<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03008083</url>
  </required_header>
  <id_info>
    <org_study_id>TARGET DAPT</org_study_id>
    <nct_id>NCT03008083</nct_id>
  </id_info>
  <brief_title>Comparison Three vs Twelve Months of Dual Anti-Platelet Therapy After Stent Implantation</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai MicroPort Medical (Group) Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai MicroPort Medical (Group) Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a prospective,multi-center, open-label, randomized controlled clinical&#xD;
      trial,aims to assess the clinical noninferiority of 3 months (short-term) vs 12 months&#xD;
      (long-term) of Dual Anti-Platelet Therapy (DAPT) in patients undergoing percutaneous coronary&#xD;
      intervention implanted sirolimus target- eluting stent with abluminal grooves containing a&#xD;
      biodegradable polymer (Firehawk™ stent). All participants met the inclusion criteria begin&#xD;
      taking aspirin and open-label thienopyridine therapy before index procedure, and will be 1:1&#xD;
      randomized to 3 months or 12 month of DAPT at index procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will recruit 2,446 subjects with stable coronary artery disease in no more than 40&#xD;
      research centers in China. All participants met the inclusion criteria will be 1:1 randomized&#xD;
      to 3 months or 12 month of DAPT after implanting Firehawk™ coronary stent.Clinical follow-up&#xD;
      will be carried out at 30 days, 3 months, 6 months, 12 months, 18 months, 2 years and 3 years&#xD;
      after index procedure.The primary study endpoint is Net Adverse Clinical and Cerebral Events&#xD;
      (NACCE), a composite of all-cause death, myocardial infarction (MI), cerebral vascular&#xD;
      accident (CVA) and major bleeding (academic research consortium [ARC] definition and GUSTO&#xD;
      definition) at 18 months. Subjects that complete of 18 months follow-up will be regarded as&#xD;
      having completed the primary endpoint. The secondary study endpoints contain ARC defined&#xD;
      stent thrombosis (ST) at all study time-points; NACCE at 30 days,6,12,24 and 36 months of&#xD;
      follow-up;major adverse cardiovascular events (MACE),major adverse cardiovascular and&#xD;
      cerebral events (MACCE),target lesion revascularization (TLR),target lesion failure(TLF),ST&#xD;
      at 30 days,6,12 ,18,24 and 36 months of follow-up; major bleeding at 1, 3, 6, 12 ,18,24 and&#xD;
      36 months of follow up; as well as cost-effective at 18 months of follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 10, 2019</start_date>
  <completion_date type="Anticipated">October 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Net Adverse Clinical and Cerebral Events (NACCE)</measure>
    <time_frame>At 18 months after index procedure</time_frame>
    <description>A composite of all-cause death, MI, cerebral vascular accident (CVA) and major bleeding at 18 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cost-Effectiveness Ratio (CER)</measure>
    <time_frame>At 18 months after index procedure</time_frame>
    <description>CER = [total medical care costs of anti-platelet therapy] / [number of participants without net adverse clinical and cerebral events (NACCE)]</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Net Adverse Clinical and Cerebral Events (NACCE)</measure>
    <time_frame>In hospital and at 30 days, 3, 6, 12, 24 and 36 months after index procedure.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Major Adverse Cardiac and Cerebral Events (MACCE)</measure>
    <time_frame>In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Stent Thrombosis (per ARC definition)</measure>
    <time_frame>In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure.</time_frame>
    <description>the definite and probable stent thrombosis</description>
  </other_outcome>
  <other_outcome>
    <measure>Target Vessel Revascularization (TVR)</measure>
    <time_frame>In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Target Lesion Revascularization (TLR)</measure>
    <time_frame>In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Target Vessel Failure (TVF)</measure>
    <time_frame>In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Target Lesion Failure (TLF)</measure>
    <time_frame>In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Myocardial Infarction (MI,including Q-wave MI and non Q-wave MI)</measure>
    <time_frame>In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Major bleeding (ARC definition and GUSTO definition)</measure>
    <time_frame>In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Death (All cause, Cardiac, Non-cardiac)</measure>
    <time_frame>In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Cardiac Death/ All Myocardial Infarction</measure>
    <time_frame>In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Procedural Success</measure>
    <time_frame>At time of procedure up to 7 days in hospital</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Minimal Lumen Diameter (MLD)（In-device, in-segment, proximal 5 mm and distal 5 mm)</measure>
    <time_frame>Instantly after index procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>The Immediate Lumen Gain</measure>
    <time_frame>Instantly after index procedure</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">2446</enrollment>
  <condition>Drug-Eluting Stents</condition>
  <condition>Percutaneous Coronary Intervention</condition>
  <arm_group>
    <arm_group_label>3 months DAPT Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>12 months DAPT Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>3 months DAPT</intervention_name>
    <description>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.</description>
    <arm_group_label>3 months DAPT Intervention</arm_group_label>
    <other_name>Ticagrelor (180 mg/day) or Clopidogrel (75 mg/day)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>12 months DAPT</intervention_name>
    <description>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.</description>
    <arm_group_label>12 months DAPT Intervention</arm_group_label>
    <other_name>Ticagrelor (180 mg/day) or Clopidogrel (75 mg/day)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        General Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years;&#xD;
&#xD;
          -  Subjects (or legal guardians) understand the testing requirements and procedures, and&#xD;
             provide written informed consent;&#xD;
&#xD;
          -  Subjects with symptomatic coronary artery disease or confirmed asymptomatic ischemia;&#xD;
&#xD;
          -  Target lesion should be new lesion with visually estimated reference diameter ≥2.5 mm&#xD;
             and ≤4.0 mm in autologous coronary artery;&#xD;
&#xD;
          -  Subjects willing to accept PCI therapy and to implant Firehawk™ stent only;&#xD;
&#xD;
          -  Left ventricular ejection fraction (LVEF) ≥ 30%;&#xD;
&#xD;
          -  Subjects willing to accept the trial plan calls for all subsequent evaluations.&#xD;
&#xD;
        Angiographic Inclusion Criteria:&#xD;
&#xD;
          -  Target lesions must be new and have a visually estimated reference diameter ≥2.5 mm&#xD;
             and ≤4.0 mm in autologous coronary artery;&#xD;
&#xD;
          -  No limitations in target lesion length and number;&#xD;
&#xD;
          -  The first target lesion must be able to successfully expand and implant Firehawk™&#xD;
             stent.&#xD;
&#xD;
        Clinical Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with ST-segment elevation myocardial infarction:&#xD;
&#xD;
          -  Subjects having an organ transplant or waiting for an organ transplant&#xD;
&#xD;
          -  Subjects receiving chemotherapy or going to receive a chemotherapy within 30 days&#xD;
             after PCI&#xD;
&#xD;
          -  Subjects undergoing chronic (over 72 hours) anticoagulant therapy (such as heparin and&#xD;
             coumarin) other than acute coronary syndrome&#xD;
&#xD;
          -  Subjects with abnormal counts of platelet and white blood cell (WBC) (investigator&#xD;
             assess clinical significance combine normal reference range of laboratory)&#xD;
&#xD;
          -  Subjects with confirmed or suspected liver disease, including hepatitis lab results&#xD;
&#xD;
          -  Subjects with elevated serum creatinine level &gt;3.0mg/dL or undergoing dialysis therapy&#xD;
&#xD;
          -  Subjects with active peptic ulcer, active gastrointestinal (GI) bleeding or other&#xD;
             bleeding diathesis or coagulopathy, or refused a blood transfusion&#xD;
&#xD;
          -  Subjects with cerebral vascular accident (CVA) or transient ischemic attack (TIA) in&#xD;
             the past 6 months, or with permanent nerve defects&#xD;
&#xD;
          -  Subjects undergoing any PCI treatment in target vessels within 12 months prior to&#xD;
             baseline&#xD;
&#xD;
          -  Subjects planned to undergo PCI or CABG within 18 months after the baseline PCI&#xD;
&#xD;
          -  Subjects with a history of any coronary endovascular brachytherapy treatment&#xD;
             previously&#xD;
&#xD;
          -  Subjects associated with drugs allergy (such as sirolimus, or structure-related&#xD;
             compounds fluorinated polymers, thienopyridine or aspirin)&#xD;
&#xD;
          -  Subjects being suffered from other serious illness (such as cancer, congestive heart&#xD;
             failure), which may cause drop in life expectancy to less than 18 months&#xD;
&#xD;
          -  Subjects with a history of drug abuse (such as alcohol, cocaine, heroin, etc.)&#xD;
&#xD;
          -  Subject planned to undergo any operations that may lead to confuse with the programme&#xD;
&#xD;
          -  Subjects participating in another study of drug or medical device which did not meet&#xD;
             its primary endpoint&#xD;
&#xD;
          -  Subjects planned to pregnant within 18 months after baseline&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
        Angiographic Exclusion Criteria:&#xD;
&#xD;
          -  Target lesions with the following criteria: left main, saphenous vein grafts or&#xD;
             arterial grafts, via saphenous vein grafts or arterial graft, and in-stent restenosis;&#xD;
&#xD;
          -  Subjects with unprotected left main coronary artery disease (diameter stenosis &gt;50%);&#xD;
&#xD;
          -  Protected left main coronary artery disease(diameter stenosis &gt;50% and undergoing&#xD;
             CABG)with target lesions located in left anterior descending artery and left&#xD;
