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).

Study Overview

• Status: Completed
• Conditions: Thrombosis
• Intervention / Treatment: Drug: Clopidogrel; Drug: Ticagrelor

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%.

• Study Type: Interventional
• Enrollment (Actual): 352
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210006
      • Nanjing First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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	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 Outcome Measures

Outcome Measure	Time Frame
Bleeding events	12 months

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University
• Investigators: Principal Investigator: Shaoliang Chen, MD, The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): March 8, 2017
• Study Completion (Actual): March 8, 2017

Study Registration Dates

• First Submitted: May 14, 2014
• First Submitted That Met QC Criteria: May 14, 2014
• First Posted (Estimate): May 16, 2014

Study Record Updates

• Last Update Posted (Actual): March 21, 2018
• Last Update Submitted That Met QC Criteria: March 20, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Thrombosis; Percutaneous coronary intervention; Drug-eluting stent
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Ticagrelor; Clopidogrel
• Other Study ID Numbers: ISSBRIL0361

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes