Optical Coherence Tomography to Evaluate Ticagrelor and Clopidogrel

Study Overview
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Brief Summary
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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
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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%.

Official Title
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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

Conditions
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Thrombosis

Intervention / Treatment
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* Drug: Ticagrelor
* Drug: Clopidogrel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ticagrelor<br>Ticagrelor 90mg tablet, twice daily | Drug: Clopidogrel<br>* Orange brown capsule, containing one 75 mg clopidogrel tablet (cut into 2 halves)<br>* Other names: Plavix®;|
| Experimental: Clopidogrel<br>Clopidogrel 75mg tablet, daily | Drug: Ticagrelor<br>* Plain, round, yellow, filmcoated tablet, 90 mg<br>* Other names: BRILINTA™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subclinical thrombus | The occurrence of subclinical thrombus as detected by OCT | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous coronary intervention, Drug-eluting stent, Thrombosis