Ticagrelor Based De-Escalation of Dual Antiplatelet Therapy in Ischemic Stroke (DEDAPT-TICA)

Mazandaran University of Medical Sciences

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Ischemic Stroke; Transient Ischemic Attack

Treatments: Drug: Ticagrelor 60 + Aspirin; Drug: Ticagrelor 90 + aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT06653348

mazmus (Other Grant/Funding Number)

23439

Details and patient eligibility

About

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.

Full description

This is a randomized, controlled, parallel, outcome assessor blind, feasibility study. The aim of study is assess the efficacy of ticagrelor de-escalation in reduce of non-disabling non-cardioembolic ischemic stroke or high risk TIA recurrence during first 12 months after primary event. 100 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 ischemic stroke regiment including ASA 325 mg stat and ticagrelor 180 mg stat, then ASA 80 mg and ticagrelor 90 mg BID for 1 month. Then single antiplatelet therapy with ASA will be continue. 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 1 month. And, Ticagrelor 60 mg BID plus ASA 80 mg daily until the end of month 6. Then single antiplatelet therapy with ASA will be continue. Four fallow up visit plan by a neurologist or neurology resident on month 1, 3, 6 and 12.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 12 months after first event documented by new lesion on brain CT or MRI. Secondary outcome is major hemorrhagic events, stroke recurrence during first 6 months and any cardiovascular event during first 12 month.

Enrollment: 100 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

intervention

Experimental group

Description:

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.

Treatment:

Drug: Ticagrelor 60 + Aspirin

comparator

Active Comparator group

Description:

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.

Treatment:

Drug: Ticagrelor 90 + aspirin