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

Sino Medical Sciences Technology Inc.

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Coronary Artery Disease

Interventions

HT SupremeDEVICE

HT Supreme ( R\&D by Sinomed, Tianjin, China)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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)

Time frame: 12 months post-procedure

Secondary Outcomes

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)

Time frame: 2 and 3 years post-procedure

Rate of Individual components of patient-oriented composite endpoint;

Time frame: 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)

Time frame: 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)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.