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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03342521
Other study ID # 17-107
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 13, 2017
Est. completion date December 31, 2018

Study information

Verified date November 2017
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The management of ST-elevation myocardial infarction in the acute phase requires an optimal antiaggregation combining aspirin and a P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor). Primary percutaneous coronary intervention must be performed within 2 hours of first medical contact. However, even with the new P2Y12 inhibitors, effective platelet inhibition which is required to inhibit the progression of intracoronary thrombus, is present only in half of the patients at 2 hours.

Optical coherence tomography (OCT) is the reference method for visualizing and quantifying intracoronary thrombus. The post-stenting intracoronary residual mass evaluated in OCT was associated with altered myocardial reperfusion indices, which were themselves associated with the prognosis of the patient. However, the determinants of this post-stenting residual mass -mostly thrombotic- remain unknown.

Measurement of platelet reactivity (expressed as P2Y12 Reaction Unit and Aspirin Reaction Unit) by simple turbidimetric tests (VerifyNow) is available in the cathlab. Enhanced platelet reactivity is reported in patients with acute coronary syndrome and represents a high-risk situation for recurrent coronary events in this setting.

The study aims to:

1. to evaluate the relationship between the post-stenting residual intracoronary mass evaluated in OCT and the platelet response at the time of the PCI evaluated by Verify Now

2. to confirm the impact of the residual mass measured by OCT on the EKG and angiographic myocardial reperfusion indices

3. identify patients with high thrombotic risk who may require more intensive antithrombotic therapy

4. identify simple biological markers associated with the residual mass measured by OCT


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- primary PCI with successful stenting for ST-elevation myocardial infarction

- pretreated with ticagrelor, aspirin and enoxaparin

- OCT and verifyNow performed in the acute phase

Exclusion Criteria:

- stent thrombosis

- known coagulation disorder

- clinical instability

- pregnancy

Study Design


Intervention

Diagnostic Test:
optical coherence tomography and VerifyNow
optical coherence tomography Imaging P2Y12 and Aspirin reaction units quantification by the VerifyNow

Locations

Country Name City State
France CAEN University Hospital Caen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary the volume of residual intrastent mass measured by OCT volume of the residual mass in mm3 day 0
Primary the platelet reactivity assessed by VerifyNow P2Y12 and aspirin reaction units, assessed by VerifyNow day 0
Secondary regression of EKG ST-segment elevation regression of ST-segment elevation >50% after angioplasty day 0
Secondary Corrected Timi Frame count TIMI frame count (number) assessed after angioplasty day 0
Secondary Myocardial blush grade Blush grade (from 0= no blush; 1=minimal; 2=moderate to 3= normal blush) assessed on angiography after angioplasty day 0
Secondary angiographic pre-stenting thrombus grade angiographic thrombus grade score (from 0=no thrombus to 5=occlusive thrombus) day 0
Secondary troponin biological marker (µg/L) day 0
Secondary fibrinogen biological marker (in g/L) day 0
Secondary albumin biological marker (in g/L) day 0
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