Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06653348
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-19
Brief Title:
Ticagrelor Based De-Escalation of Dual Antiplatelet Therapy in Ischemic Stroke
Sponsor:
None
Organization:
None
Study Overview
Official Title:
De-Escalation of Dual Antiplatelet Therapy With Ticagrelor and Aspirin in Non-disabling Non-cardioembolic Ischemic Stroke or High Risk TIA Patients A Randomized Outcome Assessor Blind Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEDAPT-TICA
Brief Summary:
This is a randomized controlled outcome assessor blind parallel group design pilot study on 100 patient with diagnosis of ischemic stroke admitted in Bou-Ali Sina Hospital SariIranThe aim of study is to compare the efficacy of 90 mg ticagrelor BID plus aspirin for 1 month and 60 mg ticagrelor BID plus aspirin for 3 months in reduce of non-disabling non-cardioembolic ischemic stroke or high risk TIA recurrence during first 12 months
Detailed Description:
This is a randomized controlled parallel outcome assessor blind feasibility study The aim of study is assess the efficacy of ticagrelor de-escalation in reduce of non-disabling non-cardioembolic ischemic stroke or high risk TIA recurrence during first 12 months after primary event 100 patient with diagnosis of ischemic stroke admitted in Bou-Ali Sina Hospital Sari Iran will be randomized to intervention or control group by using 4 block randomization method Inclusion criteria is age40 signing inform consent recent ischemic stroke within 24 h diagnosed by brain CT or MRI mild stroke with NIHSS 8 and no evidence of large infarct in brain imaginghigh risk TIA with ABCD 4 no cardioembolic source such as low EF MS AF no specific etiology such as dissection vasculitis no carotid stenosis 50 in side of involvement Exclusion criteria is history of hypersensitivity to consumptive drug any indication for anticoagulant therapy acute phase treatment with intravenous thrombolysis or thrombectomy any contraindication for consumptive drug history of intracranial hemorrhage history of GI bleeding during past 6 m candidate for endarterectomy history of coagulopathy active hemorrhagic diathesis during randomization Patients in control group will be treat with standard ischemic stroke regiment including ASA 325 mg stat and ticagrelor 180 mg stat then ASA 80 mg and ticagrelor 90 mg BID for 1 month Then single antiplatelet therapy with ASA will be continue Intervention group will be treat with ASA 325 mg stat and ticagrelor 180 mg stat then ASA 80 mg daily and ticagrelor 90 mg BID for 1 month And Ticagrelor 60 mg BID plus ASA 80 mg daily until the end of month 3 Then single antiplatelet therapy with ASA will be continue Four fallow up visit plan by a neurologist or neurology resident on month 1 3 6 and 12Clinical data including NIHSS score MRS score and other data will record on case report form Stroke recurrence or cardiovsacular event is efficacy end point Major bleeding according to STIH criteria is study safety end point Primary outcome is ischemic stroke recurrence during first 12 months after first event documented by new lesion on brain CT or MRI Secondary outcome is major hemorrhagic events stroke recurrence during first 3 months and any cardiovascular event during first 12 month
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None