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

Caen University Hospital

Status and phase: Completed; Phase 4

Conditions: ST-elevation Myocardial Infarction

Treatments: Procedure: standard PCI; Drug: cangrelor perfusion during PCI

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04927949

20-126

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 3 patient groups, including a placebo group

patients without HPR

Sham Comparator group

Description:

standard primary PCI

Treatment:

Procedure: standard PCI

patients with HPR randomized to cangrelor

Experimental group

Description:

Cangrelor perfusion started before PCI

Treatment:

Drug: cangrelor perfusion during PCI

patients with HPR randomized to standard of care

Placebo Comparator group

Description:

standard primary PCI

Treatment:

Procedure: standard PCI