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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| 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. |
General Inclusion Criteria:
Angiographic Inclusion Criteria:
Clinical Exclusion Criteria:
Angiographic Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming Zheng, MD | Contact | (86)(10)66513642-6229 | mzheng@microport.com |
| Name | Affiliation | Role |
|---|---|---|
| Junbo Ge, MD | Affiliated Zhongshan Hospital of Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Zhongshan Hospital | Recruiting | Shanghai | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41444578 | Derived | 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. | |
| 31852711 |
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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:
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.
Beginning 3 months and ending 5 years following article publication
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 16, 2025 | |
| Reset | Dec 4, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 16, 2025 | Dec 4, 2025 |
| ID | Term |
|---|---|
| C028145 | 2'-deoxythymidylyl-(3'-5')-2'-deoxyadenosine |
| D000077486 | Ticagrelor |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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|
| 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. |
|
|
| 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 |
| 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. |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |