the Safety and Efficacy of Antiplatelet Therapy in Patients of CAA

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cerebral Amyloid Angiopathy
• Intervention / Treatment: Drug: Aspirin/Clopidogrel

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 Type: Observational
• Enrollment (Anticipated): 43

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CAA Group; Patients with cardiovascular and cerebrovascular disease with cerebral amyloidosis	Drug: Aspirin/Clopidogrel; No intervention, only observational studies; Other Names: ticagrelor
None CAA Group; Patients with cardio-cerebrovascular disease without cerebral amyloid vascular disease	Drug: Aspirin/Clopidogrel; No intervention, only observational studies; Other Names: ticagrelor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurological symptom evaluation	Barthel index	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).

Collaborators and Investigators

• Sponsor: Shenzhen Second People's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): February 20, 2021
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): October 30, 2023

Study Registration Dates

• First Submitted: October 11, 2020
• First Submitted That Met QC Criteria: November 30, 2020
• First Posted (Actual): December 4, 2020

Study Record Updates

• Last Update Posted (Actual): February 8, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Proteostasis Deficiencies; Metabolism, Inborn Errors; Brain Diseases, Metabolic; Brain Diseases, Metabolic, Inborn; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Cerebral Small Vessel Diseases; Amyloidosis, Familial; Amyloidosis; Cerebral Amyloid Angiopathy; Cerebral Amyloid Angiopathy, Familial; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Aspirin; Ticagrelor; Clopidogrel
• Other Study ID Numbers: 20200601034-FS01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No