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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02123004
Other study ID # ISSBRIL0249
Secondary ID Brilinta-0249
Status Not yet recruiting
Phase Phase 4
First received April 20, 2014
Last updated February 24, 2015
Start date April 2014
Est. completion date August 2016

Study information

Verified date February 2015
Source Jinan Central Hospital
Contact Su Guohai, Doctor
Phone +86(0)13370582008
Email guohaisu@medmail.com.cn
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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).


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 350
Est. completion date August 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Ticagrelor
180mg loading dose for one day ,and then 90mg per day for 4 weeks
Clopidogrel
300mg loading dose for one day ,and then 75mg per day for 4 weeks

Locations

Country Name City State
China Jinan Central Hospital Jinan Shi Shandong

Sponsors (1)

Lead Sponsor Collaborator
Jinan Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Adverse Event 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. during 4 weeks follow up Yes
Primary CD40 Ligand(CD40l)/C-reactive protein(CRP)/P-selectin and Circulating Endothelial Cells(CECs) 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). 0 -4 weeks No
Secondary CD40 Ligand(CD40l)/C-reactive protein(CRP)/P-selectin and Circulating Endothelial Cells(CECs) 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); 24hour after dosing No
Secondary CD40 Ligand(CD40l)/C-reactive protein(CRP)/P-selectin and Circulating Endothelial Cells(CECs) 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); 1 weeks after Percutaneous Coronary Intervention No
Secondary CD40 Ligand(CD40l)/C-reactive protein(CRP)/P-selectin and Circulating Endothelial Cells(CECs) the coronary serum level of CD40 Ligand(CD40l)/C-reactive protein(CRP)/P-selectin and Circulating Endothelial Cells(CECs),1 hour after dosing; 1 hour after dosing No
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