Unique ID issued by UMIN | UMIN000034933 |
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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 |
Prospective Registry of rivaroxaban management of cancer-associated venous thromboembolism study
PRIMECAST
Prospective Registry of rivaroxaban management of cancer-associated venous thromboembolism study
PRIMECAST
Japan |
Cancer-associated venous Thromboembolism
Cardiology | Pneumology | Vascular surgery |
Malignancy
NO
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.
Safety,Efficacy
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.
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.
Observational
18 | years-old | <= |
Not applicable |
Male and Female
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
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.
500
1st name | Tetsuro |
Middle name | |
Last name | Miyata |
International University of Health and Welfare
department of medication
286-8686
Kozunomori 4-3, Narita City, Chiba Prefecture, 286-8686
0476-20-7701
tmiyata29@gmail.com
1st name | Yuichi |
Middle name | |
Last name | Tamura |
International University of Health and Welfare
Cardiovascular internal medicine
286-8686
Kozunomori 4-3, Narita City, Chiba Prefecture, 286-8686
0476-20-7701
tamura.u1@gmail.com
International University of Health and Welfare
Bayer Yakuhin, Ltd
Profit organization
International University of Health and Welfare, Mita Hospital
1-4-3 Mita, Minato-ku Tokyo, 108-832
03-3451-8121
soumu-mita.hosp@iuhw.ac.jp
NO
2018 | Year | 11 | Month | 19 | Day |
Unpublished
No longer recruiting
2018 | Year | 07 | Month | 06 | Day |
2018 | Year | 08 | Month | 01 | Day |
2019 | Year | 02 | Month | 01 | Day |
2023 | Year | 12 | Month | 31 | Day |
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.
2018 | Year | 11 | Month | 19 | Day |
2022 | Year | 05 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039832
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