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

Sponsor

Fadoi Foundation, Italy (Other)

Overall Status

Completed

CT.gov ID

NCT03055026

Collaborator

University Of Perugia (Other)

582

Enrollment

Locations

Arms

52.1

Actual Duration (Months)

34.2

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Prevention of Venous Thromboembolism	Drug: Rivaroxaban Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

582 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

May 3, 2017

Actual Primary Completion Date :

Jul 9, 2021

Actual Study Completion Date :

Sep 6, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Ospedale Santa Maria delle Grazie	Pozzuoli	Napoli	Italy
2	Ospedale di Cittadella	Cittadella	Padova	Italy
3	Ospedale San Matteo degli Infermi	Spoleto	Perugia	Italy
4	Ospedale E. Agnelli	Pinerolo	Torino	Italy
5	Ospedale San Giacomo Apostolo	Castelfranco Veneto	Treviso	Italy
6	Istituto Clinico Humanitas Mater Domini	Castellanza	Varese	Italy
7	Ospedale San Donato	Arezzo		Italy
8	AOU Careggi	Firenze		Italy
9	Nuovo Ospedale "San Giovanni Battista"	Foligno		Italy
10	AOU Federico II	Napoli		Italy
11	IRCCS Fondazione Pascale	Napoli		Italy
12	Policlinico di Padova	Padova		Italy
13	Ospedale Santa Maria della Misericordia	Perugia		Italy
14	Ospedale San Salvatore	Pesaro		Italy
15	Ospedale di Piacenza	Piacenza		Italy
16	Policlinico Gemelli	Roma		Italy
17	Ospedale Santa Maria	Terni		Italy

Sponsors and Collaborators

Fadoi Foundation, Italy
University Of Perugia

Investigators

Study Director: Mauro Campanini, FADOI Foundation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fadoi Foundation, Italy

ClinicalTrials.gov Identifier:

NCT03055026

Other Study ID Numbers:

FADOI.01.2016

First Posted:

Feb 16, 2017

Last Update Posted:

Mar 11, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Thromboembolism

Venous Thromboembolism

Rivaroxaban

Study Results

No Results Posted as of Mar 11, 2022