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
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Healing-Targeted Supreme, one month DAPT
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.
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
NCT ID
NCT05015699
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
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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