Cardioembolic StrokeNCT02181361
Hirudin Plus Aspirin in the Secondary Prevention of Cardioembolic Stroke Due to Nonvalvular Atrial Fibrillation
An observational study of Cardioembolic Stroke and Atrial Fibrillation, run by Xijing Hospital at 1 site in China.
Trial summary
To investigate the efficacy and safety of hirudin plus aspirin therapy compared with warfarin in the secondary prevention of cardioembolic stroke due to nonvalvular atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardioembolic Stroke, Atrial Fibrillation
- What is being tested?
- hirudin plus aspirin and Warfarin
- Type of treatment
- Pill or oral medicine
- How many people
- 239 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to Oct 2018
- 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: Cardioembolic stroke patients due to nonvalvular atrialf ibrillation.
Who may be able to join
- age of 18 or older with NVAF-related cardioembolic stroke
- diagnosis of cardioembolic stroke conformed to the TOAST (Trial of Org 10172 in Acute Stroke Treatment) classification system in terms of the typical clinical presentation, neuroimaging profile, and vascular and cardiac evaluation
- patients who were after 14 days of stroke onset and with stable clinical status.
Who cannot join
- patients with rheumatic heart disease or history of heart valve surgery;
- patients with acute coronary syndrome or percutaneous coronary intervention within 30 days previous to enrollment;
- patients with active infective endocarditis;
- patients with purpura disease or blood coagulation disorder;
- patients who had active bleeding or the tendency to bleed;
- patients with history of intracranial hemorrhage (ICH) or other serious bleeding events;
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- patients diagnosed with peptic ulcer disease within 30 days previous to enrollment;
- patients who had esophageal varices;
- patients who had trauma or major surgery within 30 days previous to enrollment or patients who planned to have major surgery;
- patients with persistent blood pressure of 180/100mmHg or greater with or without anti-hypertension treatment;
- patients who need chronic anticoagulant treatment due to disorders other than AF;
- patients with severe liver and kidney dysfunction;
- patients who were allergic to warfarin, aspirin or hirudin;
- female patients who are pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy and Safety of Hirudin Plus Aspirin Versus Warfarin in the Secondary Prevention of Cardioembolic Stroke Due to Nonvalvular Atrial Fibrillation: a Prospective Cohort Study
To investigate the efficacy and safety of hirudin plus aspirin therapy compared with warfarin in the secondary prevention of cardioembolic stroke due to nonvalvular atrial fibrillation.
Read the detailed description
For the patients with cardioembolic stroke due to atrial fibrillation,guidelines recommended warfarin as the secondary prevention therapy. But warfarin has its disadvantages such as risk of bleeding and the requirement of frequent INR monitoring. The underuse of warfarin is a prominent problem in China. In our study, patients with cardioembolic stroke were treated with hirudin plus aspirin or warfarin. The aim of our study was to compare efficacy and safety of hirudin plus aspirin and warfarin in secondary prevention of cardioembolic stroke due to nonvalvular atrial fibrillation.
- Conditions
- Cardioembolic Stroke, Atrial Fibrillation
- Being tested
- hirudin plus aspirin, Warfarin
- Keywords
- atrial fibrillation, cardioembolic stroke, Hirudin, aspirin, warfarin
- Medical subject headings
- Embolic Stroke, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hirudin plus aspirinDrug
natural hirudin 0.75g, three times a day (Brand name: Maixuekang capsule, Guizhou Xinbang Pharmaceutical Co., China) and aspirin 100mg, once daily
WarfarinDrug
an initial dose of 1.25mg once daily. Three days later, INR of patients was checked every three days and the dose of warfarin was adjusted until reach the target range of 2 to 3. Since then INR monitoring was performed at 1, 2, 3, 6, 9, 12 months after stroke onset, targeting an INR between 2 and 3 and the dose of warfarin was adjusted accordingly.
| Study group | Role | What they receive |
|---|---|---|
| hirudin plus aspirin | 14 days after stroke onset, patients in the hirudin plus aspirin group received natural hirudin 0.75g, three times a day and aspirin 100mg, once daily. Receives: Drug: hirudin plus aspirin | |
| Warfarin | 14 days after stroke onset, patients in warfarin group were given an initial dose of 1.25mg of warfarin,once daily. 3 days later, INR of patients was checked every three days and the dose of warfarin was adjusted until reach the target range of 2 to 3. Since then INR monitoring was performed at 1, 2, 3, 6, 9, 12 months after stroke onset, targeting an INR between 2 and 3 and the dose of warfarin was adjusted accordingly. Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy outcome event: the recurrence of cardioembolic stroke
To compare the recurrence of cardioembolic stroke in hirudin plus aspirin group and the warfarin group.
