Time-trend Analysis of Clinical Characteristic and Outcomes in Patients With Unprotected Left Main Coronary Artery Disease Treated With PCI Over a 10-year Period

NCT05548023 | Active Not Recruiting

• 1 other identifier: 2023.464
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Surgical coronary bypass surgery (CABG) has been demonstrated to confer significant survival benefit over medical therapies patients with LMCA in earlier clinical trials1,2,3 and therefore was the revascularization modality of choice for a long time. Recently, several randomized controlled trials and meta-analyses have shown percutaneous coronary intervention (PCI) to be non-inferior to CABG in the treatment of LMCA disease4,5,6,7,8. PCI is now considered to be an appropriate alternative to CABG for LMCA disease in patients with suitable anatomy9,10. Over recent decades, LMCA PCI has been performed in patients with increasing anatomical complexity and higher risk profiles (e.g. elderly, heart failure, renal failure etc). 11,12. In recent years, remarkable advancement in interventional techniques and technologies such as 2nd/3rd generation DES and potent antiplatelet therapy have contributed to the improvement of PCI success rates and reduction in complications and adverse events. Knowledge related to long term temporal variation of clinical and procedural characteristics and outcomes in patients with LMCA disease treated with PCI will therefore be important to inform and define future treatment strategies. This proposal aims to evaluate time-trends and regional differences in clinical characteristics and outcomes of patients with LMCA disease treated with PCI in the Asia-Pacific region

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Risk reduction of expanded MACE by TQJ230

  To demonstrate the superiority of TQJ230 compared to placebo in reducing the risk of expanded MACE (cardiovascular death, non-fatal MI, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in 1) the overall study population with established CVD (Lp(a) ≥ 70 mg/dL) and/or 2) in a subpopulation with established CVD and Lp(a) ≥ 90 mg/dL.

  51 months

Secondary Outcomes (2)

• MACE reduction by TQJ230

  51 months

• coronary heart disease (CHD) outcomes by TQJ230

  51 months

Study Arms (1)

unprotected left main coronary artery disease treated with PCI

OTHER

Device: The AngioliteTM Durable Fluoroacrylate Polymer-based Sirolimus-Eluting Stent

Interventions

The AngioliteTM Durable Fluoroacrylate Polymer-based Sirolimus-Eluting Stent DEVICE

The Angiolite stent is a thin-strut cobalt-chromium sirolimus-eluting stent with an open-cell design and a high overexpansion capacity that might overcomes some of these challenges in LMCA PCI. The ANGIOLITE randomized trial confirmed the non-inferiority of the Angiolite stent against the conventional DES

unprotected left main coronary artery disease treated with PCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Lp(a) ≥ 70 mg/dL at the screening visit
• Optimal LDL-cholesterol lowering treatment
• Optimal treatment of other CV risk factors
• Myocardial infarction: ≥ 3 months to ≤ 10 years prior to the screening visit, and/or
• Ischemic stroke: ≥ 3 months to ≤ 10 years prior to the screening visit, and/or
• Clinically significant symptomatic peripheral artery disease

You may not qualify if:

• Uncontrolled hypertension
• Heart failure New York Heart Association (NYHA) class IV
• History of malignancy of any organ system
• History of hemorrhagic stroke or other major bleeding
• Platelet count \<140,000 per μL
• Active liver disease or hepatic dysfunction

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Shatin, 999077, Hong Kong

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Bryan Yan

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: September 21, 2022
• Study Start: December 8, 2023
• Primary Completion: December 8, 2024
• Study Completion: February 7, 2025
• Last Updated: February 16, 2024

Record last verified: 2024-02

Locations

HK (1)