24 Versus 12-Month Dual Antiplatelet Therapy After Drug-Eluting Stent in Patients With Elevated Lipoprotein(a) Levels — DAPT-Lp(a)  

Coronary Artery Disease Clinical Trial

Official title: 24-Month Versus 12-Month Dual Antiplatelet Therapy After Drug-Eluting Stent in Patients With Elevated Lipoprotein(a) Levels

Status Not yet recruiting

Clinical Trial Summary

The purpose of this study is (1) to determine whether 24-month dual antiplatelet therapy (DAPT) is superior to 12-month DAPT after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) with respect to major adverse cardiovascular and cerebrovascular events (all-cause death, myocardial infarction, or stroke) in patients with elevated lipoprotein(a)[Lp(a)] levels (>30mg/dL); (2) to determine whether 24-month DAPT is non-inferior to 12-month DAPT after PCI with DES with respect to net adverse clinical events (all-cause death, myocardial infarction, stroke or Bleeding Academic Research Consortium [BARC] type 3 or 5 bleeding) in patients with elevated Lp(a) levels (>30mg/dL).

Clinical Trial Description

Lp(a) levels play an important role in predicting subsequent ischemic events in patients with established coronary artery disease (CAD), especially those who underwent PCI. However, there are still no approved pharmacologic therapies that specifically target high Lp(a) levels.

DAPT consisting of aspirin and a P2Y12 receptor inhibitor represents the cornerstone of pharmacological treatment aimed at preventing thrombotic complications after PCI. Considering that Lp(a) has a prothrombotic effect through its inactive, plasminogen-like protease domain on apo(a), the investigators speculate that prolonged DAPT may have a beneficial effect on reducing future ischemic events in patients with elevated Lp(a) levels after PCI. Some observational studies revealed that DAPT > 1 year was significantly associated with lower risk of cardiovascular events compared with DAPT ≤ 1 year in patients with elevated Lp(a) levels who were event-free at 1 year after PCI with DES. However, the relative efficacy and safety of prolonged DAPT versus standard DAPT in this high-risk population has never been assessed in randomized controlled trials (RCTs).

The DAPT-Lp(a) trial is a multicenter, parallel-group, randomized controlled trial with blinded end-point evaluation. Consecutive patients with Lp(a) levels>30mg/dL who meet the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 fashion to 24-month DAPT group or 12-month DAPT group. The investigators hypothesise that, in patients with Lp(a) levels >30mg/dL who were event-free at 1 year after PCI with DES, 24-month DAPT is superior to 12-month DAPT with respect to major adverse cardiovascular and cerebrovascular events (primary end point), while it is non-inferior to 12-month DAPT with respect to net adverse clinical events (key secondary end point).

The investigators estimated that 3,300 patients would be needed to provide the necessary number of confirmed endpoints to test the study hypothesis. Patients will be followed up at 3, 6, 9, 12 months after randomization. All analyses will be performed according to the intention-to-treat (ITT) principle. ;

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Drug-Eluting Stent
• Dual Antiplatelet Therapy
• Myocardial Ischemia

• NCT number: NCT06014060
• Study type: Interventional
• Source: China National Center for Cardiovascular Diseases
• Contact: Kefei Dou, MD, PhD
• Phone: +86-10-13801032912
• Email: drdoukefei@126.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Completion date: December 31, 2028