Intracranial Aneurysm
Conditions
Keywords
Intracranial Aneurysm, Interventional Therapy, Stent, Platelet, Ischemic Stroke, Bleeding Event
Brief summary
The use of intracranial stents expands the possibilities for endovascular treatment of intracranial aneurysms and improves the success rate. However, it also increases the risk of ischemic complications in patients. The current standard dual antiplatelet regimen is considered crucial in reducing thrombotic events. Nevertheless, some patients exhibit resistance to antiplatelet drugs, which puts them at a higher risk of thrombotic events. In clinical practice, there is a lack of standardized platelet function testing and consensus on adjusting antiplatelet drug programs. This study conducted a multi-center, prospective cluster randomized controlled trial to investigate whether antiplatelet adjustment therapy guided by light transmittance aggregometry (LTA) detection can decrease the occurrence of ischemic events after stent implantation in patients with unruptured intracranial aneurysms. Additionally, the study aimed to establish a set of standardized antiplatelet regimens.
Interventions
DRUGAdjustment of Antiplatelet Drugs
The maximum platelet aggregation rate induced by arachidonic acid (AA-MPA)≥20%, give aspirin 200mg qd. The maximum platelet aggregation rate induced by adenosine diphosphatase (ADP-MPA)≥36.4% for flow diversion, give ticagrelor 60mg bid. ADP-MPA≥42.9% for stent-assisted coil embolization，give ticagrelor 60mg bid. ADP-MPA\<20%, give clopidogrel 37.5mg qd. The timing of drug adjustment should be at least 1 day before stent implantation, and the LTA testing should be performed again 48 hours after the drug adjustment. For patients whose ADP-MPA does not reach the normal range, a second antiplatelet drug adjustment should be performed: ticagrelor overdose: reduce to 45mg bid; ticagrelor resistance, increase to 90 mg bid.
Sponsors
Xuanwu Hospital, Beijing
Chinese PLA General Hospital
Beijing Chao Yang Hospital
Peking University International Hospital
Peking University First Hospital
Hebei Medical University Third Hospital
Tianjin Medical University General Hospital
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
To ensure the reliability of the research results, a study committee consisting of 5 members will be formed. The committee comprised a 2-member data safety monitoring committee and a 3-member clinical event review committee. Each reported ischemic event and bleeding event were assessed independently by three members of the clinical event adjudication committee. These committee members were blinded to the treatment group assignments. Any disagreements were resolved by a third member of the clinical events adjudication committee. All five committee members reviewed and resolved any discrepancies through consensus.
Intervention model description
cluster randomized controlled cohort study
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with unruptured intracranial aneurysms who received intracranial stenting, 2. Standard dualantiplatelet therapy for at least 5 days before stent implantation, 3. Patients aged 18-80, 4. on the day of registration patients with a Modified Rankin Scale lower than 2, 5. patients who agree and sign the consent form.
Exclusion criteria
1. Patients with recurrent aneurysms after interventional therapy or clipping therapy, 2. Patients with a history of allergy to aspirin, clopidogrel or ticagrelor, 3. Patients who used tirofiban prophylactically before surgery, 4. Possible active bleeding Patients with high blood pressure, such as symptomatic intracranial hemorrhage or active gastric ulcer; or patients with bleeding tendency or coagulation dysfunction, 5. Any abnormal platelet count (normal value is 100-300 × 10\^9/L), 6. Patients using anticoagulants, 7. Pregnant or lactating women, 8. Suffering from liver disease, kidney disease, congestive heart failure, malignant tumors and other malignant diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ischemic events | 30 days after stent implantation. | ischemic stroke, transient ischemic stroke (TIA), stent thrombosis |
Other
| Measure | Time frame | Description |
|---|---|---|
| Bleeding events | 30 days after stent implantation. | The primary safety endpoint was severe or life-threatening bleeding, moderate bleeding and minor bleeding, assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) classification. |
Countries
China
Outcome results
None listed