Cerebral Amyloid AngiopathyNCT04654026
the Safety and Efficacy of Antiplatelet Therapy in Patients of CAA
An observational study of Cerebral Amyloid Angiopathy, run by Shenzhen Second People's Hospital.
Trial summary
Ischemic cardiovascular and cerebrovascular diseases are the main causes of death among people. Antiplatelet threrapy is very important for patients to prevent ischemic cardiovascular and cerebrovascular diseases.Ischemic cardiovascular patients of cerebral amyloid angiopathy (CAA) patients is as high as 20%, aspirin… Read more about this study
- Who is it for?
- Ages 55 to 100 years
- Conditions the study is for
- Cerebral Amyloid Angiopathy
- What is being tested?
- Aspirin/Clopidogrel
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2021to 30 Oct 2023
- 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 55 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ischemic cardiovascular and cerebrovascular diseases in our hospital were included from January 2021 to December 2021, and from January 2021 to December 2021. All patients were male or female, aged ≥55 years.
Who may be able to join
- Clinical diagnosis of CAA
- Must be able to swallow tablets
Who cannot join
- Clopidogrel gene was non-CYP2C19 *1 patients.
- Patients with surgical thrombolysis .
- Patients with arteritis, aneurysms, arterial trauma and other risk factors were excluded.
- Patients with tumours, infections, fever, inflammatory diseases, post-embolization bleeding, peripheral vascular thrombosis or embolization, and other blood diseases such as hemophilia were excluded.
- Currently receiving treatment in another experimental device or drug study, or completing treatment in another experimental device or drug study ≤30 days.
- Patients are allergic to any of the ingredients known to be given aspirin or clopidogrel.
- Patients has an unstable medical condition, or is otherwise considered unstable by the investigator, based on medical history, physical examination, and routine laboratory tests.
- Patients who need to change or discontinue aspirin or clopidogrel, fail to take medication, or fail to come to the hospital on time due to their condition, and some information is missing.
About this study
Official title: Single-center, Prospective, Controlled Study of the Safety and Efficacy of Aspirin and Clopidogrel in Ischemic Cardiovascular and Cerebrovascular Patients Complications With CAA
Ischemic cardiovascular and cerebrovascular diseases are the main causes of death among people. Antiplatelet threrapy is very important for patients to prevent ischemic cardiovascular and cerebrovascular diseases.Ischemic cardiovascular patients of cerebral amyloid angiopathy (CAA) patients is as high as 20%, aspirin and clopidogrel is applied to prevent or treat the patient with CAA is controversial, there is no valid evidence of CAA crowd is safe to use of antiplatelet drugs, but progress in clinical treatment is usually based on patient condition for antiplatelet agents to prevent the occurrence of adverse events, such as blood clots.Therefore, this study is intended to be a single-center, prospective study of patients with ischemic cardiovascular and cerebrovascular diseases taking aspirin and clopidogrel, to determine whether the patients are combined with CAA , and to conduct a follow-up study for 12 months after team inclusion:1) The prevalence rate and gene spectrum of ischemic cardiovascular and cerebrovascular diseases among CAA patients enrolled in our hospital were analyzed;2) To explore the correlation between aspirin and clopidogrel drug genes and blood drug concentrations and diseases in patients with ischemic cardiovascular and cerebrovascular diseases complicated with CAA;3) To evaluate the efficacy and safety of aspirin and clopidogrel in patients with ischemic cardiovascular and cerebrovascular diseases who combined with CAA.
Read the detailed description
This project intends to observation of bleeding the application of antiplatelet in patients with CAA, so as to provide effective clinical evidence for the further application of clopidogrel and aspirin in patients with CAA in the future, and to provide reference basis for the accurate formulation of clinical treatment plans and the balance of health risks brought by adverse bleeding reactions.
- Conditions
- Cerebral Amyloid Angiopathy
- Being tested
- Aspirin/Clopidogrel
- Medical subject headings
- Cerebral Amyloid Angiopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin/ClopidogrelDrug
Also called ticagrelor
No intervention, only observational studies
| Study group | Role | What they receive |
|---|---|---|
| CAA Group | Patients with cardiovascular and cerebrovascular disease with cerebral amyloidosis Receives: Drug: Aspirin/Clopidogrel | |
| None CAA Group | Patients with cardio-cerebrovascular disease without cerebral amyloid vascular disease Receives: Drug: Aspirin/Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding
MRI evaluated the degree and location of microbleeding
Measured: MRI was used to assess bleeding at 180 ± 7 day and 360 ± 7 day. Cortical (lobar) hemorrhages were classified as microbleeds according to their size (<5 mm in diameter).
Secondary outcomes (1)
Neurological symptom evaluation
Barthel index
Measured: Barthel index was measures at 6 and 12 months. With ten ordinally scaled items, functional status (dependency on nursing) of the patients is assessed (range from 0 is completely dependent on care to 100 is completely independent).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start20 Feb 2021 (estimated)
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Amyloid AngiopathyStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Second People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654026
- Sponsor's protocol ID
- 20200601034-FS01
- Status last verified
- Nov 2020
- First submitted
- 11 Oct 2020
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Prospective, Controlled Study of the Safety and Efficacy of Aspirin and Clopidogrel in Ischemic Cardiovascular and Cerebrovascular Patients Complications With CAA
- ClinicalTrials.gov ID
- NCT04654026
- Acronym / sponsor ID
- 20200601034-FS01
- Conditions
- Cerebral Amyloid Angiopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Shenzhen Second People's HospitalUniversity, hospital or other
- Study start
- 20 Feb 2021 (estimated)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 4 Dec 2020 (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.
Ischemic cardiovascular and cerebrovascular diseases are the main causes of death among people. Antiplatelet threrapy is very important for patients to prevent ischemic cardiovascular and cerebrovascular diseases.Ischemic cardiovascular patients of cerebral amyloid angiopathy (CAA) patients is as high as 20%, aspirin and clopidogrel is applied to prevent or treat the patient with CAA is controversial, there is no valid evidence of CAA crowd is safe to use of antiplatelet drugs, but progress in clinical treatment is usually based on patient condition for antiplatelet agents to prevent the occurrence of adverse events, such as blood clots.Therefore, this study is intended to be a single-center, prospective study of patients with ischemic cardiovascular and cerebrovascular diseases taking aspirin and clopidogrel, to determine whether the patients are combined with CAA , and to conduct a follow-up study for 12 months after team inclusion:1) The prevalence rate and gene spectrum of ischemic cardiovascular and cerebrovascular diseases among CAA patients enrolled in our hospital were analyzed;2) To explore the correlation between aspirin and clopidogrel drug genes and blood drug concentrations and diseases in patients with ischemic cardiovascular and cerebrovascular diseases complicated with CAA;3) To evaluate the efficacy and safety of aspirin and clopidogrel in patients with ischemic cardiovascular and cerebrovascular diseases who combined with CAA.
Detailed description
This project intends to observation of bleeding the application of antiplatelet in patients with CAA, so as to provide effective clinical evidence for the further application of clopidogrel and aspirin in patients with CAA in the future, and to provide reference basis for the accurate formulation of clinical treatment plans and the balance of health risks brought by adverse bleeding reactions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAA Group | – | Drug: Aspirin/ClopidogrelPatients with cardiovascular and cerebrovascular disease with cerebral amyloidosis |
| None CAA Group | – | Drug: Aspirin/ClopidogrelPatients with cardio-cerebrovascular disease without cerebral amyloid vascular disease |
Who may qualify
- Ages
- 55 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ischemic cardiovascular and cerebrovascular diseases in our hospital were included from January 2021 to December 2021, and from January 2021 to December 2021. All patients were male or female, aged ≥55 years.
Key inclusion criteria (2 listed)
- Clinical diagnosis of CAA
- Must be able to swallow tablets
Key exclusion criteria (8 listed)
- Clopidogrel gene was non-CYP2C19 *1 patients.
- Patients with surgical thrombolysis .
- Patients with arteritis, aneurysms, arterial trauma and other risk factors were excluded.
- Patients with tumours, infections, fever, inflammatory diseases, post-embolization bleeding, peripheral vascular thrombosis or embolization, and other blood diseases such as hemophilia were excluded.
- Currently receiving treatment in another experimental device or drug study, or completing treatment in another experimental device or drug study ≤30 days.
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 |
|---|---|---|
| Aspirin/ClopidogrelAlso: ticagrelorNo intervention, only observational studies | Drug | CAA Group, None CAA Group |
Primary outcome
Bleeding
Time frame: MRI was used to assess bleeding at 180 ± 7 day and 360 ± 7 day. Cortical (lobar) hemorrhages were classified as microbleeds according to their size (<5 mm in diameter).
MRI evaluated the degree and location of microbleeding
1 secondary outcome
Neurological symptom evaluation
Time frame: Barthel index was measures at 6 and 12 months. With ten ordinally scaled items, functional status (dependency on nursing) of the patients is assessed (range from 0 is completely dependent on care to 100 is completely independent).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Amyloid Angiopathy, run by Shenzhen Second People's Hospital.
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 2 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 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Bleeding (time frame: MRI was used to assess bleeding at 180 ± 7 day and 360 ± 7 day. Cortical (lobar) hemorrhages were classified as microbleeds according to their size (<5 mm in diameter).). 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 8 Feb 2021.