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

NCT02639143 | Completed Phase 4 DMC

• 1 other identifier: ESR-14-10167
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Inflammation; Thrombosis

Outcome Measures

Primary Outcomes (1)

• Number of total inflammatory cells per mm2 thrombus area.

  To evaluate the efficacy of ticagrelor compared to clopidogrel for the attenuation of inflammatory cell infiltration in thrombus aspirated from STEMI patients.

  Thrombus will be got from aspiration in culprit lesions during primary PCI.It will be fixed immediately and tested in 48 hours.

Secondary Outcomes (7)

• Intracoronary thrombus size

  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

  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

  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

  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

  after randomization and before loading dose P2Y12 receptor inhibitor,5-7 days after PCI,1 month ± 5 days.

Study Arms (2)

ticagrelor

EXPERIMENTAL

Ticagrelor, 180 mg, oral administration. followed by 90 mg bid

Drug: ticagrelor

Clopidogrel

ACTIVE COMPARATOR

Clopidogrel 600 mg loading dose taken orally, followed by 75 mg qd.

Drug: Clopidogrel

Interventions

ticagrelor DRUG

ticagrelor

Clopidogrel DRUG

Clopidogrel

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead

MeSH Terms

Conditions

Inflammation; Thrombosis

Interventions

Ticagrelor; Clopidogrel

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: December 24, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 23, 2021

Record last verified: 2015-11