
Italy
Facility Name
AOU Careggi
City
Firenze
Country
Italy
Facility Name
Nuovo Ospedale "San Giovanni Battista"
City
Foligno
Country
Italy
Facility Name
AOU Federico II
City
Napoli
Country
Italy
Facility Name
IRCCS Fondazione Pascale
City
Napoli
Country
Italy
Facility Name
Policlinico di Padova
City
Padova
Country
Italy
Facility Name
Ospedale Santa Maria della Misericordia
City
Perugia
Country
Italy
Facility Name
Ospedale San Salvatore
City
Pesaro
Country
Italy
Facility Name
Ospedale di Piacenza
City
Piacenza
Country
Italy
Facility Name
Policlinico Gemelli
City
Roma
Country
Italy
Facility Name
Ospedale Santa Maria
City
Terni
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35580191
Citation
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.
Results Reference
derived

Learn more about this trial

Rivaroxaban or Placebo for Extended Antithrombotic Prophylaxis After Laparoscopic Surgery for Colorectal Cancer.

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