ST-elevation Myocardial InfarctionPhase 4ERMITNCT04927949
Evaluation of Myocardial Reperfusion After Primary PCI in Patients With High Platelet Reactivity Treated by Cangrelor or Not
A Phase 4 study testing cangrelor perfusion during PCI and standard PCI in people with ST-elevation Myocardial Infarction, run by University Hospital, Caen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST-elevation Myocardial Infarction
- What is being tested?
- cangrelor perfusion during PCI and standard PCI
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jun 2021to 31 Mar 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 9Show fewer
- history of stroke (ischemic or hemorrhagic) or transient ischemic attack
- known severe renal insufficiency (eGFR <30 ml/min)
- oral anticoagulation
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- ST-elevation Myocardial Infarction
- Being tested
- cangrelor perfusion during PCI, standard PCI
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cangrelor perfusion during PCIDrug
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
standard PCIProcedure or surgery
primary PCI without cangrelor
| Study group | Role | What they receive |
|---|---|---|
| patients without HPR | Sham comparator | standard primary PCI Receives: Procedure: standard PCI |
| patients with HPR randomized to cangrelor | Experimental | Cangrelor perfusion started before PCI Receives: Drug: cangrelor perfusion during PCI |
| patients with HPR randomized to standard of care | Placebo comparator | standard primary PCI Receives: Procedure: standard PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade of myocardial blush
myocardial blush grade from 0 to 3 (normal)
Measured: during procedure
Secondary outcomes (5)
percentage of residual thrombus burden
intrastent residual thrombus burden assessed by optical coherence tomography
Measured: during procedure
measure of platelet reactivity
Platelet reactivity using VerifyNow after PCI for patients with basal platelet reaction unit>208
Measured: during procedure
troponin
peak value
Measured: day 1
infarct size and no reflow on MRI
Measured: during hospitalization assessed up to 7 days
clinical outcomes
death, new myocardial infarction, stent thrombosis, new revascularization, stroke, major bleeding
Measured: during hospitalization assessed up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start8 Jun 2021
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ST-elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- Terumo Medical Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04927949
- Sponsor's protocol ID
- 20-126
- Acronym
- ERMIT
- Status last verified
- Jan 2023
- First submitted
- 27 May 2021
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
V Roule, R Stettler, K Blanchart, M Bignon, A Lemaitre, C Peron, P Guedeney, M Zeitouni, L Schwob, R Sabatier, G Montalescot, J J Parienti, F Beygui, Cangrelor use in ticagrelor-loaded ST-elevation myocardial infarction patients with high residual platelet reactivity: a randomized controlled trial, European Heart Journal, Volume 45, Issue Supplement_1, October 2024, ehae666.1637, https://doi.org/10.1093/eurheartj/ehae666.1637
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04927949
- Acronym / sponsor ID
- ERMIT / 20-126
- Conditions
- ST-elevation Myocardial Infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Terumo Medical Corporation
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 16 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients without HPR | Sham comparator | Procedure: standard PCIstandard primary PCI |
| patients with HPR randomized to cangrelor | Experimental | Drug: cangrelor perfusion during PCICangrelor perfusion started before PCI |
| patients with HPR randomized to standard of care | Placebo comparator | Procedure: standard PCIstandard primary PCI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cangrelor perfusion during PCICangrelor 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 | Drug | patients with HPR randomized to cangrelor |
| standard PCIprimary PCI without cangrelor | Procedure or surgery | patients with HPR randomized to standard of care, patients without HPR |
Primary outcome
Grade of myocardial blush
Time frame: during procedure
myocardial blush grade from 0 to 3 (normal)
5 secondary outcomes
percentage of residual thrombus burden
Time frame: during procedure
measure of platelet reactivity
Time frame: during procedure
troponin
Time frame: day 1
infarct size and no reflow on MRI
Time frame: during hospitalization assessed up to 7 days
clinical outcomes
Time frame: during hospitalization assessed up to 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Results publicationV Roule, R Stettler, K Blanchart, M Bignon, A Lemaitre, C Peron, P Guedeney, M Zeitouni, L Schwob, R Sabatier, G Montalescot, J J Parienti, F Beygui, Cangrelor use in ticagrelor-loaded ST-elevation myocardial infarction patients with high residual platelet reactivity: a randomized controlled trial, European Heart Journal, Volume 45, Issue Supplement_1, October 2024, ehae666.1637, https://doi.org/10.1093/eurheartj/ehae666.1637
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cangrelor perfusion during PCI and standard PCI in people with ST-elevation Myocardial Infarction, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade of myocardial blush (time frame: during procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04927949, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.