UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034933
Receipt No. 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 2019/05/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Institute International University of Health and Welfare
Institute
Department

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 Enrolling by invitation
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
2019 Year 05 Month 27 Day


Link to view the page
URL(English) https://upload.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


Contact us.