Cerebrovascular DiseasePhase 1NCT03471169
Individualized Antithrombotic Therapy for Patients With Ischemic Cerebrovascular Disease
A Phase 1 study testing Desirable TEG and Undesirable TEG in people with Cerebrovascular Disease, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
To investigate the therapeutic effect of individualized treatment of antiplatelet in secondary prevention of ischemic stroke. Read more about this study
- Who is it for?
- Ages 14 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebrovascular Disease
- What is being tested?
- Desirable TEG and Undesirable TEG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2017to 1 Dec 2018
- Phase
- Phase 1
- 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 14 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 14 years of age or older
- no gender aspirin or clopidogrel for ischemic cerebrovascular disease Primary or secondary prevention of ischemic stroke patients
- The researcher (or principal) signs the informed consent form
Who cannot join
- Significant head trauma or stroke in the last 3 months
- 3 months to accept intracranial, spinal surgery or other parts of large surgery
- In the last week there is an incurable part of the artery puncture
- Acute bleeding constitution, including platelet count <100 × 109 / L or other conditions
- within the last 48h heparin treatment, APTT higher than the upper limit of normal range
- Oral anticoagulant: INR> 1.7 or PT> 15s
Show all 15Show fewer
- The presence of intracranial tumors, aneurysms or arteriovenous malformations
- Patients with any of the following cardioembolic-related illnesses are identified: rheumatic mitral or aortic stenosis, prosthetic heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, Open foramen ovale, left ventricular mural thrombus or valvular vegetation, congestive heart failure, bacterial endocarditis, or any other cardiovascular disease not suitable for enrollment; (as determined by the investigator)
- Severe liver and kidney dysfunction
- Life expectancy is less than 1 year
- Pregnant or lactating women
- Participating in other clinical studies, or have participated in other clinical studies within the 3 months before enrolling, or have already participated in this research
- Allergic or intolerant to aspirin or clopidogrel
- There are stomach lesions, such as gastritis, gastric ulcer and so on
- Do not want to follow-up or poor treatment compliance
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
XuanWu hospital
Beijing, Xicheng, 100053
qian Zhang, 13911256080, zhangqian_zq630@sina.com
About this study
Official title: Studies on the Individualized Prevention of Cerebrovascular Disease Using Study on Antithrombotic Therapy in Beijing
To investigate the therapeutic effect of individualized treatment of antiplatelet in secondary prevention of ischemic stroke.
Read the detailed description
Ischemic stroke is a leading cause of disability and death worldwide. Antiplatelet treatment is one of treatment strategies in secondary stroke prevention for patients with non-cardioemoblism etiology. However, a concerning issue is that wide interindividual variability in P2Y12 antagonist, especially clopidogrel. The rate on-treatment high platelet reactivity (HPR) can be as high as in one-third of patients with standard dose of clopidogrel( i.e. 75mg), and HPR has been noted in those who received other P2Y12 antagonists, such as ticagrelor and prasugrel. In the present study, we aimed to investigate the safety and potential therapeutic effect of individualized treatment of antiplatelet in secondary prevention in a cohort of patients with non-cardioembolic ischemic strokes.
- Conditions
- Cerebrovascular Disease
- Being tested
- Desirable TEG, Undesirable TEG
- Keywords
- antithrombotic therapy
- Medical subject headings
- Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desirable TEGDrug
Also called blood sampling
Change the type and dose of antithrombotic therapy and obtain desirable TEG results.
Antithrombotic drugs inclued Bayaspirin®，Plavix ® and Cilostazol.
