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Not yet recruiting NCT06486363

Comparison of the Antiplatelet Efficacy of Aspirin Combined With Clopidogrel and Aspirin Combined With Half-dose Ticagrelor in Patients With Unruptured Intracranial Aneurysms With Normal CYP2C19 Metabolizer Phenotype

Phase IV Interventional Intracranial Aneurysms Antiplatelet Drugs

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aspirin combined with clopidogrel, Aspirin combined with half-dose ticagrelor.
Who it may be relevant to
Registry conditions: Intracranial Aneurysms, Antiplatelet Drugs. Basic parameters: 20 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The goal of this clinical trial is to compare the antiplatelet efficacy of aspirin combined with clopidogrel and aspirin combined with half-dose ticagrelor in in patients with unruptured intracranial aneurysms with normal CYP2C19 metabolizer phenotype. The main questions it aims to answer are: If aspirin combined with half-dose ticagrelor is comparable to or better than aspirin combined with clopidogrel? What medical problems do participants have when taking aspirin combined with half-dose ticagrelor? Researchers will compare aspirin combined with half-dose ticagrelor to aspirin combined with clopidogrel to see if aspirin combined with half-dose ticagrelor works to treat patients with unruptured intracranial aneurysms received endovascular treatment. Participants will: Take aspirin combined with half-dose ticagrelor or aspirin combined with clopidogrel every day for 6 months Visit the clinic 1 month and 6 months for checkups and tests

Interventions

  • Drug Aspirin combined with clopidogrel
    Participants in this group shall take Aspirin (100 mg/day) + clopidogrel (75 mg/day) for at least 5 days before receiving stent-assisted coil embolization, and take same medication for 6 months after endovascular treatment
  • Drug Aspirin combined with half-dose ticagrelor
    Participants in this group shall take Aspirin (100 mg/day) + half dose of ticagrelor (45 mg, 12 hours/time), at least for 3 days before receiving stent-assisted coil embolization, and take same medication for 6 months after endovascular treatment

Primary outcome measures

  • Incidence rate of cerebral stroke [Time frame: The entire experimental process after endovascular treatment]
  • Modified Rankin Scale [Time frame: 6 months after endovascular surgery]
  • Mini-mental state examination [Time frame: 6 months after endovascular surgery]
Secondary outcome measures (1)
  • Platelet inhibition rate/platelet aggregation rate [Time frame: 1 day before endovascular surgery/3 days after endovascular surgery/3 and 6 months after endovascular surgery]

Eligibility criteria

Inclusion criteria

  • Patients with unruptured intracranial aneurysms who are scheduled for stent-assisted embolization;
  • mRS score less than or equal to 2 on admission;
  • Normal CYP2C19 metabolizer genotype;
  • Age 20 or above, 70 or below, regardless of gender;
  • The subject or the entrusted family member voluntarily signed the informed consent for this trial

Exclusion criteria

  • Use of drugs that affect coagulation function or significant abnormalities in platelet/coagulation function before admission;
  • Previous history of cardiovascular and cerebrovascular disease;
  • Complications of major organ dysfunction, chronic inflammatory diseases or malignant tumors at admission;
  • Known allergy or contraindication to heparin, aspirin, clopidogrel, or ticagrelor;
  • Patients with any severe or active pathological bleeding;
  • Pregnant and lactating female;
  • Those deemed unsuitable to participate in this trial by the responsible physician

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06486363 · 2023-536-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