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Optical Coherence Tomography to Evaluate Ticagrelor and Clopidogrel

Primary Purpose

Thrombosis

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Ticagrelor
Clopidogrel
Sponsored by
Nanjing First Hospital, Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thrombosis focused on measuring Percutaneous coronary intervention, Drug-eluting stent, Thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nanjing First Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ticagrelor

Clopidogrel

Arm Description

Ticagrelor 90mg tablet, twice daily

Clopidogrel 75mg tablet, daily

Outcomes

Primary Outcome Measures

Subclinical thrombus
The occurrence of subclinical thrombus as detected by OCT

Secondary Outcome Measures

Endothelial coverage of the stent struts assessed by optical coherence tomography
Neointimal proliferation within the stent assessed by optical coherence tomography
Stent malposition assessed by optical coherence tomography
Edge dissections assessed by optical coherence tomography

Full Information

First Posted
May 14, 2014
Last Updated
March 20, 2018
Sponsor
Nanjing First Hospital, Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02140801
Brief Title
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

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2014 (undefined)
Primary Completion Date
March 8, 2017 (Actual)
Study Completion Date
March 8, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis
Keywords
Percutaneous coronary intervention, Drug-eluting stent, Thrombosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
352 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ticagrelor
Arm Type
Experimental
Arm Description
Ticagrelor 90mg tablet, twice daily
Arm Title
Clopidogrel
Arm Type
Experimental
Arm Description
Clopidogrel 75mg tablet, daily
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Other Intervention Name(s)
BRILINTA™
Intervention Description
Plain, round, yellow, filmcoated tablet, 90 mg
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Other Intervention Name(s)
Plavix®
Intervention Description
Orange brown capsule, containing one 75 mg clopidogrel tablet (cut into 2 halves)
Primary Outcome Measure Information:
Title
Subclinical thrombus
Description
The occurrence of subclinical thrombus as detected by OCT
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Endothelial coverage of the stent struts assessed by optical coherence tomography
Time Frame
12 months
Title
Neointimal proliferation within the stent assessed by optical coherence tomography
Time Frame
12 months
Title
Stent malposition assessed by optical coherence tomography
Time Frame
12 months
Title
Edge dissections assessed by optical coherence tomography
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Bleeding events
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaoliang Chen, MD
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35939981
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.
Results Reference
derived
PubMed Identifier
32326796
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.
Results Reference
derived

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Optical Coherence Tomography to Evaluate Ticagrelor and Clopidogrel

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