Ticagrelor Based De-Escalation of Dual Antiplatelet Therapy in Ischemic Stroke

NCT06653348 | Recruiting Phase 2 DMC

• 2 other identifiers: 23439mazmus
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke; Transient Ischemic Attack

Keywords

ischemic stroke; non-cardioembolic; non-disabling; TIA; Ticagrelor; de-escalation; dual antiplatelet therapy

Outcome Measures

Primary Outcomes (1)

• ischemic stroke recurrence

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

  12 months

Secondary Outcomes (1)

• Major hemorrhagic event

  during first 180 days

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 30 days. Then ticagrelor 60 mg BID and ASA 80 mg daily until the end of month 6.

Drug: Ticagrelor 60 + Aspirin

comparator

ACTIVE COMPARATOR

Comparator 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 30 days. Then ASA 80 mg daily until the end of month 6.

Drug: Ticagrelor 90 + aspirin

Interventions

Ticagrelor 60 + Aspirin DRUG

Ticagrelor 90 mg BID plus ASA 80 mg daily for 1 month and then ticagrelor 60 mg BID plus ASA 80 mg daily until the end of month 6.

intervention

Ticagrelor 90 + aspirin DRUG

ticagrelor 90 mg BID plus ASA 80 mg daily for 1 month.

comparator

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 (1)

Mazandaran province, Sari,Iran

Sari, Mazandaran, 4817844718, Iran

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Ischemic Attack, Transient

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Athena Sharifi Razavi, MD

CONTACT

+989113510136; athena.sharifi@yahoo.com

Nasim Tabrizi, MD

CONTACT

00989111263538; nasimtabrizi@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study designed to be blind to the outcome assessors, meaning that the neurologist evaluating the patients' outcomes was unaware of the treatment assignments.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Athena Sharifi Razavi

Study Record Dates

• First Submitted: October 19, 2024
• First Posted: October 22, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

IR (1)