Optical Coherence Tomography to Evaluate Ticagrelor and Clopidogrel

Nanjing Medical University

Status and phase

Completed

Phase 4

Conditions

Thrombosis

Treatments

Drug: Clopidogrel

Drug: Ticagrelor

Study type

Interventional

Funder types

Other

Identifiers

NCT02140801

ISSBRIL0361

Details and patient eligibility

About

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).

Full 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%.

Enrollment

352 patients

Sex

All

Ages

18+ years old

Volunteers

No 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