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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: HT Supreme

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HT Supreme; 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	Device: HT Supreme; HT Supreme ( R&D by Sinomed, Tianjin, China)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	12 months post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	2 and 3 years post-procedure
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)	1, 2 and 3 years post-procedure
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)	1, 2 and 3 years post-procedure
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)	1, 2 and 3 years post-procedure
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	30days, 6months, annually up to 3 years post procedure
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	30days, 6months, annually up to 3 years post procedure
Rate of Pre-procedural myocardioal infarction according to 4th universal definition;	Fourth Universal Definition of Myocardial Infarction (2018)	30days, 6months, annually up to 3 years post procedure
Device Success Rate	according to the statement from European Association of Percutaneous Cardiovascular Interventions (EAPCI) of the European Society of Cardiology (ESC))	intra-operative
Rate of Stent thrombosis	Stent thrombosis is consist of Definite stent thrombosis; Probable stent thrombosis; Definite or probable stent thrombosis	30days, 6months, annually up to 3 years post procedure
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	30days, 6months, annually up to 3 years post procedure
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	30days, 6months, annually up to 3 years post procedure
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	30days, 6months, annually up to 3 years post procedure
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)	30days, 6months, annually up to 3 years post procedure
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).	hospitalization, 1 year post procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of the struts' neointimal coverage (%) measured by OCT	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	1 month post procedure
Neointimal hyperplasia area/volume measured by OCT	80 patients enrolled with an extra one-month OCT follow-up as a subgroup analysis target. OCT measures Neointimal hyperplasia area(mm2)/volume(mm3)	1 month post procedure
Mean/Minimal Stent diameter/area/volume	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)	1 month post procedure
Mean/maximal thickness of the struts coverage(%)	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	1 month post procedure
Mean/Minimal Lumen diameter/area/volume	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)	1 month post procedure
Incomplete strut apposition（%）	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	1 month post procedure

Collaborators and Investigators

• Sponsor: Sino Medical Sciences Technology Inc.
• Collaborators: The Second Affiliated Hospital of Harbin Medical University
• Investigators: Principal Investigator: Bo Yu, PH.D, The Second Affiliated Hospital of Harbin Medical University; Study Director: Haibo Jia, PH.D, The Second Affiliated Hospital of Harbin Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2021
• Primary Completion (Estimated): September 1, 2022
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: August 1, 2021
• First Submitted That Met QC Criteria: August 16, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Healing-Targeted Supreme; one month DAPT
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: PIONEER IV CHINA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No