Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
744
Countries
1
Sites
5
Pancreatic ductal cancer
To investigate the efficacy and safety of adding antiplatelet theraphy to standard thromboprophylaxis on thrombotic disease in patients with pancreatic ductal cancer.
Key facts
- Sponsor
- Akershus University Hospital
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 21 Aug 2025 → ongoing
- Decision date (initial)
- 2024-08-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Prophylaxis
To investigate the efficacy and safety of adding antiplatelet theraphy to standard thromboprophylaxis on thrombotic disease in patients with pancreatic ductal cancer.
Secondary objectives 1
- To investigate if antiplatelet therapy added to standard thromboprophylaxis improves survival in patients with pancreatic ductal cancer.
Conditions and MedDRA coding
Pancreatic ductal cancer
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | The PANART-trial The PANART-trial is a researcher initiated multicenter, randomized, open label trial comparing standard-of-care thromboprophylaxis with standard-of-care thromboprophylaxis + clopidogrel 75 mg once daily. Thromboprophylaxis will be given as dalteparin 5000 IU once daily. Standard-of-care thromboprophylaxis is defined as how this patient group is treated in daily practice. Daily practice of thromboprophylaxis of pancreatic ductal cancer varies between doctors, departments and hospitals. To avoid starting a prophylactic treatment that is not standard in the control arm, we will let the treating physician select between “on demand thromboprophylaxis” or “always thromboprophylaxis” as standard-of-care prophylactic regime before randomization.
|
Randomised Controlled | None |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Participants are >18 years of age.
- Patients with locally advanced, metastatic or recurrent (after intended therapeutic treatment) pancreatic ductal adenocarcinoma.
- Patients where there is planned treatment or already receive treatment for their pancreatic ductal cancer.
- Patients receiving neoadjuvant chemotherapy before intended curative surgery.
Exclusion criteria 11
- Current use of antiplatelet therapy or disease with indication for antiplatelet therapy not yet initiated.
- Current use of full dose anti-coagulation or disease with indication of full dose anti-coagulation. Patients already on primary prophylaxis can be included.
- Platelets <30×10^9/L.
- Severe intestinal malabsorption.
- Known allergies to study medication.
- Active bleeding or severe risk of bleeding.
- Clinically significant liver disease (e.g., chronic active hepatitis, or cirrhosis).
- Known previous heparin induced thrombocytopenia – HIT
- Known pregnancy (pregnancy test is not necessary)
- Known hypersensitivity to clopidogrel or dalteparin
- Known CYP2C19 genotype that influences clopidogrel metabolism (genotyping not necessary)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Efficacy: A composite of objectively verified arterial or venous thrombosis. Safety: Major bleeding.
Secondary endpoints 1
- Death
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Fragmin 5 000 IE injeksjonsvæske, oppløsning i ferdigfylt sprøyte
PRD11139300 · Product
- Active substance
- Dalteparin Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 5000 IU international unit(s)
- Max total dose
- 5000 IU international unit(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AB04 — DALTEPARIN
- Marketing authorisation
- 23-15952
- MA holder
- PFIZER AS
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Plavix 75 mg film-coated tablets
PRD2912264 · Product
- Active substance
- Clopidogrel
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 75 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AC04 — CLOPIDOGREL
- Marketing authorisation
- EU/1/98/069/001
- MA holder
- SANOFI WINTHROP INDUSTRIE
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Akershus University Hospital
- Sponsor organisation
- Akershus University Hospital
- Address
- Sykehusveien 25
- City
- Loerenskog
- Postcode
- 1474
- Country
- Norway
Scientific contact point
- Organisation
- Akershus University Hospital
- Contact name
- Anders Erik Astrup Dahm
Public contact point
- Organisation
- Akershus University Hospital
- Contact name
- Anders Erik Astrup Dahm
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Ongoing, recruiting | 744 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Akershus University Hospital
Department of hematology, Sykehusveien 27, 1478, Lorenskog
Nordlandssykehuset HF
Department of Cancer, Parkveien 95, 8005, Bodo
St. Olavs Hospital HF
Department of oncology, Prinsesse Kristinas G. 3, 7030, Trondheim
Drammen Sykehus
Department of Oncology, Dronninggata 28, 3004, Drammen
Sykehuset Oestfold HF Kalnes
Oncology, Kalnesveien 300, 1714, Graalum
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Norway | 2025-08-21 | 2025-08-21 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-509022-22-00 Clean | 2.5 |
| Protocol (for publication) | D1_Protocol 2023-509022-22-00 Tracked | 2.4 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Letter to potensial healthy control group v_1_1 | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Biobank | 1.5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF healthy control group | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pancreatic cancer group | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pancreatic cancer group v_1_2 Tracked version | 1.2 |
| Summary of Product Characteristics (SmPC) (for publication) | E_2 SmPc Plavix | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPc Fragmin | 1 |
| Synopsis of the protocol (for publication) | D1_protocol synopsis MS norwegian 2023-509022-22-00 | 2 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-06 | Norway | Acceptable with conditions 2024-08-26
|
2024-08-26 |
| 2 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-15 | Norway | Acceptable 2025-10-16
|
2025-10-16 |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-03-05 | Norway | Acceptable 2026-05-11
|
2026-05-13 |