Clinical trial · Interventional
Atorvastatin ± Aspirin in Lynch Syndrome Syndrome
Impact of Atorvastatin ± Aspirin on Colorectal Biomarkers in Patients With Lynch Syndrome: a Pilot Study
NCT04379999CI-TRIAL-00093233completedEarly Phase 1ClinicalTrials.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)
The goal of this study is to investigate that a common cholesterol lowering agent (atorvastatin) alone or combining with a nonsteroidal anti-inflammatory drug (aspirin) would reduce the risk of colorectal cancer (CRC) in high-risk individuals with Lynch syndrome.
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 |
|---|---|---|---|
| Lynch Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atorvastatin 20mg | Drug | — | UNRESOLVED |
| Atorvastatin 20mg AND Aspirin 325 mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Atorvastatin
- description
- Atorvastatin (LIPITOR) 20 milligram tablet daily for 6 weeks
- interventionNames
- Drug: Atorvastatin 20mg
- type
- ACTIVE_COMPARATOR
- label
- Atorvastatin and Aspirin
- description
- Atorvastatin (LIPITOR) 20 milligram tablet and Aspirin 325 mg tablet daily for 6 weeks
- interventionNames
- Drug: Atorvastatin 20mg AND Aspirin 325 mg
Primary outcomes (2)
- measure
- Proliferation (Ki-67) and apoptosis (active caspase 3) by immunohistochemical staining
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects who are 18 years of age or older * Able to read and sign an informed consent document in English * Eligible subjects will have molecular evidence of Lynch Syndrome (mutation in MLH1, MSH2, MSH6, EPCAM or PMS2) * History of colorectal cancer if surgically cured and \> 1 year from completion of adjuvant chemotherapy Exclusion Criteria: * Are \<18 years of age * Unable to read and sign an informed consent document in English * Have active cancer or are less than 3 years post hormonal maintenance therapy for cancer * Have statin intolerance or contraindication for aspirin or atorvastatin use * Are pregnant or are actively breast feeding
References
Publications (0)
Data not yet available
No reference posted for this study.