Undesirable TEGDrug
Also called blood sampling
Don't change the type and dose of antithrombotic therapy and obtain undesirable TEG results. Antithrombotic drugs inclued Bayaspirin®，Plavix ® and Cilostazol.
| Study group | Role | What they receive |
|---|---|---|
| Desirable TEG | Experimental | Patients receiving antiplatelet medication and desirable thrombelastogram(TEG) test results. Receives: Drug: Desirable TEG |
| Undesirable TEG | Sham comparator | Patients receiving antiplatelet medication and undesirable thrombelastogram(TEG) test results. Receives: Drug: Undesirable TEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficient Aspirin
The value of inhibition rate of Aspirin > 50%
Measured: one year
Secondary outcomes (1)
Efficient Clopidogrel
The value of adenosine diphosphate> 30%
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start1 Apr 2017
- Primary completion1 Dec 2018 (estimated)
- Study completion1 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qian Zhang, 1, Study director, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471169
- Sponsor's protocol ID
- jinqiaowml
- Status last verified
- Nov 2017
- First submitted
- 5 Dec 2017
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies on the Individualized Prevention of Cerebrovascular Disease Using Study on Antithrombotic Therapy in Beijing
- ClinicalTrials.gov ID
- NCT03471169
- Acronym / sponsor ID
- jinqiaowml
- Conditions
- Cerebrovascular Disease
- Keywords
- antithrombotic therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital, Peking University People's Hospital
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 20 Mar 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.
To investigate the therapeutic effect of individualized treatment of antiplatelet in secondary prevention of ischemic stroke.
Detailed description
Ischemic stroke is a leading cause of disability and death worldwide. Antiplatelet treatment is one of treatment strategies in secondary stroke prevention for patients with non-cardioemoblism etiology. However, a concerning issue is that wide interindividual variability in P2Y12 antagonist, especially clopidogrel. The rate on-treatment high platelet reactivity (HPR) can be as high as in one-third of patients with standard dose of clopidogrel( i.e. 75mg), and HPR has been noted in those who received other P2Y12 antagonists, such as ticagrelor and prasugrel. In the present study, we aimed to investigate the safety and potential therapeutic effect of individualized treatment of antiplatelet in secondary prevention in a cohort of patients with non-cardioembolic ischemic strokes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desirable TEG | Experimental | Drug: Desirable TEGPatients receiving antiplatelet medication and desirable thrombelastogram(TEG) test results. |
| Undesirable TEG | Sham comparator | Drug: Undesirable TEGPatients receiving antiplatelet medication and undesirable thrombelastogram(TEG) test results. |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 14 years of age or older
- no gender aspirin or clopidogrel for ischemic cerebrovascular disease Primary or secondary prevention of ischemic stroke patients
- The researcher (or principal) signs the informed consent form
Key exclusion criteria (15 listed)
- Significant head trauma or stroke in the last 3 months
- 3 months to accept intracranial, spinal surgery or other parts of large surgery
- In the last week there is an incurable part of the artery puncture
- Acute bleeding constitution, including platelet count <100 × 109 / L or other conditions
- within the last 48h heparin treatment, APTT higher than the upper limit of normal range
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 |
|---|---|---|
| Desirable TEGAlso: blood samplingChange the type and dose of antithrombotic therapy and obtain desirable TEG results. Antithrombotic drugs inclued Bayaspirin®，Plavix ® and Cilostazol. | Drug | Desirable TEG |
| Undesirable TEGAlso: blood samplingDon't change the type and dose of antithrombotic therapy and obtain undesirable TEG results. Antithrombotic drugs inclued Bayaspirin®，Plavix ® and Cilostazol. | Drug | Undesirable TEG |
Primary outcome
Efficient Aspirin
Time frame: one year
The value of inhibition rate of Aspirin > 50%
1 secondary outcome
Efficient Clopidogrel
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
- Individual participant dataSharing planned: No
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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.
Qian Zhang, 1 study director
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Desirable TEG and Undesirable TEG in people with Cerebrovascular Disease, run by Xuanwu Hospital, Beijing 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 15 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 20 Mar 2018. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Moli Wang, 1 (13801234991, yifanhahahah@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficient Aspirin (time frame: one year). 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 20 Mar 2018.