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A Study to Evaluate the Impact of 11-month Ticagrelor Monotherapy Following One-month DAPT After PCI

Primary Purpose

Coronary Artery Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HT Supreme
Sponsored by
Sino Medical Sciences Technology Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Healing-Targeted Supreme, one month DAPT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female patient ≥18 years of age;
  2. Patient has chronic stable angina, acute coronary syndromes or silent ischemia;
  3. Presence of one or more coronary artery stenoses of ≥50% (by visual assessment) in a native coronary artery (with or without prior stent/other device treatment) or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation;
  4. The vessel should have a reference vessel diameter of at least 2.25 mm by visual assessment (no limitation on the number of treated lesions, vessels, or lesion length);
  5. Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee and is willing to comply with all protocol-required (follow-up) evaluations.

Exclusion Criteria:

  1. under 18 years of age;
  2. Unable to sign written informed consent
  3. Patient is a woman who is pregnant or nursing
  4. Known intolerance to cobalt chromium, and medications such as sirolimus, aspirin, heparin, bivalirudin or P2Y12 inhibitors;
  5. Planned major elective surgery requiring discontinuation of DAPT within 12 months of procedure;
  6. Concurrent medical condition with a life expectancy of less than 3 years;
  7. Currently participating in another trial and not yet at its primary endpoint
  8. Active pathological bleeding;
  9. History of intracranial haemorrhage.

OCT exclusion criteria

  1. Left main lesion
  2. Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in suboptimal imaging or excessive risk of complication from placement of an OCT catheter
  3. Total occlusion or thrombolysis in myocardial infarction(TIMI) flow 0, prior to wire crossing.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    HT Supreme

    Arm Description

    Device: HT Supreme ( R&D by Sinomed, Tianjin, China) Drug: 11-month ticagrelor monotherapy following one-month dual antiplatelet therapy (DAPT) after HT Supreme drug-eluting stent system interventions

    Outcomes

    Primary Outcome Measures

    Rate of Patient-oriented Composite Endpoint (PoCE) at 12 months post-procedure.
    PoCE is a composite clinical endpoint of: all-cause death; any stroke, Modified Rankin scale, (MRS ≥1); any myocardial infarction (peri-procedural MI according to SCAI, spontaneous according to 4th universal definition); any clinically and physiologically driven revascularization (ARC-2)

    Secondary Outcome Measures

    Rate of Patient oriented composite endpoint (PoCE) at 2 and 3 years;
    PoCE is a composite clinical endpoint of: all-cause death; any stroke, Modified Rankin scale, (MRS ≥1); any myocardial infarction (periprocedural MI according to SCAI, spontaneous according to 4th universal definition); any clinically and physiologically driven revascularization (ARC-2)
    Rate of Individual components of patient-oriented composite endpoint;
    PoCE is a composite clinical endpoint of: all-cause death; any stroke, Modified Rankin scale, (MRS ≥1); any myocardial infarction (periprocedural MI according to SCAI, spontaneous according to 4th universal definition); any clinically and physiologically driven revascularization (ARC-2)
    Rate of Vessel-oriented composite endpoints (VoCE)
    VoCE is a composite clinical endpoint of: Vessel-related cardiovascular Death; Target-vessel related MI; Clinically and physiologically-oriented Target vessel revascularization (ARC-2)
    Rate of Individual components of vessel-oriented composite endpoint;
    VoCE is a composite clinical endpoint of: Vessel-related cardiovascular Death; Target-vessel related MI; Clinically and physiologically-oriented Target vessel revascularization (ARC-2)
    Rate of Device-oriented composite endpoint (DoCE) at all timepoints;
    VoCE is a composite clinical endpoint of: Cardiovascular Death;Target-vessel related MI;Clinically and physiologically-oriented Target lesion revascularization
    Rate of Individual components of device-oriented composite endpoint;
    VoCE is a composite clinical endpoint of: Cardiovascular Death;Target-vessel related MI;Clinically and physiologically-oriented Target lesion revascularization
    Rate of Pre-procedural myocardioal infarction according to 4th universal definition;
    Fourth Universal Definition of Myocardial Infarction (2018)
    Device Success Rate
    according to the statement from European Association of Percutaneous Cardiovascular Interventions (EAPCI) of the European Society of Cardiology (ESC))
    Rate of Stent thrombosis
    Stent thrombosis is consist of Definite stent thrombosis; Probable stent thrombosis; Definite or probable stent thrombosis
    Rate of Target-vessel failure composite endpoint
    TVF is a composite clinical endpoint of: Cardiac death; Myocardial Infarction (MI) (unless clearly attributable to a non target vessel); Target vessel revascularization
    Rate of Individual components of Target-vessel failure composite endpoint
    TVF is a composite clinical endpoint of: Cardiac death; Myocardial Infarction (MI) (unless clearly attributable to a non target vessel); Target vessel revascularization
    Rate of Bleeding according to BARC (2, 3 and 5) classification
    Defining high bleeding risk in patients undergoing percutaneous coronary intervention: a consensus document from the Academic Research Consortium for High Bleeding Risk
    Rate of Net adverse clinical and cerebral events
    NACCE is a composite clinical endpoint of: any cause, myocardial infarction (MI), cerebral vascular accident, and major bleeding (according to the modified REPLACE-2 and GUSTO criteria)
    Cost-Effectiveness
    Cost of procedure will be collected in the eCRF(e.g. diagnostic tests, procedural materials, time of the procedure, re-angiography, repeat revascularization, etc. will be quantified).

    Full Information

    First Posted
    August 1, 2021
    Last Updated
    August 16, 2021
    Sponsor
    Sino Medical Sciences Technology Inc.
    Collaborators
    The Second Affiliated Hospital of Harbin Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05015699
    Brief Title
    A Study to Evaluate the Impact of 11-month Ticagrelor Monotherapy Following One-month DAPT After PCI
    Official Title
    A Prospective, Multi-center, Single-group Target Value Post-marketing Clinical Study to Evaluate the Safety and Effectiveness of the HT Supreme Drug-eluting Stent System in the Treatment of "Real-world" Patients With Coronary Heart Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2021 (Anticipated)
    Primary Completion Date
    September 2022 (Anticipated)
    Study Completion Date
    July 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sino Medical Sciences Technology Inc.
    Collaborators
    The Second Affiliated Hospital of Harbin Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    PIONEER IV CHINA is sought to investigate the safety and efficacy of 11-month ticagrelor monotherapy following one-month dual antiplatelet therapy (DAPT) after HT Supreme drug-eluting stent system at 12 months follow-up.
    Detailed Description
    This study is a prospective, multi-center, single-arm objective performance criteria clinical trial in an all-comers patient population (including patients with high bleeding risk, HBR) undergoing PCI with unrestrictive use of the HT Supreme sirolimus-eluting stent and treated with 11-month ticagrelor monotherapy following one-month dual antiplatelet therapy (DAPT) in approximately 285 patients (including 80 coronary heart disease cases entering the OCT subgroup). All patients will be (at minimum) contacted via visit at 30 days (±7 days) and at 12 months (±30 days), and by phone contact at 6 months (±14 days), 24 months (±30 days) and 36 months (±45 days) post index procedure to assess clinical status and adverse events. The Primary Endpoint for this trial is Patient-oriented Composite Endpoint (PoCE) at 12 months post-procedure.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Artery Disease
    Keywords
    Healing-Targeted Supreme, one month DAPT

