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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Tirofiban treatment for patients with high-risk cerebrovascular events

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.