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Not yet recruitingNCT06486363Updated Jul 29, 2024

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

A Phase 4 interventional study of Aspirin combined with clopidogrel and Aspirin combined with half-dose ticagrelor in Intracranial Aneurysms and Antiplatelet Drugs, sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Not yet recruiting. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-07-29.

Sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
196
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
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Study summary

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

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Conditions studied

  • Intracranial Aneurysms
  • Antiplatelet Drugs
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In context

Intracranial Aneurysm

427 studies on the registry are indexed under Intracranial Aneurysm; 115 are open to participants now.

This study's planned enrollment of 196 is above the median of 110 across 207 interventional studies indexed under Intracranial Aneurysm.

Browse Intracranial Aneurysm studies →

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School is the lead sponsor of 242 studies on the registry; 144 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Use of drugs that affect coagulation function or significant abnormalities in platelet/coagulation function before admission;
  2. Previous history of cardiovascular and cerebrovascular disease;
  3. Complications of major organ dysfunction, chronic inflammatory diseases or malignant tumors at admission;
  4. Known allergy or contraindication to heparin, aspirin, clopidogrel, or ticagrelor;
  5. Patients with any severe or active pathological bleeding;
  6. Pregnant and lactating female;
  7. Those deemed unsuitable to participate in this trial by the responsible physician
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
196 participants (estimated)

Study arms

  • Active comparator
    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 clopidogrel

  • Experimental
    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.

    Drug: Aspirin combined with half-dose ticagrelor

Interventions

  • DrugAspirin 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

  • DrugAspirin 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

06

What researchers measure

Primary outcomes

  1. Incidence rate of cerebral stroke

    Incidence rate of cerebral stroke, including ischemic stroke and hemorrhagic stroke

    Time frame: The entire experimental process after endovascular treatment

  2. Modified Rankin Scale

    Modified Rankin Scale ( The scale runs from 0 to 6, 0 means perfect health and 6 means death)

    Time frame: 6 months after endovascular surgery

  3. Mini-mental state examination

    The MMSE examination includes time and place orientation, registration, attention and calculation, recall, language, repitition, complex commands. Score excess 24 or more indicates a normal cognition, 19-23 points indicates mild cognitive impairment, score of 10-18 points indicates moderate cognitive impairment and score below 9 points indicates severe cognitive impairment

    Time frame: 6 months after endovascular surgery

Secondary outcomes

  1. Platelet inhibition rate/platelet aggregation rate

    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

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Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06486363
Lead sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Responsible party
Shijie Na (Deputy chief physician of Neurosurgery, Principal Investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School) — Principal investigator
First posted
Jul 3, 2024
Start date
Aug 1, 2024 (estimated)
Primary completion
Jul 31, 2026 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
Jul 29, 2024

Study contacts

Zong Zhuang, Doctor
Contact
zhuangzong@126.com
+86 15850560410
Shijie Na, Doctor
principal investigator · The Affiliated Nanjing Drum Tower Hospital of Nanjing university

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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