2023-509022-22-00RecruitingPhase 3
Antiplatelet therapy added to standard thromboprophylaxis to prevent thrombosis in pancreatic cancer patients - a randomized clinical trial (The PANART trial)
Akershus University Hospital5 sites in 1 country744 target enrollmentStarted: August 26, 2024Last updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 744
- Locations
- 5
- Primary Endpoint
- Efficacy: A composite of objectively verified arterial or venous thrombosis. Safety: Major bleeding.
Study Overview
Brief Summary
To investigate the efficacy and safety of adding antiplatelet theraphy to standard thromboprophylaxis on thrombotic disease in patients with pancreatic ductal cancer.
Study Design
- Allocation
- Randomized
- Primary Purpose
- The PANART-trial
- Masking
- None
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Participants are >18 years of age.
- •Newly diagnosed (preferably within the last month) locally advanced, metastatic or recurrent (after intended therapeutic treatment) pancreatic ductal adenocarcinoma.
- •Patients where there is planned some form of treatment for the pancreatic ductal cancer.
Exclusion Criteria
- •Current use of antiplatelet therapy or disease with indication for antiplatelet therapy not yet initiated.
- •Known hypersensitivity to clopidogrel or dalteparin
- •Known CYP2C19 genotype that influences clopidogrel metabolism (genotyping not necessary)
- •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)
Outcomes
Primary Outcomes
Efficacy: A composite of objectively verified arterial or venous thrombosis. Safety: Major bleeding.
Efficacy: A composite of objectively verified arterial or venous thrombosis. Safety: Major bleeding.
Secondary Outcomes
- Death
Investigators
Anders Erik Astrup Dahm
Scientific
Akershus University Hospital
Study Sites (5)
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