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

NCT06486363 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 2023-536-02
• Study Type: interventional
• Target: 196
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Intracranial Aneurysms; Antiplatelet Drugs

Outcome Measures

Primary Outcomes (3)

• Incidence rate of cerebral stroke

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

  The entire experimental process after endovascular treatment

• Modified Rankin Scale

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

  6 months after endovascular surgery

• 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

  6 months after endovascular surgery

Secondary Outcomes (1)

• Platelet inhibition rate/platelet aggregation rate

  1 day before endovascular surgery/3 days after endovascular surgery/3 and 6 months after endovascular surgery

Study Arms (2)

Aspirin combined with clopidogrel

ACTIVE COMPARATOR

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

Aspirin combined with half-dose ticagrelor

EXPERIMENTAL

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

Aspirin combined with clopidogrel DRUG

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

Aspirin combined with clopidogrel

Aspirin combined with half-dose ticagrelor DRUG

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

Aspirin combined with half-dose ticagrelor

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

MeSH Terms

Conditions

Intracranial Aneurysm

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Shijie Na, Doctor

  The Affiliated Nanjing Drum Tower Hospital of Nanjing university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zong Zhuang, Doctor

CONTACT

+86 15850560410; zhuangzong@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief physician of Neurosurgery, Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: July 3, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share