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Rapid P2Y12 Receptor Inhibition Attenuates Inflammatory Cell Infiltration in Thrombus Aspirated From the STEMI Patients

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ClinicalTrials.gov Identifier: NCT02639143
Recruitment Status : Unknown
Verified November 2015 by First Affiliated Hospital of Harbin Medical University.
Recruitment status was:  Not yet recruiting
First Posted : December 24, 2015
Last Update Posted : December 24, 2015
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital of Harbin Medical University

Tracking Information
First Submitted Date  ICMJE November 23, 2015
First Posted Date  ICMJE December 24, 2015
Last Update Posted Date December 24, 2015
Study Start Date  ICMJE December 2015
Estimated Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2015)
Number of total inflammatory cells per mm2 thrombus area. [ Time Frame: Thrombus will be got from aspiration in culprit lesions during primary PCI.It will be fixed immediately and tested in 48 hours. ]
To evaluate the efficacy of ticagrelor compared to clopidogrel for the attenuation of inflammatory cell infiltration in thrombus aspirated from STEMI patients.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2015)
  • Intracoronary thrombus size [ Time Frame: Thrombus will be got from aspiration in culprit lesions during primary PCI.It will be fixed immediately and tested in 48 hours. ]
  • Number of neutrophils per mm2 thrombus area [ Time Frame: Thrombus will be got from aspiration in culprit lesions during primary PCI.It will be fixed immediately and tested in 48 hours. ]
  • Number of macrophages per mm2 thrombus area [ Time Frame: Thrombus will be got from aspiration in culprit lesions during primary PCI.It will be fixed immediately and tested in 48 hours. ]
  • Number of Myeloperoxidase-positive cells per mm2 thrombus area [ Time Frame: Thrombus will be got from aspiration in culprit lesions during primary PCI.It will be fixed immediately and tested in 48 hours. ]
  • Serum high-sensitivity C-reactive protein level [ Time Frame: after randomization and before loading dose P2Y12 receptor inhibitor,5-7 days after PCI,1 month ± 5 days. ]
    A total of three times
  • Plasma concentration of ticagrelor [ Time Frame: At 90 min, 2h, 8h, 12h and 24h after received loading dose P2Y12 receptor inhibitor. ]
  • Rate of Thrombolysis In Myocardial Infarction (TIMI) major bleeding [ Time Frame: Follow up: 1 month ± 5 days. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rapid P2Y12 Receptor Inhibition Attenuates Inflammatory Cell Infiltration in Thrombus Aspirated From the STEMI Patients
Official Title  ICMJE Rapid P2Y12 Receptor Inhibition Attenuates Inflammatory Cell Infiltration in Thrombus Aspirated From the Infarct-related Artery in STEMI Patients: A Prospective Randomized Trial of Ticagrelor Versus Clopidogrel
Brief Summary This is a prospective, randomized, parallel design study to investigate that ticagrelor could attenuate inflammatory cell infiltration in thrombus aspirated from ST elevation myocardial infarction (STEMI) patients. The anticipated duration of the study is approximately 9 months, including an anticipated enrolment period of 8 months and follow-up period of 1 month. Patients within 12 hours of symptom onset were randomly assigned in a one-to-one ratio to receive ticagrelor or clopidogrel at time of STEMI diagnosis. The primary endpoint was the extent of inflammatory cell infiltration in thrombus aspirated from STEMI patients, expressed as number of total inflammatory cells per mm2 thrombus area.
Detailed Description

This is a prospective, randomized, parallel design study to investigate that ticagrelor could attenuate inflammatory cell infiltration in thrombus aspirated from STEMI patients. The anticipated duration of the study is approximately 9 months, including an anticipated enrolment period of 8 months and follow-up period of 1 month. Patients within 12 hours of symptom onset were randomly assigned in a one-to-one ratio to receive ticagrelor or clopidogrel at time of STEMI diagnosis. The primary endpoint was the extent of inflammatory cell infiltration in thrombus aspirated from STEMI patients, expressed as number of total inflammatory cells per mm2 thrombus area.

Screening will be made to select eligible participants before intervention. Patients with documented STEMI and within 12 hours of symptom onset will be enrolled from the study site. For patients post percutaneous coronary intervention (PCI), they must be on dual-antiplatelet therapy for at least 12 months to be eligible for the study.

After the enrollment period, patients were randomly assigned in a one-to-one ratio to receive ticagrelor (180 mg loading dose) or clopidogrel (600 mg loading dose) at time of STEMI diagnosis. In addition to randomized study medication all patients should receive concomitant Ace Salicylic Acid (ASA) 100 mg daily during the treatment period according to local practice, unless they are allergic or intolerant. For those not previously given aspirin, a loading dose of 300 mg was preferred. At the end of the study, data will be collected and analyzed.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Inflammation
  • Thrombosis
Intervention  ICMJE
  • Drug: ticagrelor
  • Drug: Clopidogrel
Study Arms  ICMJE
  • Experimental: ticagrelor
    Ticagrelor, 180 mg, oral administration. followed by 90 mg bid
    Intervention: Drug: ticagrelor
  • Active Comparator: Clopidogrel
    Clopidogrel 600 mg loading dose taken orally, followed by 75 mg qd.
    Intervention: Drug: Clopidogrel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 20, 2015)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2017
Estimated Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Provision of informed consent prior to any study specific procedures
  • Males and non-pregnant females > 18 and < 79 years of age.
  • Symptoms consistent with STEMI lasting > 30 min.
  • Arrival at the hospital within 12 h of the onset of chest pain.
  • Intention to perform PCI

Exclusion Criteria:

  • On treatment with a P2Y12 receptor antagonist (ticlopidine, clopidogrel, prasugrel, ticagrelor) in past 30 days.
  • Known allergies to aspirin or ticagrelor or clopidogrel.
  • On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban).
  • Treatment with IIb/IIIa glycoprotein inhibitors in the last 7 days.
  • Known pregnancy, breast-feeding, or intend to become pregnant during the study period.
  • Active pathological bleeding
  • History of prior intracranial bleeding.
  • Renal dysfunction (serum creatinine levels ≥ 2.0 mg/dL).
  • Severe, non-catheter-related coronary artery spasm.
  • New York Heart Association (NYHA) class III or IV heart failure or known left ventricular ejection fraction < 30%.
  • Known severe hepatic dysfunction.
  • Hemodynamic or electrical instability (including shock).
  • Concomitant inflammatory diseases, malignant tumours, anaemia or thrombocytopenia.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02639143
Other Study ID Numbers  ICMJE ESR-14-10167
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party First Affiliated Hospital of Harbin Medical University
Study Sponsor  ICMJE First Affiliated Hospital of Harbin Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account First Affiliated Hospital of Harbin Medical University
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP