Coronary Disease Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 1720 |
Est. completion date | July 30, 2023 |
Est. primary completion date | July 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
General Inclusion Criteria: - Age = 18 years; - Subjects (or legal guardians) understand the testing requirements and procedures, and provide written informed consent; - Subjects could undergo percutaneous coronary intervention (PCI); - Subjects have symptomatic coronary artery disease or have confirmed asymptomatic ischemia; - Subjects are eligible candidates for coronary artery bypass graft surgery (CABG); - Left ventricular ejection fraction (LVEF) within 60 days = 30%; - Subjects were willing to accept the trial plan calls for all subsequent evaluations; - Subjects can endure 6 months dual anti-platelet therapy, and met one or more criteria as the following: 1.Age = 75years; 2.Subjects with hemoglobin<10g/dL, or subjects received transfusion therapy 4 weeks ago; 3.Subjects with renal insufficiency (eGFR < 60 ml / min); 4. Subjects with HAS-BLED score =3.0; 5.Femal patients with acute cononary syndrome; 6.BMI < 18.5 Kg/M2; 7.Subjects with congestive heart failure and with LVEF30%-50%; 8.Subjects had a history of hospitalization due to bleeding; 9.Subjects with thrombocytopenia (platelet < 100,000 / mm3); 10.Subjects had a histroy of intracranial hemorrhage; 11.Subjects had a histroy of intracranial ischemia stroke in 6 months; 12.Subjects plan to receive non-steroidal anti-inflammatory or steroid treatment for more than 30 days after the baseline PCI; 14.Subjects were expected to receive additional treatment after PCI and cannot undergo long-term DAPT therapy; 15.Subjects had a history of stomach ulcers or active ulcers. Angiographic Inclusion Criteria - Target lesions must be new and have a visually estimated reference diameter =2.25 mm and =4.0 mm in autologous coronary artery; - Target lesions must be moderate-severe calcification; - No limitations in target lesion length and number, and the number of implanted stents is less than 4; - ALL target lesion must be able to successfully expand and implant Firehawk™ stent. Clinical Exclusion Criteria: - Subjects recently suffer from MI (within 4 week) and ECG changes/clinical symptoms consistent with AMI, or accompanied with increased cardiac biomarkers (CK-MB, CK, TNT or TNI) and at least one of the following : 1. CK-MB> 3ULN, regardless of the value of total CK; 2. If CK-MB or CK was not detected, but cTN> 1ULN, and at least one of the following: 1. Ischemic symptoms and ECG changes of new ischemia; 2. Development of pathologic Q waves in the ECG; 3. Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. - Subject had Re-MI before randomized; - Subject with hemodynamic instability (Killip class IV); - Subjects were detected ventricular aneurysm greater than 3.0*2.0cm or intraventricular thrombosis by cardiac ultrasonography in 30 days; - Subjects with Life-threatening arrhythmias; - Subjects were expected to receive oral anticoagulation therapy after the baseline PCI; - Subjects cannot endure dual anti-platelet therapy for 1 month; - Subjects with mechanical complications after myocardial infarction; - Subjects had an organ transplant or are waiting for an organ transplant; - Subjects are receiving chemotherapy or will receive a chemotherapy within 30 days after PCI; - Subjects with abnormal counts of white blood cell (WBC); - Subjects with verified or suspected acute liver disease, including lab results of acute liver disease; - Subjects had permanent neurological diseases in the past 6 months; - Subjects had any PCI (such as balloon angioplasty, stent, cutting balloon) treatment in target vessels within 12 months prior to baseline; - Non-target vessel had been implanted non-research stent 5 months ago before the baselin PCI. - Subjects plan to undergo PCI or CABG within 1 year after the baseline PCI; - Subjects have any coronary endovascular brachytherapy treatment previously; - Subjects associated with drugs allergy (such as sirolimus, or structure-related compounds fluorinated polymers, thiophenepyridine or aspirin); - Subjects are suffering from other serious illness (such as cancer, congestive heart failure), which may cause drop in life expectancy to less than 12 months; - Subjects are currently abusing drugs (such as alcohol, cocaine, heroin, etc); - Subject plan to undergo any operations that may lead to confuse with the programme; - Subjects were participating in another study of drug or medical device which did not meet its primary endpoint; - Subjects plan to pregnant within 12 months after baseline; - Subjects are pregnant or breastfeeding women. Angiographic Exclusion Criteria (visual estimate): - Target lesions with the following criteria: left main, saphenous vein grafts or arterial grafts, via saphenous vein grafts or arterial graft, more than 4 stents have been implanted and in-stent sestenosis; - Subjects with unprotected left main coronary artery disease (diameter stenosis >50%); - Subjects have a protected left main coronary artery disease (diameter stenosis> 50% and left coronary artery bypass surgery), as well as target lesions located in the LAD and LCX; - Subjects with other lesions of clinical significance, may be need intervention within 12 months after baseline. |
Country | Name | City | State |
---|---|---|---|
China | The General Hospital of Shenyang Military | Shenyang | Liaoning |
Lead Sponsor | Collaborator |
---|---|
Shanghai MicroPort Medical (Group) Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Cost-Effectiveness Ratio (CER) | CER = [total medical care costs of anti-platelet therapy] / [number of participants without net adverse clinical and cerebral events (NACCE)] | At 12 months after index procedure | |
Primary | Net Adverse Clinical and Cerebral Events (NACCE) | A composite of all-cause death, MI, cerebral vascular accident (CVA) and major bleeding at 18 months | At 12 months after index procedure | |
Secondary | Target Vessel Revascularization (TVR) | In hospital and at 30 days,6, 12 and 24 months after index procedure | ||
Secondary | Target lesion Revascularization (TLR) | In hospital and at 30 days,6, 12 and 24 months after index procedure | ||
Secondary | Target Vessel Failure (TVF) | In hospital and at 30 days,6, 12 and 24 months after index procedure | ||
Secondary | Target Lesion Failure (TLF) | In hospital and at 30 days,6, 12 and 24 months after index procedure | ||
Secondary | Stent Thrombosis (per ARC definition) | the definite and probable stent thrombosis | In hospital and at 30 days,6, 12 and 24 months after index procedure | |
Secondary | Major Adverse Cardiac and Cerebral Events(MACCE) | In hospital and at 30 days,6, 12 and 24 months after index procedure | ||
Secondary | Net Adverse Clinical and Cerebral Events (NACCE) | In hospital and at 30 days,6, 12 and 24 months after index procedure | ||
Secondary | Myocardial Infarction (MI,including Q-wave MI and non Q-wave MI) | In hospital and at 30 days,6, 12 and 24 months after index procedure | ||
Secondary | Death (All cause, Cardiac, Non-cardiac) | In hospital and at 30 days,6, 12 and 24 months after index procedure | ||
Secondary | Cardiac Death | In hospital and at 30 days,6, 12 and 24 months after index procedure | ||
Secondary | Non-Cardiac Death | In hospital and at 30 days,6, 12 and 24 months after index procedure | ||
Secondary | Major Bleeding | [BARC] definition | In hospital and at 30 days,6, 12 and 24 months after index procedure |
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