A number of 352 patients scheduled for elective percutaneous coronary intervention (PCI) with a native coronary stenosis suitable for DES implantation and OCT imaging are openly randomized 1:1 to either BRILINTA™ (ticagrelor) or Plavix® (clopidogrel bisulfate).
The study is prospectively conducted at 4 high-volume PCI center in China with OCT expertise. Angiographic follow-up and OCT imaging with motorized pull-back at 20-36 mm/s are planned in all patients 12 months after implantation of the study stents. OCT endpoints are: (1) Subclinical intra-stent thrombus, defined as a mass protruding to the lumen with significant attenuation, and respectively (2) endothelial coverage, expressed as % of struts without coverage and % of stent length containing non-covered struts. The study is powered for OCT endpoints, which are likely to reach significance at the level P \< 0.05 even at a follow-up drop-out rate up to 10%.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
352
Plain, round, yellow, filmcoated tablet, 90 mg
Orange brown capsule, containing one 75 mg clopidogrel tablet (cut into 2 halves)
Nanjing First Hospital
Nanjing, Jiangsu, China
Subclinical thrombus
The occurrence of subclinical thrombus as detected by OCT
Time frame: 12 months
Endothelial coverage of the stent struts assessed by optical coherence tomography
Time frame: 12 months
Neointimal proliferation within the stent assessed by optical coherence tomography
Time frame: 12 months
Stent malposition assessed by optical coherence tomography
Time frame: 12 months
Edge dissections assessed by optical coherence tomography
Time frame: 12 months
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