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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05548023
• Other study ID #: 2023.464
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 8, 2023
• Est. completion date: February 7, 2025

Study information

• Verified date: February 2024
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: February 7, 2025
• Est. primary completion date: December 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	MACE reduction by TQJ230	Demonstrate the superiority of TQJ230 compared to placebo in reducing the risk of the MACE composite of CV death, non-fatal MI and non-fatal stroke.	51 months
Secondary	coronary heart disease (CHD) outcomes by TQJ230	Demonstrate the superiority of TQJ230 compared to placebo in reducing the risk of the composite of coronary heart disease (CHD) outcomes: death due to CHD, non-fatal MI and urgent coronary re-vascularization requiring hospitalization. Evaluate the rate of all cause death.	51 months