Optical Coherence Tomography to Evaluate Ticagrelor and Clopidogrel

Thrombosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02140801
• Other study ID #: ISSBRIL0361
• Status: Completed
• Phase: Phase 4
• First received: May 14, 2014
• Last updated: March 20, 2018
• Start date: May 1, 2014
• Est. completion date: March 8, 2017

Study information

• Verified date: March 2018
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 352
• Est. completion date: March 8, 2017
• Est. primary completion date: March 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thrombosis

Intervention

Drug:
• Ticagrelor
Plain, round, yellow, filmcoated tablet, 90 mg
• Clopidogrel
Orange brown capsule, containing one 75 mg clopidogrel tablet (cut into 2 halves)

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bleeding events		12 months
Primary	Subclinical thrombus	The occurrence of subclinical thrombus as detected by OCT	12 months
Secondary	Endothelial coverage of the stent struts assessed by optical coherence tomography		12 months
Secondary	Neointimal proliferation within the stent assessed by optical coherence tomography		12 months
Secondary	Stent malposition assessed by optical coherence tomography		12 months
Secondary	Edge dissections assessed by optical coherence tomography		12 months