Clinical trial NCT02140801: Optical Coherence Tomography to Evaluate Ticagrelor and Clopidogrel
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Thrombosis
Keywords: Percutaneous coronary intervention
Drug-eluting stent
Thrombosis
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2014-05-16
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.

Eligibility criteria: 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

Primary outcomes:
measure: Subclinical thrombus
timeFrame: 12 months
Secondary outcomes:
measure: Endothelial coverage of the stent struts assessed by optical coherence tomography
timeFrame: 12 months
measure: Neointimal proliferation within the stent assessed by optical coherence tomography
timeFrame: 12 months
measure: Stent malposition assessed by optical coherence tomography
timeFrame: 12 months
measure: Edge dissections assessed by optical coherence tomography
timeFrame: 12 months
Other outcomes:
measure: Bleeding events
timeFrame: 12 months
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Shaoliang Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nong JC, You W, Xu T, Meng PN, Xu Y, Wu XQ, Wu ZM, Tao BL, Guo YJ, Yang S, Yin DL, Ye F. Dynamic natural morphologies and component changes in nonculprit subclinical atherosclerosis in patients with acute coronary syndrome at 1-year follow-up and clinical significance at 3-year follow-up. Atherosclerosis. 2022 Sep;356:1-8. doi: 10.1016/j.atherosclerosis.2022.07.013. Epub 2022 Jul 31.
citation: Wu X, You W, Wu Z, Wu Q, Jiang J, Yan H, Ye F, Chen S. Ticagrelor versus clopidogrel for prevention of subclinical stent thrombosis detected by optical coherence tomography in patients with drug-eluting stent implantation-a multicenter and randomized study. Platelets. 2021 Apr 3;32(3):404-412. doi: 10.1080/09537104.2020.1754381. Epub 2020 Apr 24.