Comparison of The Influence of Ticagrelor And Clopidogrel on Inflammatory Biomarkers And Vascular Endothelial Function (Brilinta)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Jinan Central Hospital
Sponsor:
Information provided by (Responsible Party):
Su Guohai, Jinan Central Hospital
ClinicalTrials.gov Identifier:
NCT02123004
First received: April 20, 2014
Last updated: April 23, 2014
Last verified: April 2014
  Purpose
  1. Ticagrelor inhibits inflammation and improves vascular endothelial cell function to a greater extent than clopidogrel in ST-segment elevation myocardial infarction(STEMI) patients receiving percutaneous coronary intervention.
  2. Ticagrelor can reduce the serum levels of inflammatory biomarkers both in coronary and in peripheral venous in patients with ST-segment elevation myocardial infarction(STEMI).

Condition Intervention Phase
ST-Segment Elevation Myocardial Infarction
Drug: Ticagrelor
Drug: Clopidogrel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of The Influence of Ticagrelor And Clopidogrel on Inflammatory Biomarkers And Vascular Endothelial Function For Patients With ST-Segment Elevation Myocardial Infarction Receiving Emergency Percutaneous Coronary Intervention

Resource links provided by NLM:


Further study details as provided by Jinan Central Hospital:

Primary Outcome Measures:
  • CD40 Ligand(CD40l)/C-reactive protein(CRP)/P-selectin and Circulating Endothelial Cells(CECs) [ Time Frame: 0 -4 weeks ] [ Designated as safety issue: No ]
    The peripheral venous serum level of CD40 Ligand(CD40l)/C-reactive protein(CRP)/P-selectin and Circulating Endothelial Cells(CECs), 0 hour after dosing and 4 weeks after Percutaneous Coronary Intervention(PCI).


Secondary Outcome Measures:
  • CD40 Ligand(CD40l)/C-reactive protein(CRP)/P-selectin and Circulating Endothelial Cells(CECs) [ Time Frame: 24hour after dosing ] [ Designated as safety issue: No ]
    The peripheral venous serum level of CD40 Ligand(CD40l)/C-reactive protein(CRP)/P-selectin and Circulating Endothelial Cells(CECs), 24hour after dosing and 1 weeks after Percutaneous Coronary Intervention(PCI);

  • CD40 Ligand(CD40l)/C-reactive protein(CRP)/P-selectin and Circulating Endothelial Cells(CECs) [ Time Frame: 1 weeks after Percutaneous Coronary Intervention ] [ Designated as safety issue: No ]
    The peripheral venous serum level of CD40 Ligand(CD40l)/C-reactive protein(CRP)/P-selectin and Circulating Endothelial Cells(CECs),24hour after dosing and 1 weeks after Percutaneous Coronary Intervention(PCI);

  • CD40 Ligand(CD40l)/C-reactive protein(CRP)/P-selectin and Circulating Endothelial Cells(CECs) [ Time Frame: 1 hour after dosing ] [ Designated as safety issue: No ]
    the coronary serum level of CD40 Ligand(CD40l)/C-reactive protein(CRP)/P-selectin and Circulating Endothelial Cells(CECs),1 hour after dosing;


Other Outcome Measures:
  • Adverse Event [ Time Frame: during 4 weeks follow up ] [ Designated as safety issue: Yes ]
    The safety objective of this study in patients will be evaluated by the occurrence of any Adverse Event(AEs) during 4 weeks follow up.Suspected bleeding/reinfarction /rehospitalization /revascularization by Percutaneous Coronary Intervention(PCI) or coronary artery bypass graft (CABG) / sudden death/ stoke /allergic or allergic-like reactions and other adverse events and serious adverse events.


Estimated Enrollment: 350
Study Start Date: April 2014
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ticagrelor

Investigational product/Dosage form and strength/Manufacturer:

ticagrelor/tablet /90mg/AstraZeneca 180mg loading dose for one day ,then 90mg per day for 4 weeks

Drug: Ticagrelor
180mg loading dose for one day ,and then 90mg per day for 4 weeks
Other Name: Brilinta
Active Comparator: Clopidogrel

Investigational product/Dosage form and strength/Manufacturer:

clopidogrel/tablet /75mg/Sanofi 300mg loading dose for one day ,then 75mg per day for 4 weeks

Drug: Clopidogrel
300mg loading dose for one day ,and then 75mg per day for 4 weeks
Other Name: plavix

Detailed Description:

