the Safety and Efficacy of Antiplatelet Therapy in Patients of CAA

NCT04654026 | Unknown DMC

• 1 other identifier: 20200601034-FS01
• Study Type: observational
• Target: 43
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Cerebral Amyloid Angiopathy

Outcome Measures

Primary Outcomes (1)

• Bleeding

  MRI evaluated the degree and location of microbleeding

  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 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).

Study Arms (2)

CAA Group

Patients with cardiovascular and cerebrovascular disease with cerebral amyloidosis

Drug: Aspirin/Clopidogrel

None CAA Group

Patients with cardio-cerebrovascular disease without cerebral amyloid vascular disease

Drug: Aspirin/Clopidogrel

Interventions

Aspirin/Clopidogrel DRUG

No intervention, only observational studies

Also known as: ticagrelor

CAA Group; None CAA Group

Eligibility Criteria

• Age: 55 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Clinical diagnosis of CAA
• Must be able to swallow tablets

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen Second People's Hospital: lead

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Cerebral Amyloid Angiopathy

Interventions

Aspirin; Clopidogrel; Ticagrelor

Condition Hierarchy (Ancestors)

Cerebral Arterial Diseases; Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Amyloidosis; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Adenosine; Purine Nucleosides; Purines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2020
• First Posted: December 4, 2020
• Study Start: February 20, 2021
• Primary Completion: December 30, 2022
• Study Completion: October 30, 2023
• Last Updated: February 8, 2021

Record last verified: 2020-11