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

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital of Harbin Medical University
• Treatments: Clopidogrel; Ticagrelor; Ticlopidine

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.