NCT02123004

Brief Summary

  1. 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. 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 25, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

February 25, 2015

Status Verified

February 1, 2015

Enrollment Period

2.1 years

First QC Date

April 20, 2014

Last Update Submit

February 24, 2015

Conditions

ST-Segment Elevation Myocardial Infarction

Keywords

ST-Segment Elevation Myocardial InfarctionPercutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (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).

    0 -4 weeks

Secondary Outcomes (3)

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

    24hour after dosing

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

    1 weeks after Percutaneous Coronary Intervention

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

    1 hour after dosing

Other Outcomes (1)

  • Adverse Event

    during 4 weeks follow up

Study Arms (2)

Ticagrelor

EXPERIMENTAL

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

Clopidogrel

ACTIVE COMPARATOR

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

Interventions

TicagrelorDRUG

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

Also known as: Brilinta
Ticagrelor
ClopidogrelDRUG

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

Also known as: plavix
Clopidogrel

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinan Central Hospital

Jinan, Shandong, 250013, China

Location

Related Publications (2)

  • 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.

    PMID: 37203392DERIVED

  • 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.

    PMID: 26865043DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

TicagrelorClopidogrel

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

AdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesTiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Su Guohai, Doctor

    Jinan Central Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Su Guohai, Doctor

CONTACT

+86(0)13370582008guohaisu@medmail.com.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

April 20, 2014

First Posted

April 25, 2014

Study Start

April 1, 2014

Primary Completion

May 1, 2016

Study Completion

August 1, 2016

Last Updated

February 25, 2015

Record last verified: 2015-02

Locations

CN(1)