Add-Aspirin: A phase III, double-blind, placebo controlled, randomised trial assessing the effects of aspirin on disease recurrence and survival after primary therapy in common non metastatic solid tumours.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511306-23-00

Acronym

AA01

Enrollment

204

Registered

2024-07-01

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer, colon cancer, rectal cancer, stomach cancer, oesophageal cancer, prostate cancer

Brief summary

All participants: Overall survival, Breast cancer participants: Invasive disease-free survival, Colorectal cancer: Disease-free survival, Gastro-oesophageal cancer: Disease-free survival, Prostate cancer: Biochemical recurrence-free survival

Detailed description

Overall survival, Adherence, Toxicity, Serious haemorrhage, Serious vascular events, Thrombotic events, Diabetes and associated complications, Second malignancies, Age-related macular degeneration, Cognitive assessment, Dementia, Functional capacity, Exercise levels, Breast cancer-specific survival, Bone metastases-free survival (breast cancer), IDFS-DCIS (invasive disease-free survival ductal carcinoma in-situ) (breast cancer), Colorectal cancer-specific survival, Prostate cancer-specific survival, Time to initiation of salvage treatment (prostate cancer), Bone metastases-free survival (prostate cancer)

Interventions

DRUGMatching placebo for Aspirin protect 100mg. Pharmaceutical form: Film-coated tablet. Route of administration: Oral use. Major ingredients: Lactose monohydrate 66mg

DRUGCellulose microcrystalline 24mg

DRUGCalcium hydrogen phosphate dihydrate 12mg

DRUGMaize starch 12mg

DRUGMethacrylic acidethylacrylate copolymer 8.1mg

DRUGTalc 8.1mg.

DRUGAspirin® protect 100 mg Magensaftresistente Tablette Acetylsalicylsäure

DRUGMatching placebo for aspirin protect 300mg. pharmaceutical form: film-coated tablet. route of administration: oral use. major ingredients: Lactose monohydrate 198mg

DRUGCellulose microcrystalline 72mg

DRUGCalcium hydrogen phosphate dihydrate 36mg

DRUGMaize starch 36mg

DRUGMethacrylic acidethylacrylate copolymer 22.38mg

DRUGTalc 22.38mg.

DRUGAspirin® protect 300 mg Magensaftresistente Tablette Acetylsalicylsäure

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
All participants: Overall survival, Breast cancer participants: Invasive disease-free survival, Colorectal cancer: Disease-free survival, Gastro-oesophageal cancer: Disease-free survival, Prostate cancer: Biochemical recurrence-free survival	—

Secondary

Measure	Time frame
Overall survival, Adherence, Toxicity, Serious haemorrhage, Serious vascular events, Thrombotic events, Diabetes and associated complications, Second malignancies, Age-related macular degeneration, Cognitive assessment, Dementia, Functional capacity, Exercise levels, Breast cancer-specific survival, Bone metastases-free survival (breast cancer), IDFS-DCIS (invasive disease-free survival ductal carcinoma in-situ) (breast cancer), Colorectal cancer-specific survival, Prostate cancer-specific survival, Time to initiation of salvage treatment (prostate cancer), Bone metastases-free survival (prostate cancer)	—

Measure

Time frame

—

Countries

Ireland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026