Prevention of Venous ThromboembolismPhase 3PRO-LAPSIINCT03055026
Rivaroxaban or Placebo for Extended Antithrombotic Prophylaxis After Laparoscopic Surgery for Colorectal Cancer.
A Phase 3 study testing Rivaroxaban in people with Prevention of Venous Thromboembolism, run by Fadoi Foundation, Italy at 17 sites in Italy.
Trial summary
Rivaroxaban or placebo for extended antithrombotic prophylaxis after laparoscopic surgery for colorectal cancer: a randomized, double blind, placebo-controlled study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prevention of Venous Thromboembolism
- What is being tested?
- Rivaroxaban
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 582 participants
- Where
- 17 sitesItaly
- Study dates
- 3 May 2017to 6 Sep 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Italy17 sites
Ospedale San Donato
Arezzo
Ospedale San Giacomo Apostolo
Castelfranco Veneto, Treviso
Istituto Clinico Humanitas Mater Domini
Castellanza, Varese
Ospedale di Cittadella
Cittadella, Padova
AOU Careggi
Florence
Nuovo Ospedale "San Giovanni Battista"
Foligno
AOU Federico II
Naples
IRCCS Fondazione Pascale
Naples
Policlinico di Padova
Padova
Ospedale Santa Maria della Misericordia
Perugia
Ospedale San Salvatore
Pesaro
Ospedale di Piacenza
Piacenza
Ospedale E. Agnelli
Pinerolo, Torino
Ospedale Santa Maria delle Grazie
Pozzuoli, Napoli
Policlinico Gemelli
Roma
Ospedale San Matteo degli Infermi
Spoleto, Perugia
Ospedale Santa Maria
Terni
About this study
Official title: 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.
- Conditions
- Prevention of Venous Thromboembolism
- Being tested
- Rivaroxaban, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
Tablets
PlaceboDrug
Tablets
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban | Experimental | Orally administered, at the dose of 10 mg OD for 3 weeks (extended prophylaxis) Receives: Drug: Rivaroxaban |
| Placebo | Placebo comparator | Orally administered, OD for 3 weeks (extended prophylaxis) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous thromboembolism
The primary study outcome is a composite of symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT or VTE-related death.
Measured: 28±2 days from planned laparoscopic surgery for colorectal cancer in patients randomized to rivaroxaban or placebo.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start3 May 2017
- Primary completion9 Jul 2021
- Study completion6 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prevention of Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 582 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fadoi Foundation, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- University Of Perugia
- Responsible party
- Sponsor
- Investigators
- Mauro Campanini, Study director, FADOI Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055026
- Sponsor's protocol ID
- FADOI.01.2016
- Acronym
- PRO-LAPSII
- Status last verified
- Feb 2022
- First submitted
- 13 Feb 2017
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 35580191
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rivaroxaban or Placebo for Extended Antithrombotic Prophylaxis After Laparoscopic Surgery for Colorectal Cancer: a Randomized, Double Blind, Placebo-controlled Study.
- ClinicalTrials.gov ID
- NCT03055026
- Acronym / sponsor ID
- PRO-LAPSII / FADOI.01.2016
- Conditions
- Prevention of Venous Thromboembolism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 582 participants (actual)
- Lead sponsor
- Fadoi Foundation, ItalyUniversity, hospital or other
- Collaborators
- University Of Perugia
- Study start
- 3 May 2017 (actual)
- Primary completion
- 9 Jul 2021 (actual)
- Study completion
- 6 Sep 2021 (actual)
- First posted
- 16 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rivaroxaban or placebo for extended antithrombotic prophylaxis after laparoscopic surgery for colorectal cancer: a randomized, double blind, placebo-controlled study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban | Experimental | Drug: RivaroxabanOrally administered, at the dose of 10 mg OD for 3 weeks (extended prophylaxis) |
| Placebo | Placebo comparator | Drug: PlaceboOrally administered, OD for 3 weeks (extended prophylaxis) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- Age < 18 years
- Surgery for non-cancer disease
- Duration of surgery < 45 min
- Conversion to open surgery
- Other indication for anticoagulant therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RivaroxabanTablets | Drug | Rivaroxaban |
| PlaceboTablets | Drug | Placebo |
Primary outcome
Venous thromboembolism
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Derived from this study: PubMed 35580191Becattini 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mauro Campanini study director
FADOI Foundation
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rivaroxaban in people with Prevention of Venous Thromboembolism, run by Fadoi Foundation, Italy at 17 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venous thromboembolism (time frame: 28±2 days from planned laparoscopic surgery for colorectal cancer in patients randomized to rivaroxaban or placebo.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03055026, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.