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

Inflammation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02639143
• Other study ID #: ESR-14-10167
• Status: Completed
• Phase: Phase 4
• Start date: December 2015
• Est. completion date: December 2017

Study information

• Verified date: November 2015
• Source: First Affiliated Hospital of Harbin Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation
• Thrombosis

Intervention

Drug:
• ticagrelor

• Clopidogrel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Harbin Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Serum high-sensitivity C-reactive protein level	A total of three times	after randomization and before loading dose P2Y12 receptor inhibitor,5-7 days after PCI,1 month ± 5 days.
Secondary	Plasma concentration of ticagrelor		At 90 min, 2h, 8h, 12h and 24h after received loading dose P2Y12 receptor inhibitor.
Secondary	Rate of Thrombolysis In Myocardial Infarction (TIMI) major bleeding		Follow up: 1 month ± 5 days.