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Trial record 86 of 1050 for:    clopidogrel

Optical Coherence Tomography to Evaluate Ticagrelor and Clopidogrel

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ClinicalTrials.gov Identifier: NCT02140801
Recruitment Status : Completed
First Posted : May 16, 2014
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
Shaoliang Chen, Nanjing First Hospital, Nanjing Medical University

Brief 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).

Condition or disease Intervention/treatment Phase
Thrombosis Drug: Ticagrelor Drug: Clopidogrel Phase 4

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%.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 352 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : May 1, 2014
Actual Primary Completion Date : March 8, 2017
Actual Study Completion Date : March 8, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

Arm Intervention/treatment
Experimental: Ticagrelor
Ticagrelor 90mg tablet, twice daily
Drug: Clopidogrel
Orange brown capsule, containing one 75 mg clopidogrel tablet (cut into 2 halves)
Other Name: Plavix®

Experimental: Clopidogrel
Clopidogrel 75mg tablet, daily
Drug: Ticagrelor
Plain, round, yellow, filmcoated tablet, 90 mg
Other Name: BRILINTA™




Primary Outcome Measures :
  1. Subclinical thrombus [ Time Frame: 12 months ]
    The occurrence of subclinical thrombus as detected by OCT


Secondary Outcome Measures :
  1. Endothelial coverage of the stent struts assessed by optical coherence tomography [ Time Frame: 12 months ]
  2. Neointimal proliferation within the stent assessed by optical coherence tomography [ Time Frame: 12 months ]
  3. Stent malposition assessed by optical coherence tomography [ Time Frame: 12 months ]
  4. Edge dissections assessed by optical coherence tomography [ Time Frame: 12 months ]

Other Outcome Measures:
  1. Bleeding events [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02140801


Locations
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China, Jiangsu
Nanjing First Hospital
Nanjing, Jiangsu, China, 210006
Sponsors and Collaborators
Nanjing First Hospital, Nanjing Medical University
Investigators
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Principal Investigator: Shaoliang Chen, MD The First Affiliated Hospital with Nanjing Medical University

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Responsible Party: Shaoliang Chen, Vice President, Nanjing First Hospital, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT02140801     History of Changes
Other Study ID Numbers: ISSBRIL0361
First Posted: May 16, 2014    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Shaoliang Chen, Nanjing First Hospital, Nanjing Medical University:
Percutaneous coronary intervention
Drug-eluting stent
Thrombosis
Additional relevant MeSH terms:
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Clopidogrel
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs