Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04738097
Recruitment Status : Recruiting
First Posted : February 4, 2021
Last Update Posted : September 2, 2021
Sponsor:
Information provided by (Responsible Party):
Athena Sharifi Razavi, Mazandaran University of Medical Sciences

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Transient Ischemic Attack Drug: Ticagrelor 90mg Drug: Clopidogrel 75 mg Phase 3

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,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 diatesis 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 cardiovacular event is efficacy end point. Major bleeding according to STICH 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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Ticagrelor Plus Aspirin vs Clopidogrel Plus Aspirin in MInor Non-cardioembolic Ischemic Stroke: A Randomized, Active Comparator Arm, Outcome Assessor Blind, Conrolled, Feasibility Study
Actual Study Start Date : August 8, 2021
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: Ticer
Active Comparator: control
control gruop 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 Name: Osvix


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. ischemic stroke recurrence [ Time Frame: first 3 months after first event ]
    recording new event based on new lesion on brain CT scan or MRI


Secondary Outcome Measures :
  1. Major hemorrhagic event [ Time Frame: during first 30 days ]
    Major bleeds were defined according to the International Society of Thrombosis and Hemostasis (ISTH)

  2. ischemic stroke recurrence [ Time Frame: first 1 month after first event ]
    recording new event based on new lesion on brain CT scan or MRI

  3. cardiovascular events [ Time Frame: during first 3 months after first event ]
    any proven cardiovascular event


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • signing inform consent,
  • recent ischemic stroke within 24 h,
  • diagnosed by brain CT or MRI mild stroke (non lacunar) with NIHSS =<8,
  • 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 diatesis during randomization
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04738097


Contacts
Layout table for location contacts
Contact: Athena Sharifi-Razavi 00989113510136 athena.sharifi@yahoo.com
Contact: Nasim Tabrizi nasimtbrizi@gmail.com

Locations
Layout table for location information
Iran, Islamic Republic of
Athena Sharifi Razavi Recruiting
Sari, Mazandaran, Iran, Islamic Republic of, 4818777111
Contact: athena sharifi razavi, MD    00989113510136    athena.sharifi@yahoo.com   
Bou-Ali Sina hospital , Mazandarn University of Medical Science Not yet recruiting
Sari, Iran, Islamic Republic of
Contact: athena sharifi razavi    00989113510136    athena.sharifi@yahoo.com   
Sponsors and Collaborators
Mazandaran University of Medical Sciences
Investigators
Layout table for investigator information
Principal Investigator: Athena Sharifi-Razavi Mazandaran University of Medical science
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Athena Sharifi Razavi, Assistant professor in Neurology, Mazandaran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT04738097    
Other Study ID Numbers: 4164
First Posted: February 4, 2021    Key Record Dates
Last Update Posted: September 2, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be shared by request to principal investigator for scientifical reseasons
Supporting Materials: Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: 6 months after publishing study results
Access Criteria: requested by a scientifically person, who plan for similar protocol study

Layout table for additional information
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
Keywords provided by Athena Sharifi Razavi, Mazandaran University of Medical Sciences:
minor stroke
secondary prevention
ticagrelor
aspirin
 recurrence
non-cardioembolic
antiplatelet
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Ischemic Stroke
Cerebral Infarction
Ischemic Attack, Transient
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
 Brain Ischemia
Infarction
Necrosis
Clopidogrel
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs