Guided Antiplatelet Therapy in Interventional Treatment of Intracranial Aneurysms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

590 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-04

Study Completion Date

2023-10-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Intracranial Aneurysm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

cluster randomized controlled cohort study

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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control group

Continue to use the center's original antiplatelet regimen: oral aspirin 100 mg and clopidogrel 75 mg daily

Group Type NO_INTERVENTION

No interventions assigned to this group

test group

Use a guided antiplatelet regimen based on LTA testing

Group Type EXPERIMENTAL

Adjustment of Antiplatelet Drugs

Intervention Type DRUG

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.

Interventions

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Adjustment 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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No