Optical Coherence Tomography to Evaluate Ticagrelor and Clopidogrel

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

352 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-01

Study Completion Date

2017-03-08

Brief Summary

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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).

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Detailed Description

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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

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Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Ticagrelor

Ticagrelor 90mg tablet, twice daily

Group Type EXPERIMENTAL

Clopidogrel

Intervention Type DRUG

Orange brown capsule, containing one 75 mg clopidogrel tablet (cut into 2 halves)

Clopidogrel

Clopidogrel 75mg tablet, daily

Group Type EXPERIMENTAL

Ticagrelor

Intervention Type DRUG

Plain, round, yellow, filmcoated tablet, 90 mg

Interventions

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Ticagrelor

Plain, round, yellow, filmcoated tablet, 90 mg

Intervention Type DRUG

Clopidogrel

Orange brown capsule, containing one 75 mg clopidogrel tablet (cut into 2 halves)

Intervention Type DRUG

Other Intervention Names

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BRILINTA™ Plavix®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No