Clinical Trials Logo

Clinical Trial Summary

This study is a prospective,multi-center, open-label, randomized controlled clinical trial,aims to assess the clinical noninferiority of 3 months (short-term) vs 12 months (long-term) of Dual Anti-Platelet Therapy (DAPT) in patients undergoing percutaneous coronary intervention implanted sirolimus target- eluting stent with abluminal grooves containing a biodegradable polymer (Firehawk™ stent). All participants met the inclusion criteria begin taking aspirin and open-label thienopyridine therapy before index procedure, and will be 1:1 randomized to 3 months or 12 month of DAPT at index procedure.

Clinical Trial Description

This study will recruit 2,446 subjects with stable coronary artery disease in no more than 40 research centers in China. All participants met the inclusion criteria will be 1:1 randomized to 3 months or 12 month of DAPT after implanting Firehawk™ coronary stent.Clinical follow-up will be carried out at 30 days, 3 months, 6 months, 12 months, 18 months, 2 years and 3 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 (academic research consortium [ARC] definition and GUSTO definition) at 18 months. Subjects that complete of 18 months follow-up will be regarded as having completed the primary endpoint. The secondary study endpoints contain ARC defined stent thrombosis (ST) at all study time-points; NACCE at 30 days,6,12,24 and 36 months of follow-up;major adverse cardiovascular events (MACE),major adverse cardiovascular and cerebral events (MACCE),target lesion revascularization (TLR),target lesion failure(TLF),ST at 30 days,6,12 ,18,24 and 36 months of follow-up; major bleeding at 1, 3, 6, 12 ,18,24 and 36 months of follow up; as well as cost-effective at 18 months of follow-up. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03008083
Study type Interventional
Source Shanghai MicroPort Medical (Group) Co., Ltd.
Contact Ming Zheng, MD
Phone (86)(10)66513642-6229
Email [email protected]
Status Recruiting
Phase Phase 4
Start date January 10, 2019
Completion date October 2022

See also
  Status Clinical Trial Phase
Recruiting NCT03959072 - Cardiac Cath Lab Staff Radiation Exposure
Not yet recruiting NCT04566497 - Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up. N/A
Recruiting NCT03378934 - Anti-platelet Effect of Berberine in Patients After Percutaneous Coronary Intervention Phase 4
Not yet recruiting NCT04928092 - A Zero Acute Kidney Injury Strategy for Percutaneous Coronary Intervention in Patients With ChronicKidney Disease
Not yet recruiting NCT04043091 - Coronary Angiography in Critically Ill Patients With Type II Myocardial Infarction Phase 3
Recruiting NCT03085823 - The All-comers Sirolimus-coated Balloon European Registry
Completed NCT02837744 - Studying Hemostatic Effect of Axiostat® Dressing on Radial Access After Percutaneous Procedure
Completed NCT02044146 - A Pharmacodynamic Study of a Personalized Strategy for P2Y12 Inhibition Versus Ticagrelor in Reducing Ischemic and Bleeding Risk Phase 2/Phase 3
Completed NCT03131271 - Effect of Ice Bag Application to Femoral Region on Pain in Patients Undergoing Percutaneous Coronary Intervention N/A
Completed NCT01135667 - Prasugrel Versus Double Dose Clopidogrel to Treat Clopidogrel Low-responsiveness After PCI Phase 4
Completed NCT01156571 - A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention (PCI) (CHAMPION PHOENIX) Phase 3
Unknown status NCT00751491 - Clopidogrel Versus Adenosin in Non Urgent Percutaneous Coronary Intervention (PCI) Phase 3
Completed NCT00725868 - Blood Endothelium Biomarkers to Predict Major Adverse Cardiovascular Events After Percutaneous Coronary Intervention N/A
Active, not recruiting NCT03708588 - Chewed Versus Integral Pill of Ticagrelor Phase 4
Recruiting NCT04163393 - R-One Efficiency For PCI Evolution With Robotic Assistance N/A
Completed NCT03776266 - The Long-term Clinical Outcomes and Patterns of Transfusion in PCI Patients: Retrospective Cohort Study
Recruiting NCT03451617 - Alpine vs. Xpedition: Evaluation of Stent Delivery System N/A
Recruiting NCT02276846 - Palpitate-Eluting Balloon Angioplasty in the Treatment of Coronary Bifurcation Lesion Evaluated by OCT N/A
Not yet recruiting NCT02269449 - Radial Artery Patency and Bleeding, Efficacy, Adverse evenT Trial N/A
Completed NCT02327741 - Efficacy of Long Term Plavix Therapy Post Angioplasty N/A