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Drug-Eluting StentsPhase 4NCT03008083

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

A Phase 4 study testing 3 months DAPT and 12 months DAPT in people with Drug-Eluting Stents and Percutaneous Coronary Intervention, run by Shanghai MicroPort Medical (Group) Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
3 months DAPT and 12 months DAPT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,446 participants
Where
1 siteChina
Study dates
10 Jan 2019to Oct 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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..

Trial locations and contacts

1 site in 1 country.

Ming Zheng, MD contact

(86)(10)66513642-6229

mzheng@microport.com

China1 site, 1 recruiting

  • Shanghai Zhongshan Hospital

    Shanghai, 200032

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Being tested
3 months DAPT, 12 months DAPT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3 months DAPTDrug

    Also called Ticagrelor (180 mg/day) or Clopidogrel (75 mg/day)

    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.

  • 12 months DAPTDrug

    Also called Ticagrelor (180 mg/day) or Clopidogrel (75 mg/day)

    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.

Study groups in NCT03008083
Study groupRoleWhat they receive
3 months DAPT InterventionActive comparatorAfter 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.
Receives: Drug: 3 months DAPT
12 months DAPT InterventionActive comparatorAfter 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.
Receives: Drug: 12 months DAPT

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: At 18 months after index procedure

Secondary outcomes (1)

  1. Cost-Effectiveness Ratio (CER)

    CER = [total medical care costs of anti-platelet therapy] / [number of participants without net adverse clinical and cerebral events (NACCE)]

    Measured: At 18 months after index procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2017 (estimated)
  2. Study start10 Jan 2019
  3. Primary completionDec 2020 (estimated)
  4. Study completionOct 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,446 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03008083
Sponsor's protocol ID
TARGET DAPT
Status last verified
Sep 2020
First submitted
6 Dec 2016
Last updated
9 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 41444578

  • 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.

    PubMed 31852711

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 3 months DAPT and 12 months DAPT in people with Drug-Eluting Stents and Percutaneous Coronary Intervention, run by Shanghai MicroPort Medical (Group) Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ming Zheng, MD ((86)(10)66513642-6229, mzheng@microport.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Net Adverse Clinical and Cerebral Events (NACCE) (time frame: At 18 months after index procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03008083, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.

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