AzTrials
AzTrials

Cancer-associated ThrombosisPhase 2PRIORITYNCT03139487

A Randomized Phase II Open Label Study to Compare the Safety and Efficacy of Subcutaneous Dalteparin Versus Direct Oral Anticoagulants for Cancer-associated Venous Thromboembolism

A Phase 2 study testing Rivaroxaban, Dalteparin and apixaban in people with Cancer-associated Thrombosis and Esophageal Cancer, run by Asan Medical Center at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This is an open label, multi-center, and randomized phase II trial designed to compare the safety and efficacy of direct oral anticoagulants and subcutaneous dalteparin in patients with acute venous thromboembolism and upper gastrointestinal, hepatobiliary, or pancreatic cancer, based on a group sequential design. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Rivaroxaban, Dalteparin and apixaban
Could I receive a placebo?
No, everyone receives an active treatment
How many people
176 participants
Where
1 siteSouth Korea
Study dates
7 Aug 2017to 30 Sep 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed locally advanced or metastatic active cancer including Esophageal cancer, Esophagogastric junction cancer, Stomach cancer, Gastrointestinal stromal disease, Ampulla of Vater cancer, Duodenal cancer, Hepatocelluar carcinoma, Biliary cancer (cholangiocarcinoma, gall bladder cancer), Pancreatic cancer
  • Newly diagnosed deep vein thrombosis in any site and/or pulmonary thromboembolism on the basis of CT or doppler ultrasound image with or without symptoms
  • Male or female ≥ 18 years, < 80 years old age
  • Adequate major organ function including the following: Hematopoietic function: Platelet ≥ 75,000/mm3, Hepatic function: alanine aminotransferase levels 3 x upper limit of normal (if, with liver metastasis, alanine aminotransferase levels 5 x upper limit of normal), Aspartate Transaminase levels 3 x upper limit of normal (if, with liver metastasis, Aspartate Transaminase levels 5 x upper limit of normal), Renal function: estimated glomerular filtration rate ≥ 30 ml/min, Adequate coagulation time: prothrombin time ≤ 2 international normalized ratio, activated partial thromboplastin time 1.5 x upper limit of normal
  • Able to understand and comply with the requirement of the study and to provide written informed consent

Who cannot join

  • Patients will be excluded from the study for any of the following reasons:
  • Hemodynamically unstable pulmonary thromboembolism
  • Use with P-gp and strong CYP3A4 Inhibitors (e.g., ketoconazole, itraconazole, lopinavir/ritonavir, ritonavir, indinavir/ritonavir, and conivaptan) or inducers (e.g., carbamazepine, phenytoin, rifampin, St. John's wort)
  • Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (e.g. patients with partial or total gastrectomy can enter the study, but not those with a jejunostomy probe), or inability to take oral medication
  • Patients with current bleeding
  • Recent history of major or uncontrolled bleeding within the previous 4 weeks
Show all 16Show fewer
  • Severe malnutrition, BMI < 16
  • Patients who are receiving a therapeutic dose of rivaroxaban, low molecular weight heparin, fondaparinux, or unfractionated heparin for more than 72 hours before enrollment
  • Administration of a fibrinolytic agent for treatment of the current episode
  • Uncontrolled systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg
  • Patients who have to keep concurrent antiplatelet agent (e.g. aspirin, clopidogrel)
  • Patients who have clinical significant liver cirrhosis (Child Pugh score ≥ 7)
  • Inadequate cardiovascular function: New York Heart Association class III or IV heart disease, Unstable angina or myocardial infarction within the past 6 months, History of significant ventricular arrhythmia requiring medication with antiarrhythmics or significant conduction system abnormality
  • Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy, including infective endocarditis
  • History of or current brain metastases
  • Life expectancy less than 3 months

Trial locations and contacts

1 site in 1 country.

Sook Ryun Park, M.D., Ph.D. contact

+82-2-3010-3210

srpark@amc.seoul.kr

Seyoung Seo, M.D. contact

syseo@amc.seoul.kr

South Korea1 site, 1 recruiting

  • Asan Medical Center

    Seoul

    Sook Ryun Park, srpark@amc.seoul.kr

    Recruiting

Other trials in South Korea

About this study

Official title: A Randomized Phase II Open Label Study to Compare the Safety and Efficacy of Subcutaneous Dalteparin Versus Direct Oral Anticoagulants for Cancer-associated Venous Thromboembolism in Patients With Advanced Upper Gastrointestinal, Hepatobiliary and Pancreatic Cancer: PRIORITY

This is an open label, multi-center, and randomized phase II trial designed to compare the safety and efficacy of direct oral anticoagulants and subcutaneous dalteparin in patients with acute venous thromboembolism and upper gastrointestinal, hepatobiliary, or pancreatic cancer, based on a group sequential design. Enrolled patients will be randomized in a 1:1 ratio. Patients will be stratified by performance status, type of cancer, chemotherapy and medical centers.

