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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Inflammation Thrombosis Drug: ticagrelor Drug: Clopidogrel Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2015
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

Arms and Interventions
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Arm Intervention/treatment
Experimental: ticagrelor
Ticagrelor, 180 mg, oral administration. followed by 90 mg bid
 Drug: ticagrelor
Active Comparator: Clopidogrel
Clopidogrel 600 mg loading dose taken orally, followed by 75 mg qd.
 Drug: Clopidogrel


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. ]
  2. 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. ]
  3. 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. ]
  4. 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. ]
  5. 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

  6. Plasma concentration of ticagrelor [ Time Frame: At 90 min, 2h, 8h, 12h and 24h after received loading dose P2Y12 receptor inhibitor. ]
  7. Rate of Thrombolysis In Myocardial Infarction (TIMI) major bleeding [ Time Frame: Follow up: 1 month ± 5 days. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639143


Contacts
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Contact: Ye Tian, MD, PhD +86 451 85555943 yetian6@163.com

Sponsors and Collaborators
First Affiliated Hospital of Harbin Medical University
More Information
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Responsible Party: First Affiliated Hospital of Harbin Medical University
ClinicalTrials.gov Identifier: NCT02639143    
Other Study ID Numbers: ESR-14-10167
First Posted: December 24, 2015    Key Record Dates
Last Update Posted: December 24, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Thrombosis
Inflammation
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Clopidogrel
Ticagrelor
 Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs