Clinical trial · Interventional
Rivaroxaban or Placebo for Extended Antithrombotic Prophylaxis After Laparoscopic Surgery for Colorectal Cancer.
Rivaroxaban or Placebo for Extended Antithrombotic Prophylaxis After Laparoscopic Surgery for Colorectal Cancer: a Randomized, Double Blind, Placebo-controlled Study.
NCT03055026CI-TRIAL-00057043PRO-LAPSIIcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Rivaroxaban or placebo for extended antithrombotic prophylaxis after laparoscopic surgery for colorectal cancer: a randomized, double blind, placebo-controlled study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prevention of Venous Thromboembolism | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Rivaroxaban | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Rivaroxaban
- description
- Orally administered, at the dose of 10 mg OD for 3 weeks (extended prophylaxis)
- interventionNames
- Drug: Rivaroxaban
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Orally administered, OD for 3 weeks (extended prophylaxis)
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Venous thromboembolism
- timeFrame
- 28±2 days from planned laparoscopic surgery for colorectal cancer in patients randomized to rivaroxaban or placebo.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDBecattini 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. PMID 35580191