Optical Coherence Tomography to Evaluate Ticagrelor and Clopidogrel

• Status: Completed
• Trial end date: 2017-03-08
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University; The First Affiliated Hospital with Nanjing Medical University
• Treatments: Clopidogrel; Ticagrelor; Ticlopidine

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