Platelet participates in the process of forming and extending atherosclerotic plaques, and it is also a source of inflammatory mediators. This study is a randomized, open-label study, designed to test the hypothesis that ticagrelor inhibits inflammation and improves vascular endothelial cell function to a greater extent than clopidogrel in ST-segment elevation myocardial infarction(STEMI) patients receiving percutaneous coronary intervention. Patients who are scheduled to undergo emergency Percutaneous Coronary Intervention(PCI) will be randomly assigned to receive ticagrelor 180mg for treatment group or clopidogrel 600mg for control group ,then after Percutaneous Coronary Intervention(PCI) treatment group treated with ticagrelor 90mg twice daily while the control group received clopidogrel 75mg once a day . All patients should receive Acetylsalicylic Acid(ASA) 300 mg as a loading dose before Percutaneous Coronary Intervention(PCI) then 100 mg daily unless intolerant. Glycoprotein Ⅱb/Ⅲa receptor antagonists and low-molecular-weight heparin and other additional medication will be directed by the treating cardiologist. All interventions will be performed via the radial approach with the standard technique within 12h after they are involved, and drug-eluting stents will be placed according to stenosis of coronary artery.

The vascular endothelial function will be tested by Circulating Endothelial Cells (CECs) and levels of inflammation will be tested by CD40 ligand (CD40L), C-reactive protein (CRP), and P-selectin to identify that ticagrelor inhibits inflammation and improves vascular endothelial cell function to a greater extent than clopidogrel.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or non-pregnant female.
  2. Age ≥ 18 years old and <80 years old.
  3. Consecutive patients who should be hospitalized with documented evidence of ST-Segment Elevation Myocardial Infarction receiving Percutaneous Coronary Intervention.
  4. All patients havepersistent≥0.2 Millivolt ST segment elevation in two or more contiguous precordial leads or ≥0.1 Millivolt ST elevation in two or more contiguous limb leads, with one of the following: persistent chest pain or elevatory of biomarkers of myocardial necrosis.
  5. Time from chest pain onset to receiving Percutaneous Coronary Intervention <12 hours.
  6. Persistent chest pain <12 hours.
  7. Provision of informed consent prior to any study specific procedures.

Exclusion Criteria:

  1. Involved in other trials.
  2. In recent one year have P 2 Y 12 receptor antagonist drug treatment history or long-term use of immunosuppressive agents.
  3. Recurrent myocardial infarction or previous history of Coronary Artery Bypass Graft(CABG) surgery or rescue Percutaneous Coronary Intervention.
  4. Active bleeding or bleeding history.
  5. With obvious infection and body temperature (axillary temperature) higher than 38.0 ℃.
  6. Autoimmune diseases.
  7. Malignancies.
  8. In recent 6 months have received major surgery.
  9. Left ventricular ejection fraction is less than 30%.
  10. Life expectancy less than one year.
  11. With moderate and severe liver function deterioration.
  12. End-stage renal failure.
  13. Other conditions that may put the patient at risk or influence study results in the investigators' opinion:eg, increased risk of bradycardiac events; known clinically important thrombocytopenia; known clinically important anemia; severe hemodynamic instability.
  14. Other contraindications to investigate products.
  15. Any condition that increases the risk for noncompliance or being lost to follow-up.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02123004

Contacts
Contact: Su Guohai, Doctor +86(0)13370582008 guohaisu@medmail.com.cn

Locations
China, Shandong
Jinan Central Hospital Not yet recruiting
Jinan Shi, Shandong, China, 250013
Contact: Su Guohai, Doctor    +86(0)13370582008    guohaisu@medmail.com.cn   
Contact: Li Zhenhua, Doctor    +86(0)13969081430    lizhenhua675@126.com   
Principal Investigator: Su Guohai, Doctor         
Sub-Investigator: Li Zhenhua, Doctor         
Sponsors and Collaborators
Jinan Central Hospital
Investigators
Principal Investigator: Su Guohai, Doctor Jinan Central Hospital
  More Information

No publications provided

Responsible Party: Su Guohai, Chief Physician, Jinan Central Hospital
ClinicalTrials.gov Identifier: NCT02123004     History of Changes
Other Study ID Numbers: ISSBRIL0249, Brilinta-0249
Study First Received: April 20, 2014
Last Updated: April 23, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Jinan Central Hospital:
ST-Segment Elevation Myocardial Infarction
Percutaneous Coronary Intervention

Additional relevant MeSH terms:
Myocardial Infarction
Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis
Ticagrelor
Clopidogrel
Ticlopidine
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on October 19, 2014