NCT03055026 (PRO-LAPSII) is a Phase 3 clinical trial of Rivaroxaban in Prevention of Venous Thromboembolism, sponsored by Fadoi Foundation, Italy.

Who is sponsoring NCT03055026?

NCT03055026 is sponsored by Fadoi Foundation, Italy.

What drugs are being tested in NCT03055026?

Interventions in NCT03055026: Rivaroxaban, Placebo.

What condition does NCT03055026 study?

NCT03055026 studies Prevention of Venous Thromboembolism.

Is NCT03055026 still recruiting?

NCT03055026 is currently completed. Last updated 11 March 2022.

Last reviewed 2022-03-11 · How we verify

NCT03055026: PRO-LAPSII

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Last updated 11 March 2022

What this trial tests

Phase 3 trial testing Rivaroxaban in Prevention of Venous Thromboembolism in 582 participants. Completed in 6 September 2021.

Timeline

3 May 2017

Primary endpoint
9 July 2021

6 September 2021

Quick facts

Lead sponsor	Fadoi Foundation, Italy
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	582
Start date	3 May 2017
Primary completion	9 July 2021
Estimated completion	6 September 2021
Sites	17 locations across Italy

Drugs / interventions tested

Rivaroxaban (rivaroxaban) — full drug profile →
Placebo

Conditions studied

Prevention of Venous Thromboembolism — all drugs for Prevention of Venous Thromboembolism →

Sponsor

Fadoi Foundation, Italy

Who can join

18 and older, any sex, with Prevention of Venous Thromboembolism. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Rivaroxaban vs placebo for extended antithrombotic prophylaxis after laparoscopic surgery for colorectal cancer.
Becattini C, Pace U, Pirozzi F, Donini A, et al · · 2022 · cited 50× · PMID 35580191 · DOI 10.1182/blood.2022015796
COSIMO - patients with active cancer changing to rivaroxaban for the treatment and prevention of recurrent venous thromboembolism: a non-interventional study.
Cohen AT, Maraveyas A, Beyer-Westendorf J, Lee AYY, et al · · 2018 · cited 16× · PMID 30186045 · DOI 10.1186/s12959-018-0176-2
Cancer-associated venous thromboembolism: Treatment and prevention with rivaroxaban.
Bauersachs R, Khorana AA, Lee AYY, Soff G. · · 2020 · cited 7× · PMID 32548552 · DOI 10.1002/rth2.12327
Rivaroxaban for extended antithrombotic prophylaxis after laparoscopic surgery for colorectal cancer. Design of the PRO-LAPS II STUDY.
Becattini C, Pace U, Rondelli F, Delrio P, et al · · 2020 · cited 6× · PMID 31818628 · DOI 10.1016/j.ejim.2019.11.015
Direct Oral Anticoagulants and Cancer-Associated Thrombosis Management. Where Do We Stand in 2019?
Ramacciotti E, Agati LB, Caffaro RA, Volpiani GG, et al · · 2019 · cited 2× · PMID 31234637 · DOI 10.1177/1076029619856433
Oral Communication abstracts
· 2022

Verify or expand the search:

Other trials of Rivaroxaban

Trials testing the same drug.

NCT06953726 — Comparing the Safety and Efficacy of Apixaban and Rivaroxaban · Phase 4 · not yet recruiting
NCT07468448 — Combination Antithrombotic Treatment for Prevention of Recurrent Ischemic Stroke in IntraCranial Atherosclerotic diseaSe · Phase 3 · not yet recruiting
NCT07318610 — Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease · Phase 3 · not yet recruiting
NCT07312851 — A Study to Investigate Andexanet Dosing and the Interaction Between Andexanet and Subsequent Enoxaparin in Healthy Parti · Phase 1 · recruiting
NCT06961630 — Post-Operative Biomarker-Guided Precision Medicine For Cardiovascular Risk Reduction · EARLY_PHASE1 · recruiting

Other recruiting trials for Prevention of Venous Thromboembolism

Currently open trials in the same condition.

NCT06193863 — An Observational Study to Learn More About How Safe Rivaroxaban is And How Well it Works in Children With Congenital Hea · active not recruiting

Other Fadoi Foundation, Italy trials

Trials by the same sponsor.

NCT05239988 — Observational Study in COVID-19 Patients Treated With Remdesivir · completed
NCT05247931 — Why Does Aspirin Fail in Secondary Cerebrovascular Prevention? A Multicenter Prospective Case - Control Study · unknown
NCT04257422 — Intentional Rounding in Internal Medicine · NA · terminated
NCT06293768 — Continuous Wireless Monitoring for Patients in the Internal Medicine UOC. Randomized Controlled Trial (GreenLineH-T) · NA · completed
NCT04589533 — MANAGEMENT OF PATIENTS WITH TYPE 2 DIABETES MELLITUS HOSPITALIZED IN INTERNAL MEDICINE UNITS (MINDER Study) · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03055026 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fadoi Foundation, Italy
Last refreshed: 11 March 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03055026.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing