Genetic testing to guide antiplatelet therapy for ischemic stroke patients

Genotype Guided Antiplatelet Therapy in Ischemic Stroke

This study is testing if using genetic testing to guide antiplatelet therapy can help people who have had an ischemic stroke or transient ischemic attack avoid serious health problems better than standard treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 350 (estimated)
• Ages: 21 Years to 100 Years
• Sex: All
• Sponsor: National Neuroscience Institute (Academic / other)
• Locations: 1 site (Singapore)
• Trial ID: NCT05763862 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of genotype-guided antiplatelet therapy in patients who have experienced an ischemic stroke or transient ischemic attack. It focuses on patients with unknown CYP2C19 status, where randomization will determine whether they receive genetic testing or standard medical therapy. The study will involve three visits over a year, with blood tests conducted to assess genetic mutations that may affect the efficacy of clopidogrel, a common antiplatelet medication. The goal is to evaluate if personalized treatment based on genetic testing can reduce the risk of major cardiovascular or cerebrovascular events.

Who should consider this trial

Good fit: Ideal candidates are clopidogrel-naive patients aged 21 years and older who have recently experienced an ischemic stroke or transient ischemic attack.

Not a fit: Patients with known CYP2C19 status or those with a diagnosis of dementia or life-limiting illnesses may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective prevention strategies for recurrent strokes in patients with specific genetic profiles.

How similar studies have performed: Other studies have shown promise in using genetic testing to guide antiplatelet therapy, suggesting that this approach may be beneficial.

Eligibility criteria

Inclusion Criteria:

* Patients diagnosed with acute ischemic stroke or transient ischemic attack.
* Age 21 years to 100 years.
* Can be randomised within 7 days of onset of index event \[Refer to footnote 1\].
* Clopidogrel naive immediately prior to index event \[Refer to footnote 2\].

Footnote 1: Date of index event to be taken as Day 1. This means that randomisation must be done by Day 7. For unknown onset or wake-up stroke where the last seen well and symptoms discovery are on different days, Day 1 is taken to be the date of symptoms discovery. Footnote 2: Patients who were on short-term antiplatelets which included clopidogrel but are no longer on clopidogrel prior to stroke would fulfil for this inclusion criteria. In this context, short-term antiplatelets are defined as 21 days for minor stroke TIA and 3 months for large vessel disease.

Exclusion Criteria:

* Known diagnosis of dementia \[Refer to footnote 3\].
* Known diagnosis of a life limiting illness with life expectancy of less than 1 year.
* Known cardioembolism or prothrombotic state necessitating the use of anticoagulation, or having a contraindication to clopidogrel.

Footnote 3: "Known diagnosis of dementia" will be defined as clinical diagnosis of dementia prior to the index stroke event as indicated in the patient's medical records.

Where this trial is running

Singapore

• Singapore General Hospital — Singapore, Singapore (Recruiting)

Study contacts

• Principal investigator: Kaavya Narasimhalu — National Neuroscience Institute
• Study coordinator: Elaine Ang

Conditions Ischemic Stroke; Transient Ischemic Attack; Genotype Guided Antiplatelet Therapy