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Comparison of Ticagrelor And Clopidogrel on Inflammatory Biomarkers And Vascular Endothelial Function (TIGERCAVE)

Primary Purpose

ST-Segment Elevation Myocardial Infarction

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Ticagrelor

Clopidogrel

About this trial

This is an interventional treatment trial for ST-Segment Elevation Myocardial Infarction focused on measuring ST-Segment Elevation Myocardial Infarction, Percutaneous Coronary Intervention

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or non-pregnant female.
Age ≥ 18 years old and <80 years old.
Consecutive patients who should be hospitalized with documented evidence of ST-Segment Elevation Myocardial Infarction receiving Percutaneous Coronary Intervention.
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.
Time from chest pain onset to receiving Percutaneous Coronary Intervention <12 hours.
Persistent chest pain <12 hours.
Provision of informed consent prior to any study specific procedures.

Exclusion Criteria:

Involved in other trials.
In recent one year have P 2 Y 12 receptor antagonist drug treatment history or long-term use of immunosuppressive agents.
Recurrent myocardial infarction or previous history of Coronary Artery Bypass Graft(CABG) surgery or rescue Percutaneous Coronary Intervention.
Active bleeding or bleeding history.
With obvious infection and body temperature (axillary temperature) higher than 38.0 ℃.
Autoimmune diseases.
Malignancies.
In recent 6 months have received major surgery.
Left ventricular ejection fraction is less than 30%.
Life expectancy less than one year.
With moderate and severe liver function deterioration.
End-stage renal failure.
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.
Other contraindications to investigate products.
Any condition that increases the risk for noncompliance or being lost to follow-up.

Sites / Locations

Jinan Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ticagrelor

Clopidogrel

Arm Description

Investigational product/Dosage form and strength/Manufacturer: ticagrelor/tablet /90mg/AstraZeneca 180mg loading dose for one day ,then 90mg per day for 4 weeks

Investigational product/Dosage form and strength/Manufacturer: clopidogrel/tablet /75mg/Sanofi 300mg loading dose for one day ,then 75mg per day for 4 weeks

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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);

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);

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;

Full Information

NCT ID

NCT02123004

First Posted

April 20, 2014

Last Updated

February 24, 2015

Sponsor

Jinan Central Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02123004

Brief Title

Comparison of Ticagrelor And Clopidogrel on Inflammatory Biomarkers And Vascular Endothelial Function

Acronym

TIGERCAVE

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Unknown status

Study Start Date

April 2014 (undefined)

Primary Completion Date

May 2016 (Anticipated)

Study Completion Date

August 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Jinan Central Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ST-Segment Elevation Myocardial Infarction

Keywords

ST-Segment Elevation Myocardial Infarction, Percutaneous Coronary Intervention

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ticagrelor

Arm Type

Experimental

Arm Description

Investigational product/Dosage form and strength/Manufacturer: ticagrelor/tablet /90mg/AstraZeneca 180mg loading dose for one day ,then 90mg per day for 4 weeks

Arm Title

Clopidogrel

Arm Type

Active Comparator

Arm Description

Investigational product/Dosage form and strength/Manufacturer: clopidogrel/tablet /75mg/Sanofi 300mg loading dose for one day ,then 75mg per day for 4 weeks

Intervention Type

Drug

Intervention Name(s)

Ticagrelor

Other Intervention Name(s)

Brilinta

Intervention Description

180mg loading dose for one day ,and then 90mg per day for 4 weeks

Intervention Type

Drug

Intervention Name(s)

Clopidogrel

Other Intervention Name(s)

plavix

Intervention Description

300mg loading dose for one day ,and then 75mg per day for 4 weeks

Primary Outcome Measure Information:

Title

CD40 Ligand(CD40l)/C-reactive protein(CRP)/P-selectin and Circulating Endothelial Cells(CECs)

Description

Time Frame

0 -4 weeks

Secondary Outcome Measure Information:

Title

CD40 Ligand(CD40l)/C-reactive protein(CRP)/P-selectin and Circulating Endothelial Cells(CECs)

Description

Time Frame

24hour after dosing

Title

CD40 Ligand(CD40l)/C-reactive protein(CRP)/P-selectin and Circulating Endothelial Cells(CECs)

Description

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);

Time Frame

1 weeks after Percutaneous Coronary Intervention

Title

CD40 Ligand(CD40l)/C-reactive protein(CRP)/P-selectin and Circulating Endothelial Cells(CECs)

Description

the coronary serum level of CD40 Ligand(CD40l)/C-reactive protein(CRP)/P-selectin and Circulating Endothelial Cells(CECs),1 hour after dosing;

Time Frame

1 hour after dosing

Other Pre-specified Outcome Measures:

Title

Adverse Event

Description

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.

Time Frame

during 4 weeks follow up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or non-pregnant female. Age ≥ 18 years old and <80 years old. Consecutive patients who should be hospitalized with documented evidence of ST-Segment Elevation Myocardial Infarction receiving Percutaneous Coronary Intervention. 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. Time from chest pain onset to receiving Percutaneous Coronary Intervention <12 hours. Persistent chest pain <12 hours. Provision of informed consent prior to any study specific procedures. Exclusion Criteria: Involved in other trials. In recent one year have P 2 Y 12 receptor antagonist drug treatment history or long-term use of immunosuppressive agents. Recurrent myocardial infarction or previous history of Coronary Artery Bypass Graft(CABG) surgery or rescue Percutaneous Coronary Intervention. Active bleeding or bleeding history. With obvious infection and body temperature (axillary temperature) higher than 38.0 ℃. Autoimmune diseases. Malignancies. In recent 6 months have received major surgery. Left ventricular ejection fraction is less than 30%. Life expectancy less than one year. With moderate and severe liver function deterioration. End-stage renal failure. 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. Other contraindications to investigate products. Any condition that increases the risk for noncompliance or being lost to follow-up.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Su Guohai, Doctor

Phone

+86(0)13370582008

guohaisu@medmail.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Su Guohai, Doctor

Organizational Affiliation

Jinan Central Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jinan Central Hospital

City

Jinan Shi

State/Province

Shandong

ZIP/Postal Code

250013

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Su Guohai, Doctor

Phone

+86(0)13370582008

guohaisu@medmail.com.cn

First Name & Middle Initial & Last Name & Degree

Li Zhenhua, Doctor

Phone

+86(0)13969081430

lizhenhua675@126.com

First Name & Middle Initial & Last Name & Degree

Su Guohai, Doctor

First Name & Middle Initial & Last Name & Degree

Li Zhenhua, Doctor

12. IPD Sharing Statement

Citations:

PubMed Identifier

26865043

Citation

Li Z, Li Y, Zhang T, Miao W, Su G. 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: study protocol for a randomized controlled trial. Trials. 2016 Feb 11;17:75. doi: 10.1186/s13063-016-1168-9.

Results Reference

derived

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Comparison of Ticagrelor And Clopidogrel on Inflammatory Biomarkers And Vascular Endothelial Function

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