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

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

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.

Study Overview

• Status: Unknown
• Conditions: Percutaneous Coronary Intervention; Drug-Eluting Stents
• Intervention / Treatment: Drug: 3 months DAPT; Drug: 12 months DAPT

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 Type: Interventional
• Enrollment (Anticipated): 2446
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ming Zheng, MD; Phone Number: (86)(10)66513642-6229; Email: mzheng@microport.com

Study Locations

• China
  • Shanghai, China, 200032
    • Recruiting
    • Shanghai Zhongshan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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..

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 3 months DAPT Intervention; 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.	Drug: 3 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.; Other Names: Ticagrelor (180 mg/day) or Clopidogrel (75 mg/day)
ACTIVE_COMPARATOR: 12 months DAPT Intervention; 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.	Drug: 12 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.; Other Names: Ticagrelor (180 mg/day) or Clopidogrel (75 mg/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 18 months after index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 18 months after index procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	the definite and probable stent thrombosis	In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure.
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.
Target Lesion Failure (TLF)		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.
Major bleeding (ARC definition and GUSTO definition)		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.
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

Collaborators and Investigators

• Sponsor: Shanghai MicroPort Medical (Group) Co., Ltd.
• Investigators: Principal Investigator: Junbo Ge, MD, Affiliated Zhongshan Hospital of Fudan University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 10, 2019
• Primary Completion (ANTICIPATED): December 1, 2020
• Study Completion (ANTICIPATED): October 1, 2022

Study Registration Dates

• First Submitted: December 6, 2016
• First Submitted That Met QC Criteria: December 30, 2016
• First Posted (ESTIMATE): January 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 8, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Ticagrelor; Clopidogrel
• Other Study ID Numbers: TARGET DAPT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices) will be shared. Additionally, study protocol will be available. The data will become available for the beginning 3 months and ending 5 years following article publication. The access criteria are as follow:

• (With) Researchers who provide a methodologically sound proposal.
• (For the analysis) to achieve aims in the approved proposal.
• (Requisite mechanism) Proposals should be directed to mzheng@microport.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link to be included).

If the data sharing plan changes after registration, this should be reflected in the statement submitted and published with the manuscript, and updated in the registry record.

• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication
• IPD Sharing Access Criteria: (With) Researchers who provide a methodologically sound proposal.; (For the analysis) to achieve aims in the approved proposal.; (Requisite mechanism) Proposals should be directed to mzheng@microport.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link to be included).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No