NCT03287167

Comparison One vs Six Months of Dual Antiplatelet Therapy After Implanted Firehawk TM Stent in High Bleeding Risk Patients With Coronary Artery Disease

A Prospective, Double -Blind ,Multi-center,Randomized Controled Trial of Comparison One vs Six Months of Dual Antiplatelet Therapy After Implanted Sirolimus- Eluting Stent With Abluminal Grooves Containing A Biodegradable Polymer (FirehawkTM Stent ) in High Bleeding Risk Patients With Coronary Artery Disease

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,720 (estimated)
• Sponsor: Shanghai MicroPort Medical (Group) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to assess the clinical non-inferiority of 1 month (short-term) vs 6 months (long-term) of dual anti-platelet therapy in patients undergoing percutaneous intervention implanted sirolimus -eluting stent with abluminal grooves containing a biodegradable polymer in High Bleeding Risk patients with coronary artery disease.

Detailed description

This is a prospective, double -blind,multi-center,randomized controlled trial. Approximately 1,720 subjects in high bleeding risk with coronary artery disease will be enrolled in no more than 40 research centers in China. All participants met the inclusion criteria will be 1:1 randomized to 1 month or 6months of DAPT after implanting Firehawk™ coronary stent. Clinical follow-up will be carried out at 30 days, 6 months, 12 months, 2 years after index procedure.The primary study endpoint is Net Adverse Clinical and Cerebral Events (NACCE), a composite of all-cause death, myocardial infarction (MI), cerebral vascular accident (CVA) and major bleeding (\[BARC\] definition) at 12 months. Subjects that complete of 12 months follow-up will be regarded as having completed the primary endpoint. The secondary study endpoints contain cost-effectiveness at 12 months, ARC defined stent thrombosis (ST) ; NACCE ;major adverse cardiovascular events (MACE),major adverse cardiovascular and cerebral events (MACCE),target lesion revascularization (TLR),target vessel failure(TVF) , major bleeding at 30 days,6,12 and 24 months of follow-up.

Conditions

• Coronary Disease
• Drug Eluting Stent
• Percutaneous Coronary Intervention
• Dual Antiplatelet Therapy

Interventions

Type	Name	Description
DRUG	1 month DAPT	Subjects will continue DAPT with clopidogrel and Aspirin (ASA) up to 1 month, after which patients will be given ASA and placebo in next 5 months and then continue on monotherapy with ASA only, unless contraindications for ASA emerge.
DRUG	6 months DAPT	Subjects will continue DAPT with clopidogrel and Aspirin (ASA) up to 6 months, after which patients will continue on monotherapy with ASA only, unless contraindications for ASA emerge.

Timeline

• Start date: 2019-06-01
• Primary completion: 2021-07-01
• Completion: 2023-07-30
• First posted: 2017-09-19
• Last updated: 2020-09-09

Locations

1 site across 1 country: China