Measured: One year after stroke onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2016
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardioembolic StrokeStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xi'an Central Hospital, Shaanxi Provincial People's Hospital, The Third Hospital of PLA, Hanzhong Central Hospital, Xianyang 215 hospital, Yulin Second Hospital, Yan'an University Affiliated Hospital, Baoji Central Hospital, Ankang Central Hospital, Baoji People's Hospital, Yan'an People's Hospital, 451 Hospital, Shangluo Central Hospital, Central Hospital of China Railway 20th Bureau, Xiangyang Central Hospital, Xi'an Ninth Hospital, Shangluo Second People's Hospital
- Responsible party
- Sponsor
- Investigators
- wen jiang, MD,PhD, Study chair, The Department of Neurology , Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02181361
- Sponsor's protocol ID
- Xijing-4-3
- Status last verified
- Sep 2013
- First submitted
- 3 Jun 2014
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Hirudin Plus Aspirin Versus Warfarin in the Secondary Prevention of Cardioembolic Stroke Due to Nonvalvular Atrial Fibrillation: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02181361
- Acronym / sponsor ID
- Xijing-4-3
- Conditions
- Cardioembolic Stroke, Atrial Fibrillation
- Keywords
- atrial fibrillation, cardioembolic stroke, Hirudin, aspirin, warfarin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- Xi'an Central Hospital, Shaanxi Provincial People's Hospital, The Third Hospital of PLA, Hanzhong Central Hospital, Xianyang 215 hospital, Yulin Second Hospital, Yan'an University Affiliated Hospital, Baoji Central Hospital, Ankang Central Hospital, Baoji People's Hospital, Yan'an People's Hospital, 451 Hospital, Shangluo Central Hospital, Central Hospital of China Railway 20th Bureau, Xiangyang Central Hospital, Xi'an Ninth Hospital, Shangluo Second People's Hospital
- Study start
- Jun 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 3 Jul 2014 (estimated)
- 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.
To investigate the efficacy and safety of hirudin plus aspirin therapy compared with warfarin in the secondary prevention of cardioembolic stroke due to nonvalvular atrial fibrillation.
Detailed description
For the patients with cardioembolic stroke due to atrial fibrillation,guidelines recommended warfarin as the secondary prevention therapy. But warfarin has its disadvantages such as risk of bleeding and the requirement of frequent INR monitoring. The underuse of warfarin is a prominent problem in China. In our study, patients with cardioembolic stroke were treated with hirudin plus aspirin or warfarin. The aim of our study was to compare efficacy and safety of hirudin plus aspirin and warfarin in secondary prevention of cardioembolic stroke due to nonvalvular atrial fibrillation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hirudin plus aspirin | – | Drug: hirudin plus aspirin14 days after stroke onset, patients in the hirudin plus aspirin group received natural hirudin 0.75g, three times a day and aspirin 100mg, once daily. |
| Warfarin | – | Drug: Warfarin14 days after stroke onset, patients in warfarin group were given an initial dose of 1.25mg of warfarin,once daily. 3 days later, INR of patients was checked every three days and the dose of warfarin was adjusted until reach the target range of 2 to 3. Since then INR monitoring was performed at 1, 2, 3, 6, 9, 12 months after stroke onset, targeting an INR between 2 and 3 and the dose of warfarin was adjusted accordingly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardioembolic stroke patients due to nonvalvular atrialf ibrillation.
Key inclusion criteria (3 listed)
- age of 18 or older with NVAF-related cardioembolic stroke
- diagnosis of cardioembolic stroke conformed to the TOAST (Trial of Org 10172 in Acute Stroke Treatment) classification system in terms of the typical clinical presentation, neuroimaging profile, and vascular and cardiac evaluation
- patients who were after 14 days of stroke onset and with stable clinical status.
Key exclusion criteria (14 listed)
- patients with rheumatic heart disease or history of heart valve surgery;
- patients with acute coronary syndrome or percutaneous coronary intervention within 30 days previous to enrollment;
- patients with active infective endocarditis;
- patients with purpura disease or blood coagulation disorder;
- patients who had active bleeding or the tendency to bleed;
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 |
|---|---|---|
| hirudin plus aspirinnatural hirudin 0.75g, three times a day (Brand name: Maixuekang capsule, Guizhou Xinbang Pharmaceutical Co., China) and aspirin 100mg, once daily | Drug | hirudin plus aspirin |
| Warfarinan initial dose of 1.25mg once daily. Three days later, INR of patients was checked every three days and the dose of warfarin was adjusted until reach the target range of 2 to 3. Since then INR monitoring was performed at 1, 2, 3, 6, 9, 12 months after stroke onset, targeting an INR between 2 and 3 and the dose of warfarin was adjusted accordingly. | Drug | Warfarin |
Primary outcome
Efficacy outcome event: the recurrence of cardioembolic stroke
Time frame: One year after stroke onset
To compare the recurrence of cardioembolic stroke in hirudin plus aspirin group and the warfarin group.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
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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.
wen jiang, MD,PhD study chair
The Department of Neurology , Xijing Hospital
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 Cardioembolic Stroke and Atrial Fibrillation, run by Xijing Hospital 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 3 inclusion and 14 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: finished, as of the sponsor's last update on 21 Apr 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy outcome event: the recurrence of cardioembolic stroke (time frame: One year after stroke onset). 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 21 Apr 2020.