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

NCT03008083 | Unknown Phase 4

• 1 other identifier: TARGET DAPT
• Study Type: interventional
• Target: 2,446
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug-Eluting Stents; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cost-Effectiveness Ratio (CER)

  At 18 months after index procedure

Other Outcomes (14)

• 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)

  In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure.

Study Arms (2)

3 months DAPT Intervention

ACTIVE COMPARATOR

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

12 months DAPT Intervention

ACTIVE COMPARATOR

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

Interventions

3 months DAPT DRUG

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.

Also known as: Ticagrelor (180 mg/day) or Clopidogrel (75 mg/day)

3 months DAPT Intervention

12 months DAPT DRUG

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.

Also known as: Ticagrelor (180 mg/day) or Clopidogrel (75 mg/day)

12 months DAPT Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Shanghai MicroPort Medical (Group) Co., Ltd.: lead

Study Sites (1)

Shanghai Zhongshan Hospital

Shanghai, 200032, China

RECRUITING

Related Publications (2)

• Yang H, Zhang F, Zhang X, Wu Y, Zhong Z, Wang J, Zhou Y, Hong L, Yang W, Jiang T, Zou J, Zhang Z, Ma Y, Wen S, Fan Z, Xu D, Jiang H, Tao J, Ren H, Xia Y, Huang Y, Xu G, Cao R, Zheng M, Qian J, Francese DP, Lansky AJ, Ge J; TARGET DAPT Investigators. Three vs 12-month DAPT after implantation of biodegradable-polymer sirolimus-eluting coronary stent: a randomised clinical trial. BMC Med. 2025 Dec 24;23(1):690. doi: 10.1186/s12916-025-04515-y.

  PMID: 41444578 DERIVED

• 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.

  PMID: 31852711 DERIVED

MeSH Terms

Interventions

2'-deoxythymidylyl-(3'-5')-2'-deoxyadenosine; Ticagrelor; Clopidogrel

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Junbo Ge, MD

  Affiliated Zhongshan Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Zheng, MD

CONTACT

(86)(10)66513642-6229; mzheng@microport.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: January 2, 2017
• Study Start: January 10, 2019
• Primary Completion: December 1, 2020
• Study Completion: October 1, 2022
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 3 months and ending 5 years following article publication
• 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).

Locations

CN (1)