Clinical trial NCT03008083: Comparison Three vs Twelve Months of Dual Anti-Platelet Therapy After Stent Implantation
Official title: A Prospective Multi-center Open-label Controlled Trial of Comparison 3 vs 12 Months of Dual Anti-Platelet Therapy After Implantation of Firehawk Sirolimus Target- Eluting Stent in Patients With Stable Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Drug-Eluting Stents
Percutaneous Coronary Intervention
Lead sponsor: Shanghai MicroPort Medical (Group) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-01-02
Enrollment: 2446
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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 Exclusion Criteria:

* Target lesions with the following criteria: left main, saphenous vein grafts or arterial grafts, via saphenous vein grafts or arterial graft, and in-stent restenosis;
* Subjects with unprotected left main coronary artery disease (diameter stenosis \>50%);
* Protected left main coronary artery disease(diameter stenosis \>50% and undergoing CABG)with target lesions located in left anterior descending artery and left circumflex artery;
* Additional lesions of clinical significance possibly needing interventional within 18 months after enrollment..

Primary outcomes:
measure: Net Adverse Clinical and Cerebral Events (NACCE)
timeFrame: At 18 months after index procedure
Secondary outcomes:
measure: Cost-Effectiveness Ratio (CER)
timeFrame: At 18 months after index procedure
Other outcomes:
measure: Net Adverse Clinical and Cerebral Events (NACCE)
timeFrame: In hospital and at 30 days, 3, 6, 12, 24 and 36 months after index procedure.
measure: Major Adverse Cardiac and Cerebral Events (MACCE)
timeFrame: In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure.
measure: Stent Thrombosis (per ARC definition)
timeFrame: In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure.
measure: Target Vessel Revascularization (TVR)
timeFrame: In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure.
measure: Target Lesion Revascularization (TLR)
timeFrame: In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure.
measure: Target Vessel Failure (TVF)
timeFrame: In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure.
measure: Target Lesion Failure (TLF)
timeFrame: In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure.
measure: Myocardial Infarction (MI,including Q-wave MI and non Q-wave MI)
timeFrame: In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure.
measure: Major bleeding (ARC definition and GUSTO definition)
timeFrame: In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure.
measure: Death (All cause, Cardiac, Non-cardiac)
timeFrame: In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure.
measure: Cardiac Death/ All Myocardial Infarction
timeFrame: In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure.
measure: Procedural Success
timeFrame: At time of procedure up to 7 days in hospital
measure: Minimal Lumen Diameter (MLD)（In-device, in-segment, proximal 5 mm and distal 5 mm)
timeFrame: Instantly after index procedure
measure: The Immediate Lumen Gain
timeFrame: Instantly after index procedure
Locations:
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
Study officials:
affiliation: Affiliated Zhongshan Hospital of Fudan University
name: Junbo Ge, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yang H, Zhang F, Yang J, Zheng M, Cao R, Dai Y, Li C, Yao K, Qian J, Ge J; TARGET DAPT trial investigators. Prospective multicentre open-label randomised controlled trial of 3-month versus 12-month dual antiplatelet therapy after implantation of the new generation biodegradable polymer sirolimus TARGET-eluting coronary stent: protocol of the TARGET DAPT trial. BMJ Open. 2019 Dec 17;9(12):e033774. doi: 10.1136/bmjopen-2019-033774.