Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| unprotected left main coronary artery disease treated with PCI | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| coronary heart disease (CHD) outcomes by TQJ230 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bryan Yan | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Chinese University of Hong Kong | Shatin | 999077 | Hong Kong |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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 |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided