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Effect of Ticagrelor Versus Clopidogrel on Endothelial Dysfunction and Vascular Inflammation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02379676
Recruitment Status : Unknown
Verified July 2016 by Kiyuk Chang, Seoul St. Mary's Hospital.
Recruitment status was:  Recruiting
First Posted : March 5, 2015
Last Update Posted : July 6, 2016
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Kiyuk Chang, Seoul St. Mary's Hospital

Brief Summary:

The purpose of this study is to compare the effects of ticagrelor and clopidogrel on endothelial dysfunction and vascular inflammation

Ticagrelor will lead to beneficial pleiotropic effects compared with treatment with clopidogrel in patients receiving a drug-eluting stents (DES) during percutaneous coronary intervention (PCI) for non-ST-segment acute coronary syndrome (NSTE-ACS) beyond 1 month after the index event. Ticagrelor treatment will improve percent flow-mediated dilation (FMD) values and reduces inflammatory gene expression on peripheral blood mononuclear cells.


Condition or disease Intervention/treatment Phase
Endothelial Dysfunction Vascular Inflammation Drug: Ticagrelor Drug: Clopidogrel Phase 4

Detailed Description:

The primary objective of this study lies in whether ticagrelor improves endothelial dysfunction compared to clopidogrel, measured by endothelium-dependent flow-mediated dilation (FMD). The secondary objective is to demonstrate whether ticagrelor has an anti-atherosclerotic effect compared to clopidogrel in terms of reducing systemic low-grade inflammation. Endpoints are 1) difference of flow-mediated dilation values, and 2) messenger ribonucleic acid (mRNA) expression measured by quantitative real-time reverse transcription-polymerase chain reaction (qRT-PCR) of inflammation-associated key genes in circulation monocytes between non-ST-segment acute coronary syndrome patients treated with ticagrelor and clopidogrel.

Patients who agree to participate study are screened at Visit 1 (30 ~ 365 days after index percutaneous coronary intervention). Patients with endothelial dysfunction defined as screening flow-mediated dilation are randomly assigned at Visit 2 (0~7 days after screening test). And then, patients should receive study drugs according to allocated groups from the day of randomization. Ticagrelor 90mg twice daily or clopidogrel 75mg daily will be maintained for 30 days. Flow-mediated dilation are performed at screening and at Visit 3 (day 30 from the treatment of study drugs) and blood sampling are performed before the first dose of study drugs at Visit 2 and at Visit 3.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of the Effects of Ticagrelor Versus Clopidogrel on Endothelial Dysfunction and Vascular Inflammation in Patients With Prior Non-ST-segment Acute Coronary Syndrome
Study Start Date : January 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ticagrelor
Ticagrelor 90mg twice daily
Drug: Ticagrelor
Ticagrelor 90mg twice daily for 30 days

Active Comparator: Clopidogrel
Clopidogrel 75mg once daily
Drug: Clopidogrel
Clopidogrel 75mg once daily for 30 days




Primary Outcome Measures :
  1. Change in percent flow-mediated dilation (FMD) values [ Time Frame: Baseline, 30 days ]

Secondary Outcome Measures :
  1. Percent flow-mediated dilation (FMD) values [ Time Frame: Baseline, 30 days ]
  2. Incidence rate of patient with percent flow-mediated dilation (FMD) value less than 7% [ Time Frame: Baseline, 30 days ]
  3. Inflammatory gene expression levels by quantitative real-time reverse transcription-polymerase chain reaction (qRT-PCR) [ Time Frame: Baseline, 30 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 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 ≥20 years of age
  • Documented history of non-ST-segment acute coronary syndrome occurring 30 ~ 365 days prior to randomization and successfully treated with percutaneous coronary intervention using drug-eluting stent
  • Patient currently prescribed and tolerating aspirin 100mg and clopidogrel 75mg.
  • Patient who have demonstrated endothelial dysfunction defined as percent flow-mediated dilation values lower than 7% at baselines test

Exclusion Criteria:

  • Patients with angina related symptoms
  • Patients who did not undergo or failed invasive treatment
  • Patients with a history of hypersensitivity to ticagrelor or clopidogrel
  • Patients who took an anti-coagulant, anti-thrombotic regularly before the study, or plan to have continuous treatment during the study
  • Patients who took vasoactive agents or caffeine ingestion for <48
  • Patients with decompensated congestive heart failure of cardiogenic shock (Killip classification III or IV)
  • Patients with intractable arrhythmia
  • Patients with intractable arrhythmia
  • Patients with second or third degree atrioventricular block
  • Patients with uncontrolled hypertension
  • Patients with high risk of hemorrhage like blood coagulation disorders, gastrointestinal bleeding, gross hematuria, intraocular bleeding, hemorrhagic stroke, intracranial hemorrhage
  • Patients with more than moderate chronic obstructive pulmonary disease diagnosed by symptoms or documented by pulmonary function test
  • Patients who required renal replacement therapy
  • Patients with moderate to severe hepatic impairment
  • Patients with platelet <100,000/μL
  • Patients with hematocrit <30%
  • Concomitant oral or parenteral therapy with strong cytochrome P450 3A4 inhibitors, cytochrome P450 3A substrates with narrow therapeutic indices, or strong cytochrome P450 3A4 inducers i) Strong inhibitors: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin (but not erythromycin or azithromycin), nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atanazavir, over 1 litre daily of grapefruit juice ii) Substrates with narrow therapeutic index: cyclosporine, quinidine, simvastatin at doses >40 mg daily or lovastatin at doses >40 mg daily iii) Strong inducers: rifampin/rifampicin, rifabutin, phenytoin, carbamazepine, phenobarbital
  • Patient who need to take drugs other than study medications and allowed concomitant medications during study period.
  • Patients who have planned elective surgery or invasive procedure requiring temporary discontinued study medication during study period.
  • Patients who are pregnant, breast feeding and not using medically acceptable birth control.
  • Patients considered as unsuitable based on medical judgment by investigators.

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): NCT02379676


Contacts
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Contact: Kiyuk Chang, MD, PhD 82-2-2258-1139 kiyuk@catholic.ac.kr
Contact: Sungmin Lim, MD 82-2-2258-1139 sungmin@catholic.ac.kr

Locations
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Korea, Republic of
Seoul St. Mary's Hospital, The Catholic University of Korea Recruiting
Seoul, Korea, Republic of
Contact: Kiyuk Chang, MD, PhD    82-2-2258-1139    kiyuk@catholic.ac.kr   
Contact: Sungmin Lim, MD    82-2-2258-1139    sungmin@catholic.ac.kr   
Principal Investigator: Kiyuk Chang, MD, PhD         
Sub-Investigator: Sungmin Lim, MD         
Sub-Investigator: Eun Ho Choo, MD         
Sponsors and Collaborators
Kiyuk Chang
AstraZeneca
Investigators
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Principal Investigator: Kiyuk Chang, MD, PhD Seoul St. Mary's Hospital, The Catholic.University of Korea

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Responsible Party: Kiyuk Chang, Chief of the divison of cardiology, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT02379676    
Other Study ID Numbers: XC14MIMI0092k
First Posted: March 5, 2015    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes
Clopidogrel
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