the Safety and Efficacy of Antiplatelet Therapy in Patients of CAA

• Sponsor: Shenzhen Second People's Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04654026
• Collaborator: (none)
• Enrollment: 43
• Anticipated Duration (Months): 32.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Amyloid Angiopathy	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 Design

• Study Type: Observational
• Anticipated Enrollment: 43 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• 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
• Anticipated Study Start Date: Feb 20, 2021
• Anticipated Primary Completion Date: Dec 30, 2022
• Anticipated Study Completion Date: Oct 30, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Bleeding [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

Secondary Outcome Measures

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).]

   Barthel index

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Shenzhen Second People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shenzhen Second People's Hospital
• ClinicalTrials.gov Identifier: NCT04654026
• Other Study ID Numbers: 20200601034-FS01
• First Posted: Dec 4, 2020
• Last Update Posted: Feb 8, 2021
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cerebral Amyloid Angiopathy; Cerebral Amyloid Angiopathy, Familial; Aspirin; Clopidogrel; Ticagrelor

Study Results

No Results Posted as of Feb 8, 2021