Clinical trial NCT06653348: Ticagrelor Based De-Escalation of Dual Antiplatelet Therapy in Ischemic Stroke
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Ischemic Stroke
Transient Ischemic Attack
Keywords: ischemic stroke
non-cardioembolic
non-disabling
TIA
Ticagrelor
de-escalation
dual antiplatelet therapy
Lead sponsor: Mazandaran University of Medical Sciences
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* 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:

* 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

Primary outcomes:
measure: ischemic stroke recurrence
timeFrame: 12 months
Secondary outcomes:
measure: Major hemorrhagic event
timeFrame: during first 180 days
Other outcomes:
Locations:
city: Sari
country: Iran, Islamic Republic of
facility: Mazandaran province, Sari,Iran
state: Mazandaran
Study officials:
References: