Ticagrelor Based De-Escalation of Dual Antiplatelet Therapy in Ischemic Stroke
- Conditions
- Ischemic StrokeTransient Ischemic Attack
- Interventions
- Registration Number
- NCT06653348
- Lead Sponsor
- Mazandaran University of Medical Sciences
- 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, Sari,Iran.The 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 6 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 : age\>40, 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 imaging.,high risk TIA with ABCD \>4, no cardioembolic source such as low E/F, 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 6. 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 12.Clinical 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 6 months and any cardiovascular event during first 12 month.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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 imaging
- high risk TIA with ABCD >4,
- no cardioembolic source such as low E/F, MS, AF ,...
- no specific etiology such as dissection, vasculitis, ...
- no carotid stenosis > 50 % in side of involvement
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description intervention Ticagrelor 60 + Aspirin 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 30 days. Then ticagrelor 60 mg BID and ASA 80 mg daily until the end of month 6. comparator Ticagrelor 90 + aspirin Comparator 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 30 days. Then ASA 80 mg daily until the end of month 6.
- Primary Outcome Measures
Name Time Method ischemic stroke recurrence 12 months recording new event based on new lesion on brain CT scan or MRI
- Secondary Outcome Measures
Name Time Method Major hemorrhagic event during first 180 days Major bleeds were defined according to the International Society of Thrombosis and Hemostasis (ISTH)
Trial Locations
- Locations (1)
Mazandaran province, Sari,Iran
🇮🇷Sari, Mazandaran, Iran, Islamic Republic of