Read the detailed description

This randomized II clinical trial will enrol patients with advanced upper gastrointestinal, hepatobiliary and pancreatic cancer who have venous thromboembolism (VTE), including pulmonary embolism and deep vein thrombosis. Patients will be randomized in a 1:1 ratio and stratified by performance status, type of cancer and medical centers. The enrolled patients will receive either subcutaneous dalteparin or DOAC(rivaroxaban, apixavan) according to randomization until the end of planned treatment schedules (six months), recurrence of VTE, clinical relevant bleeding, major bleeding, death or discontinuation of study treatment for any other reason (e.g. withdrawal of consent or discretion of the investigator). The primary end-point is the rate of clinical relevant bleeding event as defined as overt bleeding which was associated with medical intervention. In addition to time to clinical relevant bleeding event, time to event of major bleeding, total bleeding including minor event, time to recurrent VTE, overall bleeding rate and overall VTE recurrent rate will be analyzed to compare safety and efficacy of both anticoagulants. The final analysis will be conducted when the last enrolled patient has an event or has completed as least six months follow up in the study. Patients without bleeding and recurrent VTE events at data cut-off are censored at the last date the patient is known to be free of events.

Planned interim analysis will be conducted in the intentions to treatment analysis set. The interim analysis for the randomized portion of the study will be performed when at least 40% of estimated bleeding events have been observed. The purpose of interim analysis is for early stopping of the study for safety. This study will use a Data Monitoring Committee.

Being tested
Rivaroxaban, Dalteparin, apixaban
Keywords
Anticoagulant Adverse Reaction, Cancer-associated Thrombosis, Low molecular weight heparin, Direct oral anticoagulant
Medical subject headings
Esophageal Neoplasms, Stomach Neoplasms, Carcinoma, Hepatocellular, Pancreatic Neoplasms, Duodenal Neoplasms, Gastrointestinal Stromal Tumors, Biliary Tract Neoplasms, Cholangiocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RivaroxabanDrug

    Also called Xarelto

    15 mg q12 hours for 3 weeks followed by 20mg q24 hours for 21 weeks

  • DalteparinDrug

    Also called Fragmin

    200 IU/kg q24 hours for 4 weeks followed by 150 IU/kg q24 hours for 20 weeks

  • apixabanDrug

    Also called eliquis

    10 mg q12 hours for 7days followed by 5mg q12 hours for 21 weeks

Study groups in NCT03139487
Study groupRoleWhat they receive
Low molecular weight heparinActive comparatorDalteparin, 200 IU/kg subcutaneously once daily for 4 weeks followed by 150 IU/kg once daily for 20 weeks
Receives: Drug: Dalteparin
Direct oral anticoagulantExperimentalRivaroxaban, 15 mg orally twice daily for 3 weeks followed by 20mg once daily for 21 weeks Apixaban, 10 mg orally twice daily for 7days followed by 5mg twice daily for 21 weeks
Receives: Drug: Rivaroxaban; Drug: apixaban

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of clinical relevant bleeding

    Clinically relevant bleeding: overt bleeding which was associated with medical intervention, unscheduled contact with a physician, interruption or discontinuation of anticoagulation, or associated with any other discomfort such as pain or impairment of activities of daily life, including major bleeding

    Measured: 6 months

Secondary outcomes (7)

  1. Rate of major bleeding

    Major bleeding: Contributing to death, associated with a fall in hemoglobin ≧ 2 g/dL, or leading to transfusion of ≧ 2 units of red cells or if bleeding is intracranial, retroperitoneal, or another critical site.

    Measured: 6 months

  2. Rate of total event of bleeding

    Measured: 6 months

  3. Time to major bleeding event

    Measured: 6 months

  4. Time to clinical relevant bleeding event

    Measured: 6 months

  5. Time to total event of bleeding

    Measured: 6 months

  6. Rate of recurrent or aggravated venous thromboembolism

    Measured: 6 months

  7. Time to recurrent or aggravated venous thromboembolism

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2017
  2. Study start7 Aug 2017
  3. Primary completion30 Sep 2021 (estimated)
  4. Study completion30 Sep 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
176 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03139487
Sponsor's protocol ID
S2017-0327
Acronym
PRIORITY
Status last verified
Jan 2020
First submitted
2 May 2017
Last updated
6 Jan 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Riaz IB, Fuentes HE, Naqvi SAA, He H, Sipra QR, Tafur AJ, Padranos L, Wysokinski WE, Marshall AL, Vandvik PO, Montori V, Bryce AH, Liu H, Badgett RG, Murad MH, McBane RD 2nd. Direct Oral Anticoagulants Compared With Dalteparin for Treatment of Cancer-Associated Thrombosis: A Living, Interactive Systematic Review and Network Meta-analysis. Mayo Clin Proc. 2022 Feb;97(2):308-324. doi: 10.1016/j.mayocp.2020.10.041. Epub 2021 Jun 22.

    PubMed 34172290

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rivaroxaban, Dalteparin and apixaban in people with Cancer-associated Thrombosis and Esophageal Cancer, run by Asan Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sook Ryun Park, M.D., Ph.D. (+82-2-3010-3210, srpark@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of clinical relevant bleeding (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03139487, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in