- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04548401
Effect of Antiplatelet Therapy on Cognition After Aneurysmal Subarachnoid Hemorrhage
September 10, 2020 updated by: Hai-Bin Shi, Nanjing Medical University
Deficits in memory, executive function, and language are common cognitive sequelae of aneurysmal subarachnoid hemorrhage (aSAH).
Previous study demonstrated that post-treatment antiplatelet therapy reduced risk for delayed cerebral ischemia caused by aSAH.
However, the effect of antiplatelet therapy on cognition after aSAH is unclear.
The aim of this study was to assess the effect of antiplatelet therapy on cognition after aSAH.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zhen Yu Jia, MD.
- Phone Number: +86 13770918208
- Email: zhenyu_jia@sina.com
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210009
- Recruiting
- The First Affiliated Hospital of Nanjing Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with aSAH who received endovascular treatment.
Description
Inclusion Criteria:
- 1. Patients with SAH in whom the aneurysm was proven by conventional angiography; 2. Baseline Hunt-Hess grade I-III; 3. patients received endovascular treatment
Exclusion Criteria:
- 1. Hunt-Hess grade IV-V; 2. Non-aneurysmal SAH; 3. Dementia in other diseases; 4. Lacking of 6-8 month MoCA evaluation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Antiplatelet-N group
Patients with ruptured aneurysm underwent coiling alone, without post-treatment antiplatelet therapy
|
|
Antiplatelet-Y group
Patients with ruptured aneurysm underwent stent assisted coiling, with post-treatment antiplatelet therapy (aspirin and/or clopidogrel or ticagrelor)
|
aspirin and/or clopidogrel or ticagrelor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Montreal Cognitive Assessment (MoCA) Test
Time Frame: 6-8 months
|
6-8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hai Bin Shi, MD, The First Affiliated Hospital with Nanjing Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 1, 2019
Primary Completion (ANTICIPATED)
October 31, 2021
Study Completion (ANTICIPATED)
December 31, 2021
Study Registration Dates
First Submitted
September 10, 2020
First Submitted That Met QC Criteria
September 10, 2020
First Posted (ACTUAL)
September 14, 2020
Study Record Updates
Last Update Posted (ACTUAL)
September 14, 2020
Last Update Submitted That Met QC Criteria
September 10, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- aSAH016
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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