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

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

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.

Study Overview

• Status: Completed
• Conditions: ST-elevation Myocardial Infarction
• Intervention / Treatment: Procedure: standard PCI; Drug: cangrelor perfusion during PCI

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Caen, France, 14000
    • CAEN University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: patients without HPR; standard primary PCI	Procedure: standard PCI; primary PCI without cangrelor
Experimental: patients with HPR randomized to cangrelor; Cangrelor perfusion started before PCI	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
Placebo Comparator: patients with HPR randomized to standard of care; standard primary PCI	Procedure: standard PCI; primary PCI without cangrelor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grade of myocardial blush	myocardial blush grade from 0 to 3 (normal)	during procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of residual thrombus burden	intrastent residual thrombus burden assessed by optical coherence tomography	during procedure
measure of platelet reactivity	Platelet reactivity using VerifyNow after PCI for patients with basal platelet reaction unit>208	during procedure
troponin	peak value	day 1
infarct size and no reflow on MRI		during hospitalization assessed up to 7 days
clinical outcomes	death, new myocardial infarction, stent thrombosis, new revascularization, stroke, major bleeding	during hospitalization assessed up to 7 days

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Collaborators: Terumo Medical Corporation

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2021
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: May 27, 2021
• First Submitted That Met QC Criteria: June 9, 2021
• First Posted (Actual): June 16, 2021

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Cangrelor
• Other Study ID Numbers: 20-126

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No