UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034933
Receipt number R000039832
Scientific Title Prospective Registry of rivaroxaban management of cancer-associated venous thromboembolism study
Date of disclosure of the study information 2018/11/19
Last modified on 2022/05/24 09:44:39

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Basic information

Public title

Prospective Registry of rivaroxaban management of cancer-associated venous thromboembolism study

Acronym

PRIMECAST

Scientific Title

Prospective Registry of rivaroxaban management of cancer-associated venous thromboembolism study

Scientific Title:Acronym

PRIMECAST

Region

Japan


Condition

Condition

Cancer-associated venous Thromboembolism

Classification by specialty

Cardiology Pneumology Vascular surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

In this prospective observational study of non-vitamin K antagonist oral anticoagulant, which has become newly available in clinical use, for venous thromboembolism (VTE) in cancer-carrying patients, the therapeutic effects on venous thromboembolism and prognosis of this drug as well as the incidence of hemorrhagic adverse events will be examined to establish the therapeutic method for venous thromboembolism in cancer patients and evaluate the hemorrhagic risks.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Recurrence/aggravation of symptomatic venous thromboembolism

All the patients suspected for efficacy or safety events and all the cases of death will be judged by the event evaluation committee based on detailed data to decide the event applicable. The event evaluation committee is authorized to ask the physician in charge for the supply of additional information necessary for the judgment of these events.
Each endpoint will be assessed by descriptive statistics, and will not be compared between study drugs.

Key secondary outcomes

Clinically relevant bleeding events
Clinically irrelevant bleeding events
We define ISTH major bleeding as clinically relevant bleeding events. Thus, clinically irrelevant bleeding events include bleeding not meeting ISTH major bleeding, but requiring medical intervention, unscheduled consultation with a physician, temporary discontinuation of study treatment, pain, or impairment of daily activities.
And we are planning to establish external event judgement committee.
All adverse events
PE-DVT clot regression (disappearance, reduction, no change, or aggravation of PE and DVT are assessed by CT scanning and lower-extremity venous ultrasound, respectively)
It will be assessed by CT scanning and lower-extremity venous ultrasound (Yamada N et al., Thrombosis J., 17; 13: 2, 2015).
Relation with antitumor agents (effect of metabolism by CYP3A4)
Implementation of chemotherapy as planned
Implementation of surgical intervention as planned
Treatment compliance to outpatient treatment
Hospitalization and duration of hospitalization for treatment of VTE
Deaths (VTE-related deaths, cardiovascular deaths, cancer deaths, all deaths)
Recurrence of symptomatic VTE in the patients who have completed or discontinued treatment for VTE
Change in D-dimer
Change in INR (only in the patients treated with warfarin)
Performance status (PS)
Evaluation of risk factors in the ASCO guidelines (such as venous device)

All the patients suspected for efficacy or safety events and all the cases of death will be judged by the event evaluation committee based on detailed data to decide the event applicable. The event evaluation committee is authorized to ask the physician in charge for the supply of additional information necessary for the judgment of these events.
Each endpoint will be assessed by descriptive statistics, and will not be compared between study drugs.


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients aged 18 years or older at the time of informed consent
2. Patients who have any of solid cancer.
3. Patients who developed venous thromboembolism (acute pulmonary thromboembolism or acute deep vein thrombosis) after cancer incidence and started treatment with the study drugs. It does not matter whether it is symptomatic or asymptomatic.
4. Patients who have provided written consent for participation in this study within 12 weeks after the start of administration of the study drugs

Key exclusion criteria

1. Patients who have passed at least 2 weeks from diagnosis of VTE to the start of anticoagulant therapy.
2. Patients to whom the study drugs are contraindicated (see the package inserts)
3. Patients with active hemorrhage at the time of diagnosis of VTE
4. Other patients who are judged to be inappropriate by the physician in charge
Ex. Inability or unwillingness to comply with the study related procedures, or employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator, etc.
5. Patients who are unlikely to receive anticoagulant therapy over three months.

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Tetsuro
Middle name
Last name Miyata

Organization

International University of Health and Welfare

Division name

department of medication

Zip code

286-8686

Address

Kozunomori 4-3, Narita City, Chiba Prefecture, 286-8686

TEL

0476-20-7701

Email

tmiyata29@gmail.com


Public contact

Name of contact person

1st name Yuichi
Middle name
Last name Tamura

Organization

International University of Health and Welfare

Division name

Cardiovascular internal medicine

Zip code

286-8686

Address

Kozunomori 4-3, Narita City, Chiba Prefecture, 286-8686

TEL

0476-20-7701

Homepage URL


Email

tamura.u1@gmail.com


Sponsor or person

Institute

International University of Health and Welfare

Institute

Department

Personal name



Funding Source

Organization

Bayer Yakuhin, Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

International University of Health and Welfare, Mita Hospital

Address

1-4-3 Mita, Minato-ku Tokyo, 108-832

Tel

03-3451-8121

Email

soumu-mita.hosp@iuhw.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2018 Year 11 Month 19 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2018 Year 07 Month 06 Day

Date of IRB

2018 Year 08 Month 01 Day

Anticipated trial start date

2019 Year 02 Month 01 Day

Last follow-up date

2023 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Registration of the cancer carrying patients who developed venous thromboembolism and underwent anticoagulant therapy: Consecutive registration meting the inclusion criteria

Group A: Anticoagulation therapy with rivaroxaban: 500 patients
Group B: Anticoagulation therapy with warfarin: Enroll by Group A is packed

In the case of death due to the underlying disease (cancer) within 24 weeks, obtain the record from registration to death and perform the following two analyses.
- Analysis excluding the cases of cancer-induced death
- Set the time of cancer-induced death as interruption of observation.


Management information

Registered date

2018 Year 11 Month 19 Day

Last modified on

2022 Year 05 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039832


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name