Evaluation of Clopidogrel and Dalteparin Sodium in Thromboprophylaxis for Pancreatic Ductal Adenocarcinoma Patients: A Randomized Clinical Trial

The primary objective of this study is to evaluate the **efficacy** and safety of adding antiplatelet therapy to standard thromboprophylaxis in patients with pancreatic ductal cancer. This is clinically relevant as it aims to address thrombotic disease, a common complication in these patients, potentially improving their overall management and outcomes.

Secondary objectives include investigating whether antiplatelet therapy, when added to standard thromboprophylaxis, enhances survival rates in patients with pancreatic ductal cancer. This could provide insights into optimizing treatment strategies for this patient population.

The clinical trial involves participants diagnosed with **pancreatic ductal cancer**, specifically those who are newly diagnosed with locally advanced, metastatic, or recurrent forms of the disease. The study population includes both male and female subjects over the age of 18, with no specific vulnerable populations being targeted. Participants are required to have a planned treatment for their pancreatic ductal cancer. The sponsor has not provided information regarding the total number of participants. The selection criteria focus on individuals who have been diagnosed preferably within the last month, ensuring that the study population is representative of patients at a similar stage of disease progression. Lifestyle considerations such as diet, physical activity, or habits are not specified in the available data.

The clinical trial is designed to evaluate the **efficacy** and safety of adding antiplatelet therapy to standard thromboprophylaxis in patients with pancreatic ductal cancer. This is a phase 3, randomized, double-blind, controlled trial. The trial will involve the administration of **clopidogrel** in the form of film-coated tablets and **dalteparin sodium** as a solution for injection. The trial is expected to commence on September 16, 2024, and conclude by September 16, 2034, with a maximum treatment period of 12 months for each participant.

Participants will be required to attend several study visits throughout the trial. The initial visit will be a screening visit to confirm eligibility based on criteria such as age (over 18 years) and a recent diagnosis of locally advanced, metastatic, or recurrent pancreatic ductal adenocarcinoma. Following the screening, eligible participants will be randomized to receive either the investigational treatment or a control. Subsequent follow-up visits will be scheduled to monitor the participants' response to the treatment and to assess any adverse events, with a focus on the primary endpoints of arterial or venous thrombosis and major bleeding. The end-of-study visit will occur at the conclusion of the treatment period or upon early termination.

The expected length of participant involvement is up to 12 months, depending on individual response and adherence to the study protocol. Conditions that may lead to early termination from the study include significant adverse events, withdrawal of consent, or any other medical condition that, in the opinion of the investigator, warrants discontinuation. The primary endpoint of the study is a composite of objectively verified arterial or venous thrombosis, while secondary endpoints include safety assessments such as major bleeding and mortality. The trial aims to provide valuable insights into the potential benefits and risks of combining antiplatelet therapy with standard thromboprophylaxis in this patient population.

The clinical trial involves the administration of **Plavix 75 mg film-coated tablets**, which contain the active substance **clopidogrel**. This medication is provided in the form of film-coated tablets and is administered orally. The dosage is set at 75 mg per day, with a maximum treatment period of 12 months. Clopidogrel is a chemical substance classified under the ATC code B01AC04, and it functions as an antiplatelet agent. The product is manufactured by Sanofi Winthrop Industrie and holds the marketing authorization number EU/1/98/069/001. Participant compliance with the dosing schedule will be monitored throughout the study to ensure adherence to the prescribed regimen.

Additionally, the trial includes the use of **Fragmin 5 000 IE solution for injection**, which contains the active substance **dalteparin sodium**. This medication is administered via subcutaneous injection, with a dosage of 5000 IU per day, also for a maximum treatment period of 12 months. Dalteparin sodium is a polymer-based substance, classified under the ATC code B01AB04, and is used as a standard thromboprophylaxis agent. The product is manufactured by Pfizer AS and is identified by the marketing authorization number 23-15952. The administration of Fragmin will be closely monitored to ensure proper dosing and participant compliance throughout the trial.

The efficacy of the clinical trial titled "Antiplatelet therapy added to standard thromboprophylaxis to prevent thrombosis in pancreatic cancer patients - a randomized clinical trial (The PANART trial)" will be assessed using a primary endpoint that comprises a composite of objectively verified arterial or venous thrombosis. This endpoint is designed to evaluate the effectiveness of adding antiplatelet therapy to standard thromboprophylaxis in patients with pancreatic ductal cancer. The trial will also monitor safety through the incidence of major bleeding as a primary safety endpoint.

Secondary endpoints include the assessment of death rates among participants. The trial is structured as a phase 3 randomized clinical trial, focusing on adult patients with newly diagnosed, locally advanced, metastatic, or recurrent pancreatic ductal adenocarcinoma. The trial is set to begin recruitment on September 16, 2024, and is estimated to conclude on September 16, 2034. The efficacy parameters will be collected and analyzed throughout the trial duration to determine the impact of the intervention on thrombotic disease in the specified patient population.