Tirofiban for Reduction of Thromboembolic Events in Endovascular Unruptured Aneurysm Repair

Thromboembolic Events Clinical Trial

— TEAR  

Official title:

Prophylactic Administration of Tirofiban for Preventing Thromboembolic Events in Stent-assisted Coiling and Flow Diversion Treatments of Unruptured Intracranial Aneurysms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06238115
• Other study ID #: CSA2022KY009
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: March 4, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: March 2024
• Source: Beijing Tiantan Hospital
• Contact: Qianmei Jiang
• Phone: 13882701231
• Email: 13882701231[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To explore whether administering tirofiban in stent-assisted coiling/flow diverting treatments for participants with unruptured intracranial aneurysms can reduce new ischemic lesions on postoperative DWI sequences compared to conventional dual antiplatelet therapy.

Description:

This is a single-center, open-label, assessor-blinded randomized controlled trial. Participants with stent-assisted coiling/flow diverting for unruptured intracranial aneurysms will be enrolled and randomized into two groups: Tirofiban group-after femoral artery puncture, initial infusion of 0.4μg/kg body weight/minute over 30 minutes, followed by a continuous infusion of 0.1μg/kg body weight/minute for 24 hours. Meanwhile, routine dual antiplatelet therapy (aspirin 100 mg/day, clopidogrel 75 mg/day) will be administered. Placebo group-100 mg/day aspirin and 75 mg/day clopidogrel. The primary effectiveness endpoint is the numbers and volumes of ischemic lesions on diffusion weighted imaging (DWI) within 48 hours after procedure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: June 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Ages 18-80.

2. Participants with unruptured cerebral aneurysms eligible for stent-assisted coiling or flow diversion devices.

3. Completement of preoperative antiplatelet preparation.

4. Signed informed consent.

Exclusion Criteria:

1. Abnormal platelet count (normal reference is 100-300×10^9/L).

2. Allergy to study drugs and anesthetics.

3. Contradictory to MRI examination.

4. Known history of intracranial tumor, arteriovenous malformation, arteriovenous fistula, venous sinus thrombosis, hereditary cerebral small vessel disease, peripheral hemangioma (e.g., aortic aneurysm, limb vascular aneurysm).

5. Known history of cerebral parenchymal hemorrhage, subarachnoid hemorrhage, cerebral infarction, transient ischemic attack, or gastrointestinal bleeding within 6 months.

6. Clear indications for anticoagulation (presumed cardiac source of embolus, e.g., atrial fibrillation, prosthetic cardiac valves known or suspected endocarditis).

7. Antiplatelet drug (exclude aspirin and clopidogrel) being taken within 72 hours; anticoagulant drug (including heparin or oral anticoagulants) being taken within 10 days;

8. Participants with recurrent aneurysms who have received neurointerventional treatment.

9. Inability to follow endovascular procedures due to anatomical difficulties.

10. Severe renal (creatinine exceeding 1.5 times of the upper limit of normal range) or hepatic (ALT or AST > twice the upper limit of normal range) insufficiency.

11. Severe heart failure (NYHA classes III and IV) or severe arrhythmias, including sick sinus syndrome, severe atrioventricular block, and bradycardia-related syncope.

12. Pregnant.

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Stent-assisted Coiling
• Thromboembolic Events
• Thromboembolism
• Unruptured Intracranial Aneurysm

Intervention

Drug:
• Tirofiban
Initial infusion of 0.4µg/kg body weight/minute over 30 minutes, followed by a continuous infusion of 0.1µg/kg body weight/minute for 24 hours.
• aspirin, clopidogrel
aspirin 100 mg/day, clopidogrel 75 mg/day

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Moderate and severe bleeding events according to the GUSTO criteria within 48-hour after procedure.		at postoperative 48-hour
Other	Moderate and severe bleeding events according to the GUSTO criteria within 30-day after procedure.		at postoperative 30-day
Other	All bleeding events (severe/moderate bleeding and intracranial hemorrhage) within 48-hour and 30-day after procedure.		at postoperative 48-hour and 30-day
Other	Symptomatic intracranial hemorrhage according to the ECASSIII criteria within 48-hour and 30-day after procedure.		at postoperative 48-hour and 30-day
Other	Total mortality within 48-hour and 30-day after procedure.		at postoperative 48-hour and 30-day
Other	Adverse events/Severe adverse events reported by investigators within 48-hour and 30-day after procedure.		at postoperative 48-hour and 30-day
Primary	The volumes of ischemic lesions on diffusion weighted imaging within 48 hours after procedure.		within 48 hours after procedure
Primary	The numbers of ischemic lesions on diffusion weighted imaging within 48 hours after procedure.		within 48 hours after procedure
Secondary	Any new stroke events (ischemic stroke or hemorrhagic stroke) within 48-hour and 30-day after procedure.		at postoperative 48-hour and 30-day
Secondary	Incidence of ischemic stroke within 48-hour and 30-day after procedure.		at postoperative 48-hour and 30-day
Secondary	Incidence of transient ischemic attack within 48-hour and 30-day after procedure.		at postoperative 48-hour and 30-day
Secondary	Incidence of ischemic stroke and transient ischemic attack within 48-hour and 30-day after procedure.		at postoperative 48-hour and 30-day
Secondary	Disabling stroke within 30-day after procedure.	Disabling stroke is defined as modified Rankin Scale score >1. The modified Rankin Scale score ranges from 0 to 6, and the higher the score, the greater the degree of disability.	at postoperative 30-day