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    285 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    HT Supreme
    Arm Type
    Experimental
    Arm Description
    Device: HT Supreme ( R&D by Sinomed, Tianjin, China) Drug: 11-month ticagrelor monotherapy following one-month dual antiplatelet therapy (DAPT) after HT Supreme drug-eluting stent system interventions
    Intervention Type
    Device
    Intervention Name(s)
    HT Supreme
    Intervention Description
    HT Supreme ( R&D by Sinomed, Tianjin, China)
    Primary Outcome Measure Information:
    Title
    Rate of Patient-oriented Composite Endpoint (PoCE) at 12 months post-procedure.
    Description
    PoCE is a composite clinical endpoint of: all-cause death; any stroke, Modified Rankin scale, (MRS ≥1); any myocardial infarction (peri-procedural MI according to SCAI, spontaneous according to 4th universal definition); any clinically and physiologically driven revascularization (ARC-2)
    Time Frame
    12 months post-procedure
    Secondary Outcome Measure Information:
    Title
    Rate of Patient oriented composite endpoint (PoCE) at 2 and 3 years;
    Description
    PoCE is a composite clinical endpoint of: all-cause death; any stroke, Modified Rankin scale, (MRS ≥1); any myocardial infarction (periprocedural MI according to SCAI, spontaneous according to 4th universal definition); any clinically and physiologically driven revascularization (ARC-2)
    Time Frame
    2 and 3 years post-procedure
    Title
    Rate of Individual components of patient-oriented composite endpoint;
    Description
    PoCE is a composite clinical endpoint of: all-cause death; any stroke, Modified Rankin scale, (MRS ≥1); any myocardial infarction (periprocedural MI according to SCAI, spontaneous according to 4th universal definition); any clinically and physiologically driven revascularization (ARC-2)
    Time Frame
    1, 2 and 3 years post-procedure
    Title
    Rate of Vessel-oriented composite endpoints (VoCE)
    Description
    VoCE is a composite clinical endpoint of: Vessel-related cardiovascular Death; Target-vessel related MI; Clinically and physiologically-oriented Target vessel revascularization (ARC-2)
    Time Frame
    1, 2 and 3 years post-procedure
    Title
    Rate of Individual components of vessel-oriented composite endpoint;
    Description
    VoCE is a composite clinical endpoint of: Vessel-related cardiovascular Death; Target-vessel related MI; Clinically and physiologically-oriented Target vessel revascularization (ARC-2)
    Time Frame
    1, 2 and 3 years post-procedure
    Title
    Rate of Device-oriented composite endpoint (DoCE) at all timepoints;
    Description
    VoCE is a composite clinical endpoint of: Cardiovascular Death;Target-vessel related MI;Clinically and physiologically-oriented Target lesion revascularization
    Time Frame
    30days, 6months, annually up to 3 years post procedure
    Title
    Rate of Individual components of device-oriented composite endpoint;
    Description
    VoCE is a composite clinical endpoint of: Cardiovascular Death;Target-vessel related MI;Clinically and physiologically-oriented Target lesion revascularization
    Time Frame
    30days, 6months, annually up to 3 years post procedure
    Title
    Rate of Pre-procedural myocardioal infarction according to 4th universal definition;
    Description
    Fourth Universal Definition of Myocardial Infarction (2018)
    Time Frame
    30days, 6months, annually up to 3 years post procedure
    Title
    Device Success Rate
    Description
    according to the statement from European Association of Percutaneous Cardiovascular Interventions (EAPCI) of the European Society of Cardiology (ESC))
    Time Frame
    intra-operative
    Title
    Rate of Stent thrombosis
    Description
    Stent thrombosis is consist of Definite stent thrombosis; Probable stent thrombosis; Definite or probable stent thrombosis
    Time Frame
    30days, 6months, annually up to 3 years post procedure
    Title
    Rate of Target-vessel failure composite endpoint
    Description
    TVF is a composite clinical endpoint of: Cardiac death; Myocardial Infarction (MI) (unless clearly attributable to a non target vessel); Target vessel revascularization
    Time Frame
    30days, 6months, annually up to 3 years post procedure
    Title
    Rate of Individual components of Target-vessel failure composite endpoint
    Description
    TVF is a composite clinical endpoint of: Cardiac death; Myocardial Infarction (MI) (unless clearly attributable to a non target vessel); Target vessel revascularization
    Time Frame
    30days, 6months, annually up to 3 years post procedure
    Title
    Rate of Bleeding according to BARC (2, 3 and 5) classification
    Description
