Thrombosis
Conditions
Keywords
Percutaneous coronary intervention, Drug-eluting stent, Thrombosis
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%.
Interventions
DRUGTicagrelor
Plain, round, yellow, filmcoated tablet, 90 mg
DRUGClopidogrel
Orange brown capsule, containing one 75 mg clopidogrel tablet (cut into 2 halves)
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subclinical thrombus | 12 months | The occurrence of subclinical thrombus as detected by OCT |
Secondary
| Measure | Time frame |
|---|---|
| Endothelial coverage of the stent struts assessed by optical coherence tomography | 12 months |
| Neointimal proliferation within the stent assessed by optical coherence tomography | 12 months |
| Stent malposition assessed by optical coherence tomography | 12 months |
| Edge dissections assessed by optical coherence tomography | 12 months |
Other
| Measure | Time frame |
|---|---|
| Bleeding events | 12 months |
Countries
China
Outcome results
None listed