Optical Coherence Tomography to Evaluate Ticagrelor and Clopidogrel
- Registration Number
- NCT02140801
- Brief Summary
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).
- Detailed Description
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%.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 352
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ticagrelor Clopidogrel Ticagrelor 90mg tablet, twice daily Clopidogrel Ticagrelor Clopidogrel 75mg tablet, daily
- Primary Outcome Measures
Name Time Method Subclinical thrombus 12 months The occurrence of subclinical thrombus as detected by OCT
- Secondary Outcome Measures
Name Time Method Endothelial coverage of the stent struts assessed by optical coherence tomography 12 months Edge dissections assessed by optical coherence tomography 12 months Stent malposition assessed by optical coherence tomography 12 months Neointimal proliferation within the stent assessed by optical coherence tomography 12 months
Trial Locations
- Locations (1)
Nanjing First Hospital
🇨🇳Nanjing, Jiangsu, China