AzTrials
AzTrials

ST-Segment Elevation Myocardial InfarctionPhase 4TIGERCAVENCT02123004

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

A Phase 4 study testing Ticagrelor and Clopidogrel in people with ST-Segment Elevation Myocardial Infarction, run by Jinan Central Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Ticagrelor and Clopidogrel
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
1 siteChina
Study dates
Apr 2014to Aug 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Su Guohai, Doctor contact

+86(0)13370582008

guohaisu@medmail.com.cn

China1 site

  • Jinan Central Hospital

    Jinan, Shandong, 250013

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

    Li Zhenhua, Doctor, +86(0)13969081430, lizhenhua675@126.com

Other trials in China

About this study

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

  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).
Read the 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.

Being tested
Ticagrelor, Clopidogrel
Keywords
ST-Segment Elevation Myocardial Infarction, Percutaneous Coronary Intervention
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TicagrelorDrug

    Also called Brilinta

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

  • ClopidogrelDrug

    Also called plavix

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

Study groups in NCT02123004
Study groupRoleWhat they receive
TicagrelorExperimentalInvestigational product/Dosage form and strength/Manufacturer: ticagrelor/tablet /90mg/AstraZeneca 180mg loading dose for one day ,then 90mg per day for 4 weeks
Receives: Drug: Ticagrelor
ClopidogrelActive comparatorInvestigational product/Dosage form and strength/Manufacturer: clopidogrel/tablet /75mg/Sanofi 300mg loading dose for one day ,then 75mg per day for 4 weeks
Receives: Drug: Clopidogrel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 0 -4 weeks

Secondary outcomes (3)

  1. 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);

    Measured: 24hour after dosing

  2. 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);

    Measured: 1 weeks after Percutaneous Coronary Intervention

  3. 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;

    Measured: 1 hour after dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionMay 2016 (estimated)
  4. Study completionAug 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02123004
Sponsor's protocol ID
ISSBRIL0249
Other IDs
Brilinta-0249
Acronym
TIGERCAVE
Status last verified
Feb 2015
First submitted
20 Apr 2014
Last updated
25 Feb 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Liu P, Wang S, Li K, Yang Y, Man Y, Du F, Wang L, Tian J, Su G. Exosomal microRNA-4516, microRNA-203 and SFRP1 are potential biomarkers of acute myocardial infarction. Mol Med Rep. 2023 Jun;27(6):124. doi: 10.3892/mmr.2023.13010. Epub 2023 May 19.

    PubMed 37203392

  • 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.

    PubMed 26865043

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ticagrelor and Clopidogrel in people with ST-Segment Elevation Myocardial Infarction, run by Jinan Central Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Su Guohai, Doctor (+86(0)13370582008, guohaisu@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CD40 Ligand(CD40l)/C-reactive protein(CRP)/P-selectin and Circulating Endothelial Cells(CECs) (time frame: 0 -4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02123004, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in