Evaluation of Myocardial Reperfusion After Primary PCI in Patients With High Platelet Reactivity Treated by Cangrelor or Not

ST-elevation Myocardial Infarction Clinical Trial

— ERMIT  

Official title:

Evaluation of Myocardial Reperfusion and Residual Thrombotic Burden After Primary PCI for STEMI in Patients With High on Ticagrelor Platelet Reactivity Treated by IV Cangrelor Versus Ticagrelor Alone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04927949
• Other study ID #: 20-126
• Status: Completed
• Phase: Phase 4
• Start date: June 8, 2021
• Est. completion date: March 31, 2023

Study information

• Verified date: January 2023
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate the impact on myocardial reperfusion and residual thrombotic burden of adding Cangrelor -a potent and immediate P2Y12 inhibitor- to ticagrelor in primary PCI patients with high on ticagrelor platelet reactivity compared to standard of care with ticagrelor alone.

Description:

Despite the use of potent P2Y12 inhibitor such as ticagrelor, half of the patients presented high platelet reactivity (HPR) at the time of primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI). HPR has been associated with impaired myocardial reperfusion. Myocardial reperfusion, assessed using myocardial blush grade, is a strong prognostic factor associated with infarct size and mortality. Antiplatelet therapy intensification using a potent and immediate P2Y12 inhibitor such as Cangrelor according a point-of-care platelet function test has not been studied in the acute phase of STEMI.

This study aims to evaluate the impact on myocardial reperfusion and residual thrombotic burden of adding Cangrelor to ticagrelor in primary PCI patients with high on ticagrelor platelet reactivity compared to standard of care with ticagrelor alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patient admitted for STEMI within 24 hours from symptom onset

• pretreated with ticagrelor, aspirin and enoxaparin (according local protocol)

• successfully treated by primary PCI of a native coronary culprit lesion

• anatomy accessible to optical coherence tomography (OCT or OFDI)

Exclusion Criteria:

• cardiogenic shock

• stent restenosis or thrombosis

• use of glycoprotein IIb/IIIa inhibitors before or during PCI

• known coagulation disease

• high bleeding risk (thrombocytopenia <100,000/dL, surgery <30 days, active bleeding)

• uncontrolled arterial hypertension (>180/110 mmHg)

• history of stroke (ischemic or hemorrhagic) or transient ischemic attack

• known severe renal insufficiency (eGFR <30 ml/min)

• oral anticoagulation

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• ST-elevation Myocardial Infarction

Intervention

Drug:
• cangrelor perfusion during PCI
Cangrelor perfusion (started before PCI) with intravenous bolus of 30 microgram/kg, followed by a perfusion of 4 microgram/kg/min during 2 hours or until the end of the PCI if longer

Procedure:
• standard PCI
primary PCI without cangrelor

Locations

Country	Name	City	State
France	CAEN University Hospital	Caen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Caen	Terumo Medical Corporation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grade of myocardial blush	myocardial blush grade from 0 to 3 (normal)	during procedure
Secondary	percentage of residual thrombus burden	intrastent residual thrombus burden assessed by optical coherence tomography	during procedure
Secondary	measure of platelet reactivity	Platelet reactivity using VerifyNow after PCI for patients with basal platelet reaction unit>208	during procedure
Secondary	troponin	peak value	day 1
Secondary	infarct size and no reflow on MRI		during hospitalization assessed up to 7 days
Secondary	clinical outcomes	death, new myocardial infarction, stent thrombosis, new revascularization, stroke, major bleeding	during hospitalization assessed up to 7 days