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Personalized Antiplatelet Therapy based on Pharmacogenomics in Acute Minor Stroke and Transient Ischemic Attack

Personalized Antiplatelet Therapy based on Pharmacogenomics in Acute Minor Stroke and Transient Ischemic Attack

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800019911
Enrollment
Unknown
Registered
2018-12-08
Start date
2019-01-01
Completion date
Unknown
Last updated
2018-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Minor Stroke and Transient Ischemic Attack

Interventions

pharmacogenetic group:Patients randomly assigned to the pharmacogenetic group received a dose of 75 mg clopidogrel per day (ultra-metabolizers and extensive metabolizers group), 150mg clopidogrel per
standard group:P2Y12 receptor antagonist is selected by the clinician according to the clinical features of the patients.

Sponsors

Yangpu Hospital Tongji University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. aged 18 years or older; 2. diagnosis of an acute minor ischemic stroke or TIA; Acute minor stroke is defined as a sudden focal neurological dysfunction caused by vascular causes, and score of 3 or less at the time of randomization on the National Institutes of Health Stroke Scale (NIHSS; scores range from 0 to 42, with higher scores indicating greater deficits). TIA is defined as a transient episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction; 3. Onset of the acute minor ischemic stroke or TIA symptoms less than 72 h.

Exclusion criteria

Exclusion criteria: 1. hemorrhage; other conditions, such as vascular malformation, trauma, tumor, abscess, degenerative neurologic disease or other major nonischemic brain disease; 2. Systemic infectious diseases, autoimmune diseases, severe heart, liver and kidney diseases; 3. any contraindication to the use of aspirin or P2Y12 receptor antagonists; 4. prior knowledge of the patients CYP2C19*2, CYP2C19*3 or CYP2C19*17 genotype; 5. ongoing treatment in another observational or registry randomized trial; 6. an inability to provide informed consent or unavailability for follow-up. Based on the PLATO trial and PHARMCLO trial exclusion criteria, ticagrelor was contraindicated in patients: 1) with active pathological bleeding; 2) with a history of intracranial bleeding; 3) requiring dialysis; 4) taking oral anticoagulant therapy that could not be stopped; 5) with known clinically important thrombocytopenia; 6) receiving fibrinolytic therapy within the previous 24 hours; and 7) taking concomitant therapy with strong CYP3A inhibitors or inducers.

Design outcomes

Primary

MeasureTime frame
new stroke event (ischemic or hemorrhagic);

Secondary

MeasureTime frame
ischemic stroke;hemorrhagic stroke;myocardial infarction;vascular death;

Countries

China

Contacts

Public ContactYue Yun-hua

Yangpu Hospital Tongji University School of Medicine

447879206@qq.com+86 13916034986

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 21, 2026