NCT02140801

Optical Coherence Tomography to Evaluate Ticagrelor and Clopidogrel

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 352 (actual)
• Sponsor: Nanjing First Hospital, Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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%.

Conditions

• Thrombosis

Interventions

Type	Name	Description
DRUG	Ticagrelor	Plain, round, yellow, filmcoated tablet, 90 mg
DRUG	Clopidogrel	Orange brown capsule, containing one 75 mg clopidogrel tablet (cut into 2 halves)

Timeline

• Start date: 2014-05-01
• Primary completion: 2017-03-08
• Completion: 2017-03-08
• First posted: 2014-05-16
• Last updated: 2018-03-21

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study