Using Ticagrelor to Adjust Antiplatelet Therapy for Ischemic Stroke
De-Escalation of Dual Antiplatelet Therapy With Ticagrelor and Aspirin in Non-disabling Non-cardioembolic Ischemic Stroke or High Risk TIA Patients: A Randomized, Outcome Assessor Blind, Controlled Trial
PHASE2; PHASE3 · Mazandaran University of Medical Sciences · NCT06653348
This study is testing whether taking a lower dose of ticagrelor with aspirin for six months is better than a higher dose for one month in preventing more strokes in people who have had a non-disabling stroke or high-risk TIA.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Mazandaran University of Medical Sciences (other) |
| Locations | 1 site (Sari, Mazandaran) |
| Trial ID | NCT06653348 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the effectiveness of a de-escalation approach to dual antiplatelet therapy in patients with non-disabling non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA). A total of 100 patients will be randomized to receive either a higher dose of ticagrelor plus aspirin for one month or a lower dose for six months. The study aims to determine which regimen better reduces the recurrence of ischemic events within the first year after the initial stroke. Participants will be closely monitored for outcomes using a controlled and blinded methodology.
Who should consider this trial
Good fit: Ideal candidates are adults over 40 who have experienced a recent mild ischemic stroke or high-risk TIA.
Not a fit: Patients with a history of hypersensitivity to the study drugs or those requiring anticoagulant therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective management of ischemic stroke and TIA, potentially reducing recurrence rates.
How similar studies have performed: While there have been studies on antiplatelet therapy, this specific de-escalation approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Sari, Mazandaran
- Mazandaran province, Sari,Iran — Sari, Mazandaran, Iran (RECRUITING)
Study contacts
- Study coordinator: Athena Sharifi Razavi, MD
- Email: athena.sharifi@yahoo.com
- Phone: +989113510136
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ischemic Stroke, Transient Ischemic Attack, ischemic stroke, non-cardioembolic, non-disabling, TIA, Ticagrelor, de-escalation