Coronary Artery Disease Clinical Trial
Official title:
Randomized-controlled Trial of a Combined vs. Conventional Percutaneous Intervention for Near-Infrared Spectroscopy Defined High-Risk Native Coronary Artery Lesions
Design: Single center, single-blind randomized controlled trial of patients with high risk
native coronary artery lesions (defined as ≥2 contiguous yellow blocks on the block
chemogram) requiring clinically indicated percutaneous coronary intervention. Patients will
be randomized to either a combined intervention or conventional PCI. Cardiac biomarker
measurements will be performed before PCI and 18-24 hours later.
Treatment: Combined intervention consisting of pre-PCI intracoronary vasodilator and
glycoprotein IIb/IIIa inhibitor administration, use of an EPD if technically feasible, and
complete coverage of the lipid core plaque, if technically feasible.
Control: Conventional PCI. Duration: 30 days follow-up. The primary trial objective is to
compare the incidence and size of periprocedural MI, as assessed by the peak post-PCI
troponin distribution in the two study groups.
The secondary endpoints are: (1) Reduction in the incidence of >3x and >10x upper limit of
normal increase in CK-MB. (2) Reduction in the incidence of slow flow/no-reflow post PCI.
(3) Lower incidence of major adverse cardiac events, defined as the composite of death,
acute coronary syndrome, or coronary revascularization) during 30-day follow-up.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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