             circumflex artery;&#xD;
&#xD;
          -  Additional lesions of clinical significance possibly needing interventional within 18&#xD;
             months after enrollment..&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Junbo Ge, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Affiliated Zhongshan Hospital of Fudan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ming Zheng, MD</last_name>
    <phone>(86)(10)66513642-6229</phone>
    <email>mzheng@microport.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shanghai Zhongshan Hospital</name>
      <address>
        <city>Shanghai</city>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>September 8, 2020</last_update_submitted>
  <last_update_submitted_qc>September 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clopidogrel</mesh_term>
    <mesh_term>Ticagrelor</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_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:&#xD;
(With) Researchers who provide a methodologically sound proposal.&#xD;
(For the analysis) to achieve aims in the approved proposal.&#xD;
(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).&#xD;
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_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Beginning 3 months and ending 5 years following article publication</ipd_time_frame>
    <ipd_access_criteria>(With) Researchers who provide a methodologically sound proposal.&#xD;
(For the analysis) to achieve aims in the approved proposal.&#xD;
(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_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03008083
org study id: TARGET DAPT
nct id: NCT03008083
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Net Adverse Clinical and Cerebral Events (NACCE)
time frame: At 18 months after index procedure
description: A composite of all-cause death, MI, cerebral vascular accident (CVA) and major bleeding at 18 months
measure: Cost-Effectiveness Ratio (CER)
time frame: At 18 months after index procedure
description: CER = [total medical care costs of anti-platelet therapy] / [number of participants without net adverse clinical and cerebral events (NACCE)]
measure: Net Adverse Clinical and Cerebral Events (NACCE)
time frame: In hospital and at 30 days, 3, 6, 12, 24 and 36 months after index procedure.
measure: Major Adverse Cardiac and Cerebral Events (MACCE)
time frame: In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure.
measure: Stent Thrombosis (per ARC definition)
time frame: In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure.
description: the definite and probable stent thrombosis
measure: Target Vessel Revascularization (TVR)
time frame: In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure.
measure: Target Lesion Revascularization (TLR)
time frame: In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure.
measure: Target Vessel Failure (TVF)
time frame: In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure.
measure: Target Lesion Failure (TLF)
time frame: In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure.
measure: Myocardial Infarction (MI,including Q-wave MI and non Q-wave MI)
time frame: In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure.
measure: Major bleeding (ARC definition and GUSTO definition)
time frame: In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure.
measure: Death (All cause, Cardiac, Non-cardiac)
time frame: In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure.
measure: Cardiac Death/ All Myocardial Infarction
time frame: In hospital and at 30 days, 3, 6, 12 ,18, 24 and 36 months after index procedure.
measure: Procedural Success
time frame: At time of procedure up to 7 days in hospital
measure: Minimal Lumen Diameter (MLD)（In-device, in-segment, proximal 5 mm and distal 5 mm)
time frame: Instantly after index procedure
measure: The Immediate Lumen Gain
time frame: Instantly after index procedure
arm group label: 3 months DAPT Intervention
arm group type: Active Comparator
description: 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.
arm group label: 12 months DAPT Intervention
arm group type: Active Comparator
description: 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.
intervention type: Drug
intervention name: 3 months DAPT
description: 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.
arm group label: 3 months DAPT Intervention
other name: Ticagrelor (180 mg/day) or Clopidogrel (75 mg/day)
intervention type: Drug
intervention name: 12 months DAPT
description: 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.
arm group label: 12 months DAPT Intervention
other name: Ticagrelor (180 mg/day) or Clopidogrel (75 mg/day)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Junbo Ge, MD
role: Principal Investigator
affiliation: Affiliated Zhongshan Hospital of Fudan University
last name: Ming Zheng, MD
phone: (86)(10)66513642-6229
email: mzheng@microport.com
facility: 
status: Recruiting
country: China
responsible party type: Sponsor
mesh term: Clopidogrel
mesh term: Ticagrelor
sharing ipd: Yes
ipd 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 info type: Study Protocol
ipd time frame: Beginning 3 months and ending 5 years following article publication
ipd 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).