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

NCT04738097 | Completed Phase 3 DMC

• 1 other identifier: 4164
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

Ischemic Stroke; Transient Ischemic Attack

Keywords

minor stroke; secondary prevention; ticagrelor; aspirin; recurrence; non-cardioembolic; antiplatelet

Outcome Measures

Primary Outcomes (1)

• ischemic stroke recurrence

  recording new event based on new lesion on brain CT scan or MRI

  first 3 months after first event

Secondary Outcomes (3)

• Major hemorrhagic event

  during first 30 days

• ischemic stroke recurrence

  first 1 month after first event

• cardiovascular events

  during first 3 months after first event

Study Arms (2)

intervention

EXPERIMENTAL

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.

Drug: Ticagrelor 90mg

control

ACTIVE COMPARATOR

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.

Drug: Clopidogrel 75 mg

Interventions

Ticagrelor 90mg 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.

Also known as: Ticer

intervention

Clopidogrel 75 mg 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.

Also known as: Osvix

control

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mazandaran University of Medical Sciences: lead

Study Sites (2)

Athena Sharifi Razavi

Sari, Mazandaran, 4818777111, Iran

Location

Bou-Ali Sina hospital , Mazandarn University of Medical Science

Sari, Iran

Location

Related Links

• published study protocol article

MeSH Terms

Conditions

Ischemic Stroke; Ischemic Attack, Transient; Recurrence

Interventions

Ticagrelor; Clopidogrel

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Athena Sharifi-Razavi

  Mazandaran University of Medical science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor in Neurology

Study Record Dates

• First Submitted: January 31, 2021
• First Posted: February 4, 2021
• Study Start: August 8, 2021
• Primary Completion: October 10, 2023
• Study Completion: October 15, 2023
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: 6 months after publishing study results
• Access Criteria: requested by a scientifically person, who plan for similar protocol study

Locations

IR (2)