    Defining high bleeding risk in patients undergoing percutaneous coronary intervention: a consensus document from the Academic Research Consortium for High Bleeding Risk
    Time Frame
    30days, 6months, annually up to 3 years post procedure
    Title
    Rate of Net adverse clinical and cerebral events
    Description
    NACCE is a composite clinical endpoint of: any cause, myocardial infarction (MI), cerebral vascular accident, and major bleeding (according to the modified REPLACE-2 and GUSTO criteria)
    Time Frame
    30days, 6months, annually up to 3 years post procedure
    Title
    Cost-Effectiveness
    Description
    Cost of procedure will be collected in the eCRF(e.g. diagnostic tests, procedural materials, time of the procedure, re-angiography, repeat revascularization, etc. will be quantified).
    Time Frame
    hospitalization, 1 year post procedure
    Other Pre-specified Outcome Measures:
    Title
    The percentage of the struts' neointimal coverage (%) measured by OCT
    Description
    80 patients enrolled with an extra one-month OCT follow-up as a subgroup analysis target. OCT examination was carried out at 1 month after the operation to evaluate percentage of the struts' neointimal coverage
    Time Frame
    1 month post procedure
    Title
    Neointimal hyperplasia area/volume measured by OCT
    Description
    80 patients enrolled with an extra one-month OCT follow-up as a subgroup analysis target. OCT measures Neointimal hyperplasia area(mm2)/volume(mm3)
    Time Frame
    1 month post procedure
    Title
    Mean/Minimal Stent diameter/area/volume
    Description
    80 patients enrolled with an extra one-month OCT follow-up as a subgroup analysis target. OCT measures Mean/Minimal Stent diameter(mm)/area(mm2)/volume(mm3)
    Time Frame
    1 month post procedure
    Title
    Mean/maximal thickness of the struts coverage(%)
    Description
    80 patients enrolled with an extra one-month OCT follow-up as a subgroup analysis target. OCT measures Mean/maximal thickness of the struts coverage
    Time Frame
    1 month post procedure
    Title
    Mean/Minimal Lumen diameter/area/volume
    Description
    80 patients enrolled with an extra one-month OCT follow-up as a subgroup analysis target. OCT measures Mean/Minimal Lumen diameter(mm)/area(mm2)/volume(mm3)
    Time Frame
    1 month post procedure
    Title
    Incomplete strut apposition(%)
    Description
    80 patients enrolled with an extra one-month OCT follow-up as a subgroup analysis target. OCT examination was carried out at 1 month after the operation to evaluate incomplete strut apposition
    Time Frame
    1 month post procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female patient ≥18 years of age; Patient has chronic stable angina, acute coronary syndromes or silent ischemia; Presence of one or more coronary artery stenoses of ≥50% (by visual assessment) in a native coronary artery (with or without prior stent/other device treatment) or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation; The vessel should have a reference vessel diameter of at least 2.25 mm by visual assessment (no limitation on the number of treated lesions, vessels, or lesion length); Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee and is willing to comply with all protocol-required (follow-up) evaluations. Exclusion Criteria: under 18 years of age; Unable to sign written informed consent Patient is a woman who is pregnant or nursing Known intolerance to cobalt chromium, and medications such as sirolimus, aspirin, heparin, bivalirudin or P2Y12 inhibitors; Planned major elective surgery requiring discontinuation of DAPT within 12 months of procedure; Concurrent medical condition with a life expectancy of less than 3 years; Currently participating in another trial and not yet at its primary endpoint Active pathological bleeding; History of intracranial haemorrhage. OCT exclusion criteria Left main lesion Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in suboptimal imaging or excessive risk of complication from placement of an OCT catheter Total occlusion or thrombolysis in myocardial infarction(TIMI) flow 0, prior to wire crossing.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ligang Xia
    Phone
    18612448465
    Email
    xialigang@sinomed.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bo Yu, PH.D
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bo Yu, PH.D
    Organizational Affiliation
    The Second Affiliated Hospital of Harbin Medical University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Haibo Jia, PH.D
    Organizational Affiliation
    The Second Affiliated Hospital of Harbin Medical University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Study to Evaluate the Impact of 11-month Ticagrelor Monotherapy Following One-month DAPT After PCI

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