Cerebrovascular StrokeNCT03772457
Predictive Value of Infarction Volume on Hemorrhagic Transformation in Ischemic Stroke/TIA With Non-valve Atrial Fibrillation(NVAF) Patients Using Rivaroxaban
An observational study of Cerebrovascular Stroke and Intracranial Hemorrhages, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study was aimed at patients with newly diagnosed stroke / TIA associated with nonvalvular atrial fibrillation. We will observe the effect of early using rivaroxaban anticoagulation on hemorrhagic transformation, and explore the predictive value of multi-mode MRI infarct volume / MMP-9 on hemorrhagic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Stroke, Intracranial Hemorrhages, Anticoagulant
- What is being tested?
- Rivaroxaban
- Type of treatment
- Pill or oral medicine
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 2019to 31 Dec 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Newly diagnosed ischemic stroke/TIA patients with NVAF who sign the informed consent and receiveRivaroxaban treatment in the in-patient ward.
Who may be able to join
- Male or female, age≥18;
- Were newly diagnosed asischemic stroke/TIA concomitant NVAF;
- Prescribedand accept Rivaroxaban;
- Sign thewritten informed consent.
Who cannot join
- Renal impairment (CrCl<15 ml/min) or severe hepatic impairment.
- Significant hemorrhagic transformation (parenchymal hematoma type I or type II by the ECASS definition).
- Stroke or TIA caused by large artery atherosclerosis
- Planned major surgery or invasive intervention
- Active internal bleeding
- Malignancy or other serious medical conditions with a life expectancy <6 months
- Allergery to Rivaroxaban
- Pregnancy or breast-feeding
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
MIN LOU, Ph.D., 8657187784811, loumingxc@vip.sina.com
MIN LOU, Ph.D.
About this study
Official title: To Explore the Predictive Value of Infarction Volume on Hemorrhagic Transformation in Newly Diagnosed Ischemic Stroke/TIA With Non-valve Atrial Fibrillation(NVAF) Patients Using Rivaroxaban
This study was aimed at patients with newly diagnosed stroke / TIA associated with nonvalvular atrial fibrillation. We will observe the effect of early using rivaroxaban anticoagulation on hemorrhagic transformation, and explore the predictive value of multi-mode MRI infarct volume / MMP-9 on hemorrhagic transformation after anticoagulation therapy.
- Conditions
- Cerebrovascular Stroke, Intracranial Hemorrhages, Anticoagulant, Matrix Metalloproteinases
- Being tested
- Rivaroxaban
- Medical subject headings
- Stroke, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
new oral anticoagulant molecules which is the selective factor Xa inhibitor
What is being measured
The primary outcome is the main question the study is designed to answer.
Susceptibility weighted imaging(SWI) detection of newly developed hemorrhagic transformation after 14 days of rivaroxaban treatment
Measured: 14 days after enrolling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start18 Jan 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular StrokeStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer, Taizhou Hospital, Zhuji People's Hospital of Zhejiang Province, Shaoxing People's Hospital, Jinhua Central Hospital, Haiyan People's Hospital, Wenzhou Central Hospital, The Central Hospital of Lishui City, Dongyang People's Hospital, The Third Affiliated Hospital of Wenzhou Medical University
- Responsible party
- Sponsor
- Investigators
- Min Lou, PhD, Study chair, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03772457
- Sponsor's protocol ID
- InV HT RAF 1010
- Status last verified
- Apr 2023
- First submitted
- 10 Oct 2017
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Explore the Predictive Value of Infarction Volume on Hemorrhagic Transformation in Newly Diagnosed Ischemic Stroke/TIA With Non-valve Atrial Fibrillation(NVAF) Patients Using Rivaroxaban
- ClinicalTrials.gov ID
- NCT03772457
- Acronym / sponsor ID
- InV HT RAF 1010
- Conditions
- Cerebrovascular Stroke, Intracranial Hemorrhages, Anticoagulant, Matrix Metalloproteinases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Bayer, Taizhou Hospital, Zhuji People's Hospital of Zhejiang Province, Shaoxing People's Hospital, Jinhua Central Hospital, Haiyan People's Hospital, Wenzhou Central Hospital, The Central Hospital of Lishui City, Dongyang People's Hospital, The Third Affiliated Hospital of Wenzhou Medical University
- Study start
- 18 Jan 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was aimed at patients with newly diagnosed stroke / TIA associated with nonvalvular atrial fibrillation. We will observe the effect of early using rivaroxaban anticoagulation on hemorrhagic transformation, and explore the predictive value of multi-mode MRI infarct volume / MMP-9 on hemorrhagic transformation after anticoagulation therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed ischemic stroke/TIA patients with NVAF who sign the informed consent and receiveRivaroxaban treatment in the in-patient ward.
Key inclusion criteria (4 listed)
- Male or female, age≥18;
- Were newly diagnosed asischemic stroke/TIA concomitant NVAF;
- Prescribedand accept Rivaroxaban;
- Sign thewritten informed consent.
Key exclusion criteria (8 listed)
- Renal impairment (CrCl<15 ml/min) or severe hepatic impairment.
- Significant hemorrhagic transformation (parenchymal hematoma type I or type II by the ECASS definition).
- Stroke or TIA caused by large artery atherosclerosis
- Planned major surgery or invasive intervention
- Active internal bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivaroxabannew oral anticoagulant molecules which is the selective factor Xa inhibitor | Drug | – |
Primary outcome
Susceptibility weighted imaging(SWI) detection of newly developed hemorrhagic transformation after 14 days of rivaroxaban treatment
Time frame: 14 days after enrolling
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Lou, PhD study chair
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Stroke and Intracranial Hemorrhages, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 4 inclusion and 8 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 18 Apr 2023. 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 China. 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.
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 Min Lou, PhD (13958007213, loumingxc@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Susceptibility weighted imaging(SWI) detection of newly developed hemorrhagic transformation after 14 days of rivaroxaban treatment (time frame: 14 days after enrolling). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2023.