Optical Coherence Tomography to Evaluate Ticagrelor and Clopidogrel

NCT02140801 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: ISSBRIL0361
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

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).

Conditions

Thrombosis

Keywords

Percutaneous coronary intervention; Drug-eluting stent; Thrombosis

Outcome Measures

Primary Outcomes (1)

• Subclinical thrombus

  The occurrence of subclinical thrombus as detected by OCT

  12 months

Secondary Outcomes (4)

• 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 Outcomes (1)

• Bleeding events

  12 months

Study Arms (2)

Ticagrelor

EXPERIMENTAL

Ticagrelor 90mg tablet, twice daily

Drug: Clopidogrel

Clopidogrel

EXPERIMENTAL

Clopidogrel 75mg tablet, daily

Drug: Ticagrelor

Interventions

Ticagrelor DRUG

Plain, round, yellow, filmcoated tablet, 90 mg

Also known as: BRILINTA™

Clopidogrel

Clopidogrel DRUG

Orange brown capsule, containing one 75 mg clopidogrel tablet (cut into 2 halves)

Also known as: Plavix®

Ticagrelor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location

Related Publications (5)

• Xu Y, Wang YF, Zhao MY, You W, Xu T, Meng PN, Wu XQ, Wu ZM, Kong XH, Yin DL, Zhan ME, Jia HB, Liu B, Ye F. Study on the potential clinical significance of subclinical stent edge effects after drug-eluting stent implantation. Sci Rep. 2025 Mar 10;15(1):8258. doi: 10.1038/s41598-024-81329-7.

  PMID: 40064903 DERIVED

• Nong JC, You W, Wang YF, Xu Y, Xu T, Meng PN, Wu XQ, Wu ZM, Kong XH, Jia HB, Yin DL, Li L, Ye F. Dynamic natural components and morphological changes in nonculprit subclinical atherosclerosis in patients with acute coronary syndrome and mild chronic kidney disease at the 1-year follow-up and clinical significance at the 5-year follow-up. PLoS One. 2024 May 31;19(5):e0302547. doi: 10.1371/journal.pone.0302547. eCollection 2024.

  PMID: 38820294 DERIVED

• Meng PN, Nong JC, Xu Y, You W, Xu T, Wu XQ, Wu ZM, Tao BL, Guo YJ, Yin DL, Jia HB, Yang S, Ye F. Morphologies and composition changes in nonculprit subclinical atherosclerosis in diabetic versus nondiabetic patients with acute coronary syndrome who underwent long-term statin therapy. Sci Rep. 2023 Apr 1;13(1):5338. doi: 10.1038/s41598-023-32638-w.

  PMID: 37005448 DERIVED

• 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.

  PMID: 35939981 DERIVED

• 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.

  PMID: 32326796 DERIVED

MeSH Terms

Conditions

Thrombosis

Interventions

Ticagrelor; Clopidogrel

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Shaoliang Chen, MD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President

Study Record Dates

• First Submitted: May 14, 2014
• First Posted: May 16, 2014
• Study Start: May 1, 2014
• Primary Completion: March 8, 2017
• Study Completion: March 8, 2017
• Last Updated: March 21, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)