Optical Coherence Tomography to Evaluate Ticagrelor and Clopidogrel

A Randomised, Open-label, Parallel Group, Multi-center Study Using OCT to Comparing the Efficacy and Safety of Ticagrelor With Clopidogrel in the Prevention of Subclinical Thrombus in Patients After Drug-eluting Stent Implantation

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%.

Inclusion Criteria:

• Provision of informed consent prior to any study specific procedures;
• Men and women 18 years and older;.
• Established indication to PCI according to the guidelines of American Heart Association and American College of Cardiology;
• Native coronary lesion suitable for drug-eluting stent placement and OCT imaging.

Exclusion Criteria:

• Pregnancy and breast feeding mother;
• Co-morbidity with an estimated life expectancy of < 50 % at 12 months;
• Scheduled major surgery in the next 6 months;
• Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk;
• Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 30 days
• Cardiogenic shock
• Previous subacute or late coronary stent thrombosis
• Known allergy against ticagrelor, or against clopidogrel, or aspirin
• History of major hemorrhage (intracranial, gastrointestinal, etc.)
• Active pathological bleeding
• Acute or chronic hematologic disorder including a Hemoglobin less than 10 g/L or a platelet count less than 10×109/L before procedure
• Any history of Severe renal or hepatic dysfunction (hepatic failure, cirrhosis, portal hypertension and active hepatitis);
• Neutropenia,
• thrombocytopenia;
• Known acute pancreatitis
• Arterial aneurysm, arterial/venous malformation and aorta dissection.
• Culprit lesion within the proximal 10 mm of the right or left coronary artery
• Saphenous vein grafts
• Lesion length > 30 mm
• Involves a side branch ≥2.0 mm in diameter by visual estimate which requires treatment
• In-stent restenotic lesions
• Thombus-containing lesions