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

October 18, 2023 updated by: Athena Sharifi Razavi, Mazandaran University of Medical Sciences

Ticagrelor Plus Aspirin vs Clopidogrel Plus Aspirin in Mild Non-cardioembolic Ischemic Stroke: A Randomized, Active Comparator Arm, Outcome Assessor Blind, Controlled, Feasibility Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Iran, Islamic Republic of
      • Sari, Iran, Islamic Republic of
        • Bou-Ali Sina hospital , Mazandarn University of Medical Science
    • Mazandaran
      • Sari, Mazandaran, Iran, Islamic Republic of, 4818777111
        • Athena Sharifi Razavi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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.
Other Names:
  • Ticer
Active Comparator: 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.
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.
Other Names:
  • Osvix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ischemic stroke recurrence
Time Frame: first 3 months after first event
recording new event based on new lesion on brain CT scan or MRI
first 3 months after first event

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major hemorrhagic event
Time Frame: during first 30 days
Major bleeds were defined according to the International Society of Thrombosis and Hemostasis (ISTH)
during first 30 days
ischemic stroke recurrence
Time Frame: first 1 month after first event
recording new event based on new lesion on brain CT scan or MRI
first 1 month after first event
cardiovascular events
Time Frame: during first 3 months after first event
any proven cardiovascular event
during first 3 months after first event

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mazandaran University of Medical Sciences

Investigators

  • Principal Investigator: Athena Sharifi-Razavi, mazandaran university of medical science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2021

Primary Completion (Actual)

October 10, 2023

Study Completion (Actual)

October 15, 2023

Study Registration Dates

First Submitted

January 31, 2021

First Submitted That Met QC Criteria

January 31, 2021

First Posted (Actual)

February 4, 2021

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4164

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be shared by request to principal investigator for scientifical reseasons

IPD Sharing Time Frame

6 months after publishing study results

IPD Sharing Access Criteria

requested by a scientifically person, who plan for similar protocol study

IPD Sharing Supporting Information Type

  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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