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

Sponsor

University Hospital, Caen (Other)

Overall Status

Recruiting

CT.gov ID

NCT04927949

Collaborator

Terumo Medical Corporation (Industry)

120

Enrollment

Location

Arms

18.8

Anticipated Duration (Months)

6.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
ST-elevation Myocardial Infarction	Drug: cangrelor perfusion during PCI Procedure: standard PCI	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 8, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Grade of myocardial blush [during procedure]
myocardial blush grade from 0 to 3 (normal)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CAEN University Hospital	Caen		France	14000

Sponsors and Collaborators

University Hospital, Caen
Terumo Medical Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Caen

ClinicalTrials.gov Identifier:

NCT04927949

Other Study ID Numbers:

20-126

First Posted:

Jun 16, 2021

Last Update Posted:

Jun 28, 2021

Last Verified:

Jun 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Myocardial Infarction

ST Elevation Myocardial Infarction

Infarction

Cangrelor

Study Results

No Results Posted as of Jun 28, 2021