Study on Clopidogrel and Dalteparin Sodium for Preventing Blood Clots in Pancreatic Cancer Patients

3 1 1 1

What is this study about?

This clinical trial is focused on patients with pancreatic cancer, specifically a type known as pancreatic ductal cancer. The study aims to explore the effects of adding an additional treatment to the standard care that is usually given to prevent blood clots, which are known as thrombosis. The additional treatment being tested is called antiplatelet therapy, which involves using medications that help prevent blood cells called platelets from clumping together and forming clots.

In this study, two medications are being used. The first is Plavix, which contains the active ingredient clopidogrel and is taken as a film-coated tablet. The second is Fragmin, which contains dalteparin sodium and is given as an injection. The purpose of the study is to see if adding antiplatelet therapy to the usual treatment can more effectively prevent blood clots in patients with pancreatic cancer.

Participants in the study will receive either the standard treatment alone or the standard treatment plus the antiplatelet therapy. The study will last for up to 12 months, during which time the safety and effectiveness of the treatments will be monitored. The goal is to determine if the combination of treatments can reduce the risk of blood clots without causing significant side effects, such as major bleeding.

1 joining the trial

Upon joining the trial, participants will be informed about the study’s purpose, which is to investigate the effectiveness and safety of adding antiplatelet therapy to standard treatment to prevent blood clots in patients with pancreatic cancer.

Participants must be over 18 years old and have been recently diagnosed with locally advanced, metastatic, or recurrent pancreatic ductal adenocarcinoma.

2 medication administration

Participants will receive two types of medications: Plavix 75 mg film-coated tablets and Fragmin 5,000 IE solution for injection.

Plavix is taken orally, which means it is swallowed as a tablet. The dosage is 75 mg, and it is taken once daily.

Fragmin is administered through a subcutaneous injection, which means it is injected under the skin. The dosage is 5,000 international units (IE), and it is given once daily.

3 monitoring and follow-up

Participants will be regularly monitored for any signs of blood clots or major bleeding, as these are the primary focus of the study.

Regular follow-up appointments will be scheduled to assess the participant’s health and the effectiveness of the treatment.

4 completion of the trial

The trial is expected to continue until September 16, 2034. Participants will be informed about the end of their involvement in the study and any necessary follow-up care.

The results of the trial will contribute to understanding the benefits and risks of adding antiplatelet therapy to standard treatment for preventing blood clots in pancreatic cancer patients.

Who Can Join the Study?

Participants must be over 18 years old.
Participants must have been newly diagnosed with pancreatic ductal adenocarcinoma, which is a type of pancreatic cancer. This diagnosis should preferably be within the last month.
The cancer can be locally advanced (spread to nearby areas), metastatic (spread to other parts of the body), or recurrent (returned after treatment).
There must be a planned treatment for the pancreatic ductal cancer.

Who Cannot Join the Study?

Patients who do not have pancreatic ductal cancer cannot participate.
Patients who are not within the specified age range cannot participate. The study is open to adults and older adults.
Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
St. Olavs Hospital HF	Trondheim	Norway
Nordlandssykehuset HF	Bodo	Norway
Drammen Sykehus	Drammen	Norway
Sykehuset Oestfold HF Kalnes	Graalum	Norway
Ahcyhdcf Ungnydeeos Hyhasujr	Lorenskog	Norway

Trial status

Country	Status	Recruitment Start
Norway	Recruiting	16.09.2024

Trial locations

Investigated drugs:

Antiplatelet therapy is a type of treatment that helps prevent blood cells called platelets from sticking together and forming clots. In this trial, it is being added to the usual treatment to see if it can better prevent blood clots in patients with pancreatic cancer. Blood clots can be dangerous because they can block blood flow in the body, so this therapy aims to reduce that risk.

Standard thromboprophylaxis is the regular treatment given to patients to prevent blood clots. It usually involves medications that thin the blood, making it less likely for clots to form. In this trial, it serves as the base treatment to which the antiplatelet therapy is added, to see if the combination is more effective in preventing clots in patients with pancreatic cancer.

Investigated diseases:

Pancreatic carcinoma

Pancreatic ductal cancer – Pancreatic ductal cancer is a type of cancer that begins in the ducts of the pancreas, which are responsible for transporting digestive enzymes. It typically starts when cells in the pancreatic ducts undergo mutations and begin to grow uncontrollably, forming a tumor. As the disease progresses, the tumor can invade nearby tissues and organs, potentially spreading to other parts of the body. The growth of the tumor can obstruct the bile duct, leading to jaundice, or block the pancreatic duct, causing digestive issues. Over time, the cancer may metastasize, affecting distant organs such as the liver or lungs. The progression of the disease can lead to various complications, impacting the patient’s overall health and quality of life.

Trial ID:

2023-509022-22-00

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on Clopidogrel and Dalteparin Sodium for Preventing Blood Clots in Pancreatic Cancer Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?