Efficacy of Ticagrelor Plus Aspirin in Mild Non-cardioembolic Ischemic Stroke

NCT ID: NCT04738097

Last Updated: 2023-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-08
• Study Completion Date: 2023-10-15

Brief Summary

This is a randomized, controlled, active comparator arm, outcome assessor blind, parallel group design on 90 patient with diagnosis of ischemic stroke admitted in Bou-Ali Sina Hospital, Sari,Iran.The aim of study is assess the efficacy of ticagrelor plus aspirin in reduce of minor non-cardioembolic ischemic stroke or high risk TIA recurrence during first 3 months.

Detailed Description

This is a randomized, controlled, parallel, active comparator arm, outcome assessor blind, feasibility study. The aim of study is assess the efficacy of ticagrelor plus aspirin in reduce of minor non-cardioembolic ischemic stroke or high risk TIA recurrence during first 3 months after primary event. 90 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 minor ischemic stroke regiment including ASA 325 mg stat and clopidogrel 300 mg stat, then ASA 80 mg and clopidogrel 75 mg daily for 21 days. 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 21 days. Then all groups will be treat with ASA 80 mg daily after day 21. Three fallow up visit plan by a neurologist or neurology resident on month 1 and 3.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 3 months after first event documented by new lesion on brain CT or MRI. Secondary outcome is major hemorrhagic events, stroke recurrence during first 30 days and any cardiovascular event during first 3 month.

Conditions

Ischemic Stroke; Transient Ischemic Attack

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

intervention

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 21 days.

Group Type: EXPERIMENTAL

Ticagrelor 90mg

Intervention Type: DRUG

ASA 325 mg stat and ticagrelor 180 mg stat, then ASA 80 mg daily and ticagrelor 90 mg BID for 21 days.Treatment will be continue with ASA 80 until 3 months.

control

control group will be treat with ASA 325 mg stat and clopidogrel 300 mg stat, then ASA 80 mg and clopidogrel 75 mg daily for 21 days.

Group Type: ACTIVE_COMPARATOR

Clopidogrel 75 mg

Intervention Type: DRUG

ASA 325 mg stat and clopidogrel 300 mg stat, then ASA 80 mg and clopidogrel 75 mg daily for 21 days.Treatment will be continue with ASA 80 until 3 months.

Interventions

Ticagrelor 90mg

ASA 325 mg stat and ticagrelor 180 mg stat, then ASA 80 mg daily and ticagrelor 90 mg BID for 21 days.Treatment will be continue with ASA 80 until 3 months.

Intervention Type: DRUG

Clopidogrel 75 mg

ASA 325 mg stat and clopidogrel 300 mg stat, then ASA 80 mg and clopidogrel 75 mg daily for 21 days.Treatment will be continue with ASA 80 until 3 months.

Intervention Type: DRUG

Other Intervention Names

Ticer; Osvix

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mazandaran University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Athena Sharifi Razavi

Assistant professor in Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Athena Sharifi-Razavi

Role: PRINCIPAL_INVESTIGATOR

Mazandaran University of Medical science

Locations

Athena Sharifi Razavi

Sari, Mazandaran, Iran

Bou-Ali Sina hospital , Mazandarn University of Medical Science

Sari, , Iran

Countries

Iran

Related Links

https://www.neurology-asia.org/articles/neuroasia-2023-28(3)-535.pdf

published study protocol article

Other Identifiers

4164

Identifier Type: -

Identifier Source: org_study_id