Optimized Antiplatelet Therapy in Patients With CHD After Implantation of NeoVas™ BRS System

Official title

Evaluate the Safety and Efficacy of Optimized Antiplatelet Therapy in Patients With Coronary Heart Disease After Implantation of NeoVas™ Bioabsorbable Coronary Artery Rapamycin-eluting Stent System.

Overview

This study is designed to verify the safety and efficacy of Lepu® NeoVas™ Bioabsorbable Coronary Artery Rapamycin-eluting Stent System combined with different antiplatelet therapies in the treatment of coronary heart disease.

Detailed description

A total of 2150 subjects are planned to be enrolled in this trial. Subjects meeting the inclusion criteria and without exclusion criteria are implanted with NeoVas™ stents and randomly assigned to the experimental group and the control group in a 1:1 ratio. Patients in both groups will receive aspirin in combination with a P2Y12 receptor antagonist in the first year after PCI (either clopidogrel or ticagrelor will be selected by investigators according to the degree of ischemia). Aspirin will be discontinued one year after surgery and clopidogrel will be continued until 5 years after surgery in the experimental group. The control group will continue to take dual antiplatelet (DAPT) drugs, including aspirin and clopidogrel, for 2 more years; then aspirin will be used alone from the 4th year to the 5th year.

Subjects will be followed up at 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years after surgery to observe whether the net adverse clinical events (NACEs) and other end points occur or not.

Interventions

• Drug Single anti-platelet therapy
  Aspirin in combination with a P2Y12 receptor antagonist (either clopidogrel or ticagrelor will be selected by investigators according to the degree of ischemia) in the first year after PCI. Aspirin will be discontinued one year after surgery and clopidogrel will be continued until 5 years after surgery.
• Drug Dual anti-platelet therapy
  Aspirin in combination with a P2Y12 receptor antagonist (either clopidogrel or ticagrelor will be selected by investigators according to the degree of ischemia) in the first year after PCI. Patients continue to take dual antiplatelet (DAPT) drugs, including aspirin and clopidogrel, for 2 more years; then aspirin will be used alone from the 4th year to the 5th year.

Primary outcome measures

• Net adverse clinical event (NACE) [Time frame: 3 years]

Secondary outcome measures (11)

• Target lesion failure (TLF) [Time frame: 3 years]
• Comparison of net adverse clinical events [Time frame: 30 days, 6 months, 1 year, 2 years, 4 years, and 5 years]
• Bleeding events of grade 3 and 5 as defined by BARC [Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years]
• Bleeding events of grade 2, 3 and 5 as defined by BARC [Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years]
• Bleeding events of grade 1, 2, 3 and 5 as defined by BARC [Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years]
• Comparison of target lesion failures [Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years]
• Patient-oriented composite endpoint (PoCE) [Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years]
• Ischemic-driven target lesion revascularization (iTLR) [Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years]
• Ischemic-driven target vessel revascularization (iTVR) [Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years]
• All cardiac revascularization [Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years]
• Two types of stent thrombosis events as defined by BRS_ARC2 [Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years]

Eligibility criteria

Inclusion criteria

• Age 18 or above, male or non-pregnant female.
• Evidence of myocardial ischemia (e.g., stable angina, unstable angina, medium-low risk NSTEMI, STEMI with onset more than 1 week, old myocardial infarction or asymptomatic myocardial ischemia), and suitable for PCI surgery.
• The target lesion is in-situ coronary artery lesion, the total length of single lesion is no more than 40mm (the total length of stent is no more than 48mm), and the diameter of the target lesion is between 2.75mm and 3.75mm (visual measurement).
• The diameter stenosis of target lesion is ≥70% in visual (or ≥50% with clinical evidence of myocardial ischemia in that range), and the TIMI blood flow is greater than grade 1.
• The stent with diameter more than 3.0mm is allowed to overlap with another stent once, the overlapping methods could be edge to edge or at most 1mm overlap. The total number of stents per patient is no more than 4, with a maximum of 2 stents per vessel (the 2.75mm diameter stent is not allowed to overlap).
• Patient with indications for coronary artery bypass surgery.
• Aspirin and clopidogrel could be used continuously during the study.
• Patient who can understand the purpose of this trial, is willing to participate in the trial and to conduct clinical follow-up as required by the study protocol.

Exclusion criteria

• Acute ST-segment elevation myocardial infarction within 1 week.
• Left main coronary artery disease, branch vessel diameter≥2.0mm, three-vessel coronary artery disease and bridge vessel disease; visible thrombus in the target vessel.
• Severe distortion, severe calcification that cannot be successfully predilated, and other lesions that are not suitable for stent delivery and deployment.
• Intra-stent restenosis.
• Severe heart failure (NYHA≥III or left ventricular ejection fraction<35%).
• Severe renal insufficiency, eGFR<30ml/min/1.73m2 or serum creatinine>2.5mg/dL (221μmol/L).
• Patients with bleeding tendency, active gastrointestinal ulcer, history of cerebral hemorrhage or subarachnoid hemorrhage, history of stroke within half a year, fundus hemorrhage affecting vision, antiplatelet agents and anticoagulant treatment contraindications who cannot receive antithrombotic therapy.
• Patients requiring long-term oral anticoagulants during the study period.
• Patients who are pregnant, breastfeeding, or planning to become pregnant during the study period.
• Patients with malignancies, organ transplants, or drug addiction that can seriously affect study compliance.
• Patients with contraindications to aspirin, clopidogrel or ticagrelor.
• Known allergy to aspirin, clopidogrel, ticagrelor, heparin, contrast agent, polylactic acid polymer and rapamycin.
• Thrombosis occurred during previous clopidogrel treatment.
• Life expectancy is less than 36 months.
• Participated in clinical trials of other drugs or medical devices before enrollment and failed to meet the time limit of the primary end point.
• Patients who will have elective surgery within a year and need to discontinue aspirin, clopidogrel or ticagrelor.
• Subjects are deemed unsuitable for enrollment by investigators.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 114 centers

• The First Affiliated Hospital of Bengbu Medical College — Bengbu
• The First Affiliated Hospital with Anhui Medical University — Hefei
• The First Affiliated Hospital of Wannan Medical College — Wuhu
• Peking Union Medical College Hospital — Beijing
• Beijing Chaoyang Hospital, Capital Medical University — Beijing
• Beijing Anzhen Hospital, Capital Medical University-12 Ward — Beijing
• Beijing Anzhen Hospital, Capital Medical University-28 Ward — Beijing
• Beijing Anzhen Hospital, Capital Medical University-33 Ward — Beijing
• … and 106 more centers

Identifiers

NCT: NCT04995159 · OPT-BRS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