Drug-Eluting Stents, Percutaneous Coronary Intervention
Conditions
Brief 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.
Detailed 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.
Interventions
DRUG3 months DAPT
Subjects will continue DAPT with P2Y12 inhibitors and Aspirin (ASA) up to 90 days, after which patients will continue on monotherapy with ASA only, unless contraindications for ASA emerge.
DRUG12 months DAPT
Subjects will continue DAPT with P2Y12 inhibitors and Aspirin (ASA) up to 360 days, after which patients will continue on monotherapy with ASA only, unless contraindications for ASA emerge.
Sponsors
Shanghai MicroPort Medical (Group) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria: * Age ≥ 18 years; * Subjects (or legal guardians) understand the testing requirements and procedures, and provide written informed consent; * Subjects with symptomatic coronary artery disease or confirmed asymptomatic ischemia; * Target lesion should be new lesion with visually estimated reference diameter ≥2.5 mm and ≤4.0 mm in autologous coronary artery; * Subjects willing to accept PCI therapy and to implant Firehawk™ stent only; * Left ventricular ejection fraction (LVEF) ≥ 30%; * Subjects willing to accept the trial plan calls for all subsequent evaluations. Angiographic Inclusion Criteria: * Target lesions must be new and have a visually estimated reference diameter ≥2.5 mm and ≤4.0 mm in autologous coronary artery; * No limitations in target lesion length and number; * The first target lesion must be able to successfully expand and implant Firehawk™ stent. Clinical
Exclusion criteria
* Subjects with ST-segment elevation myocardial infarction: * Subjects having an organ transplant or waiting for an organ transplant * Subjects receiving chemotherapy or going to receive a chemotherapy within 30 days after PCI * Subjects undergoing chronic (over 72 hours) anticoagulant therapy (such as heparin and coumarin) other than acute coronary syndrome * Subjects with abnormal counts of platelet and white blood cell (WBC) (investigator assess clinical significance combine normal reference range of laboratory) * Subjects with confirmed or suspected liver disease, including hepatitis lab results * Subjects with elevated serum creatinine level \>3.0mg/dL or undergoing dialysis therapy * Subjects with active peptic ulcer, active gastrointestinal (GI) bleeding or other bleeding diathesis or coagulopathy, or refused a blood transfusion * Subjects with cerebral vascular accident (CVA) or transient ischemic attack (TIA) in the past 6 months, or with permanent nerve defects * Subjects undergoing any PCI treatment in target vessels within 12 months prior to baseline * Subjects planned to undergo PCI or CABG within 18 months after the baseline PCI * Subjects with a history of any coronary endovascular brachytherapy treatment previously * Subjects associated with drugs allergy (such as sirolimus, or structure-related compounds fluorinated polymers, thienopyridine or aspirin) * Subjects being suffered from other serious illness (such as cancer, congestive heart failure), which may cause drop in life expectancy to less than 18 months * Subjects with a history of drug abuse (such as alcohol, cocaine, heroin, etc.) * Subject planned to undergo any operations that may lead to confuse with the programme * Subjects participating in another study of drug or medical device which did not meet its primary endpoint * Subjects planned to pregnant within 18 months after baseline * Pregnant or breastfeeding women Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Net Adverse Clinical and Cerebral Events (NACCE) | At 18 months after index procedure | A composite of all-cause death, MI, cerebral vascular accident (CVA) and major bleeding at 18 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost-Effectiveness Ratio (CER) | At 18 months after index procedure | CER = \[total medical care costs of anti-platelet therapy\] / \[number of participants without net adverse clinical and cerebral events (NACCE)\] |
Other
| Measure | Time frame | Description |
|---|---|---|
| Net Adverse Clinical and Cerebral Events (NACCE) | In hospital and at 30 days, 3, 6, 12, 24 and 36 months after index procedure. | — |
| Major Adverse Cardiac and Cerebral Events (MACCE) | In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure. | — |
| Stent Thrombosis (per ARC definition) | In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure. | the definite and probable stent thrombosis |
| Target Vessel Revascularization (TVR) | In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure. | — |
| Target Lesion Revascularization (TLR) | In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure. | — |
| Target Vessel Failure (TVF) | In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure. | — |
| Major bleeding (ARC definition and GUSTO definition) | In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure. | — |
| Myocardial Infarction (MI,including Q-wave MI and non Q-wave MI) | In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure. | — |
| Cardiac Death/ All Myocardial Infarction | In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure. | — |
| Procedural Success | At time of procedure up to 7 days in hospital | — |
| Minimal Lumen Diameter (MLD)（In-device, in-segment, proximal 5 mm and distal 5 mm) | Instantly after index procedure | — |
| The Immediate Lumen Gain | Instantly after index procedure | — |
| Target Lesion Failure (TLF) | In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure. | — |
| Death (All cause, Cardiac, Non-cardiac) | In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure. | — |
Countries
China
Contacts
Primary ContactMing Zheng, MD
Outcome results
None listed