Comparing 3 vs 6 months of dual anti-platelet therapy after stent implantation

A Prospective, Multicenter, Open-label, Randomized Controlled Trial of 3-month Versus 6-month Dual Antiplatelet Therapy After Implantation of NOVA Intracranial Sirolimus-eluting Stent System

This study is testing whether taking dual anti-platelet therapy for 3 months is just as safe and effective as taking it for 6 months after getting a stent for narrowed brain arteries.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 478 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Sino Medical Sciences Technology Inc. (Industry-sponsored)
• Locations: 1 site (Ha'erbin)
• Trial ID: NCT06857045 on ClinicalTrials.gov

What this trial studies

This clinical trial is a multicenter, open-label, randomized controlled trial designed to evaluate the non-inferiority of 3 months versus 6 months of dual anti-platelet therapy (DAPT) in patients who have undergone implantation of the NOVA intracranial sirolimus-eluting stent. A total of 478 subjects with symptomatic intracranial artery stenosis will be recruited and randomly assigned to receive either short-term or long-term DAPT. Participants will be followed up at various intervals over a period of five years to assess the primary endpoint, which includes any stroke, death, and major bleeding events. The study aims to provide insights into the optimal duration of DAPT following stent implantation.

Who should consider this trial

Good fit: Ideal candidates for this study are males and females aged 35 to 80 with symptomatic intracranial arteriosclerosis stenosis and significant artery stenosis confirmed by imaging.

Not a fit: Patients with recent major surgeries, acute hemorrhagic strokes, or non-atherosclerotic vascular diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help determine the safest and most effective duration of dual anti-platelet therapy for patients with intracranial artery stenosis, potentially reducing the risk of complications.

How similar studies have performed: Other studies have explored dual anti-platelet therapy durations, but this specific comparison of 3 vs 6 months in the context of intracranial stenting is relatively novel.

Eligibility criteria

Inclusion criteria

1. Males or females between 35 and 80 years of age.
2. Symptomatic intracranial arteriosclerosis stenosis with reference diameter 2.25-4.00mm;.
3. Intracranial artery stenosis (≥70%) conformed by DSA.
4. Subjects who voluntarily participate in the study and sign informed consent form.

Exclusion Criteria:

1. Subjects who have surgery within previous 30 days or plan to perform major surgery in the next 90 days (surgery grade 3 and above).
2. Subjects of acute hemorrhagic stroke within 3 months.
3. Disabling stroke with a baseline mRS score ≥3.
4. Lesion artery with severe calcification and close neighbour stenosis.
5. Non-atherosclerotic diseases (e.g. arterial dissection, Moya Moya disease, vascular inflammatory lesions caused by infection, autoimmune diseases, post-irradiation, postpartum status; developmental or genetic abnormalities such as fibromuscular dysplasia, sickle cell anemia, suspected vasospasm).
6. The ischaemic event that is highly suspected to be due to vascular embolism from an extracranial arterial segment such as ipsilateral neck/chest arterial occlusion) or cardio embolism such as atrial fibrillation, mitral stenosis, left ventricular thrombus, patent foramen ovale, myocardial infarction within 6 weeks, etc.
7. More than 50% stenosis of the supplying artery of the lesion artery: 1) MCA severe stenosis (lesion artery) with more than 50% stenosis of ipsilateral ICA (supplying artery). 2) Basilar artery severe stenosis (lesion artery) with more than 50% stenosis of dominant VA (supplying artery) stenosis.
8. Accompanied by intracranial tumours or intracranial arteriovenous malformations.
9. The patient who is allergy response to heparin, aspirin, clopidogrel, rapamycin, contrast agents, anaesthetics, or drug eluted stent components.
10. Women who are pregnant or lactating.
11. Due to cognitive or emotional disorders or mental illness, the patient who cannot finish the follow-up.
12. Investigators consider the patient who is not suitable for enrolling in the present trial.

Where this trial is running

Ha'erbin

• The Fourth Affiliated Hospital of China Medical University — Ha'erbin, China (Recruiting)

Study contacts

• Principal investigator: Lianbo Gao — The Fourth Affiliated Hospital of China Medical University

Conditions Intracranial Arteriosclerosis; Intracranial Artery Stenosis; Drug-Eluting Stents; intracranial drug-eluting stent; symptomatic intracranial artery stenosis