Effect of Antiplatelet Therapy on Cognition After Aneurysmal Subarachnoid Hemorrhage

Sponsor

Nanjing Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04548401

Collaborator

(none)

200

Enrollment

Location

Anticipated Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Aneurysmal Subarachnoid Hemorrhage	Drug: Antiplatelet Drug

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Effect of Antiplatelet Therapy on Cognition After Aneurysmal Subarachnoid Hemorrhage

Actual Study Start Date :

Nov 1, 2019

Anticipated Primary Completion Date :

Oct 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	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)	Drug: Antiplatelet Drug aspirin and/or clopidogrel or ticagrelor

Arm

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)

Drug: Antiplatelet Drug

aspirin and/or clopidogrel or ticagrelor

Outcome Measures

Primary Outcome Measures

Montreal Cognitive Assessment (MoCA) Test [6-8 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu	China	210009

Sponsors and Collaborators

Nanjing Medical University

Investigators

Principal Investigator: Hai Bin Shi, MD, The First Affiliated Hospital with Nanjing Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hai-Bin Shi, Professor, Nanjing Medical University

ClinicalTrials.gov Identifier:

NCT04548401

Other Study ID Numbers:

aSAH016

First Posted:

Sep 14, 2020

Last Update Posted:

Sep 14, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Subarachnoid Hemorrhage

Hemorrhage

Platelet Aggregation Inhibitors

Study Results

No Results Posted as of Sep 14, 2020