LTA-guided Antiplatelet Therapy in Interventional Treatment of Intracranial Aneurysms
Study Details
Study Description
Brief Summary
The use of intracranial stents broadens the indications for endovascular treatment of intracranial aneurysms and improves the cure rate, but it also increases the risk of postoperative ischemic complications in patients. The current standard dual antiplatelet regimen is considered to be an important method to reduce thrombotic events. However, some patients are resistant to antiplatelet drugs and have a high risk of thrombotic events. In actual clinical work, the standards for platelet function testing are not standardized, and the antiplatelet drug adjustment program also lacks norms and consensus. This study carried out a multi-center, prospective cluster randomized controlled study to explore whether the standardized antiplatelet adjustment program guided by LTA detection can reduce the incidence of ischemic events after stent implantation in patients with intracranial aneurysms. Further determine and correct the curative effect of the standardized use of antiplatelet drugs in the treatment of intracranial aneurysm stents, and finally formulate a set of standardized antiplatelet regimens for aneurysm stents.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: control group Continue to use the center's original antiplatelet regimen |
|
| Experimental: test group Use a standardized antiplatelet drug adjustment regimen based on LTA testing |
Drug: Adjustment of Antiplatelet Drugs
MPA-AA≥20%, give aspirin 200mg qd; MPA-ADP≥36.4%, give ticagrelor 60mg bid; MPA-ADP≥42.9%, give ticagrelor 60mg bid; MPA-ADP<20%, give Clopidogrel 37.5mg qd; The timing of drug adjustment should be at least 1 day before stent implantation, and the LTA results should be checked again after the drug adjustment, and the second antiplatelet drug adjustment should be performed for patients with drug overdose: *Aspirin overdose: Give 100mg, qd; *Overdose of ticagrelor: reduce to 30mg, bid;.
|
Outcome Measures
Primary Outcome Measures
- Ischemic events [30 days after stent implantation.]
ischemic stroke, TIA, stent thrombosis
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients with unruptured intracranial aneurysms who received intracranial stenting; ②Standard dual-antibody therapy for at least 5 days before stent implantation; ③Patients aged 18-80;
-
on the day of registration patients with a Modified Rankin Score lower than 2; ⑤patients who agree and sign the consent form;.-
Exclusion Criteria:
-
Patients with recurrent aneurysms after interventional therapy or clipping therapy; ②Patients with a history of allergy to aspirin, clopidogrel or ticagrelor;
-
Patients who used tilofiban prophylactically before surgery; ④Possible active bleeding Patients with high blood pressure, such as symptomatic intracranial hemorrhage or active gastric ulcer; or patients with bleeding tendency or coagulation dysfunction;
-
Any abnormal platelet count (normal value is 100-300 × 10^9/L);
-
Patients using Anticoagulants; ⑦ Pregnant or lactating women; ⑧ Suffering from liver disease, kidney disease, congestive heart failure, malignant tumors and other malignant diseases.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Neurosurgery, Beijing Tiantan Hospital. | Beijing | Beijing | China | 100070 |
Sponsors and Collaborators
- Beijing Tiantan Hospital
- 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
Investigators
- Principal Investigator: Xinjian Yang, MD, Beijing Tiantan Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Xinjian Yang