Comparison Three vs Twelve Months of Dual Anti-Platelet Therapy After Stent Implantation

Phase 4

• Conditions: Percutaneous Coronary Intervention; Drug-Eluting Stents
• Interventions: Drug: 3 months DAPT; Drug: 12 months DAPT

• Registration Number: NCT03008083
• Lead Sponsor: Shanghai MicroPort Medical (Group) Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2016-12-06
• Study First Submitted QC: 2016-12-30
• Study First Posted: 2017-01-02
• Study Start: 2019-01-10
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-08
• Last Update Posted: 2020-09-09
• Primary Completion: 2020-12
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2446

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..

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3 months DAPT Intervention	3 months DAPT	After implantation of Firehawk coronary stents, all subjects in intervention group will be given dual anti-platelet therapy (DAPT) including aspirin and thienopyridines (clopidogrel or ticagrelor)for 3 months.
12 months DAPT Intervention	12 months DAPT	After implantation of Firehawk coronary stents, all subjects in control group will be given dual anti-platelet therapy (DAPT) including aspirin and thienopyridines (clopidogrel or ticagrelor)for 12 months.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Cost-Effectiveness Ratio (CER)	At 18 months after index procedure	CER = \[total medical care costs of anti-platelet therapy\] / \[number of participants without net adverse clinical and cerebral events (NACCE)\]

Trial Locations

Locations (1)

Shanghai Zhongshan Hospital; 🇨🇳 Shanghai, China