Optical Coherence Tomography to Evaluate Ticagrelor and Clopidogrel

• Sponsor: Nanjing First Hospital, Nanjing Medical University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02140801
• Collaborator: (none)
• Enrollment: 352
• Location: 1
• Arms: 2
• Duration (Months): 34.2
• Patients Per Site Per Month: 10.3

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Thrombosis	Drug: Ticagrelor; Drug: Clopidogrel	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 352 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: May 1, 2014
• Actual Primary Completion Date: Mar 8, 2017
• Actual Study Completion Date: Mar 8, 2017

Arms and Interventions

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™

Outcome Measures

Primary Outcome Measures

1. Subclinical thrombus [12 months]

   The occurrence of subclinical thrombus as detected by OCT

Secondary Outcome Measures

1. Endothelial coverage of the stent struts assessed by optical coherence tomography [12 months]

2. Neointimal proliferation within the stent assessed by optical coherence tomography [12 months]

3. Stent malposition assessed by optical coherence tomography [12 months]

4. Edge dissections assessed by optical coherence tomography [12 months]

Other Outcome Measures

1. Bleeding events [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nanjing First Hospital	Nanjing	Jiangsu	China	210006

Sponsors and Collaborators

• Nanjing First Hospital, Nanjing Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shaoliang Chen, Vice President, Nanjing First Hospital, Nanjing Medical University
• ClinicalTrials.gov Identifier: NCT02140801
• Other Study ID Numbers: ISSBRIL0361
• First Posted: May 16, 2014
• Last Update Posted: Mar 21, 2018
• Last Verified: Mar 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Shaoliang Chen, Vice President, Nanjing First Hospital, Nanjing Medical University: Percutaneous coronary intervention; Drug-eluting stent; Thrombosis
• Additional relevant MeSH terms: Thrombosis; Clopidogrel; Ticagrelor

Study Results

No Results Posted as of Mar 21, 2018