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Completed

NCT Number: NCT03342521

OFDI-Quantified Intracoronary Thrombus, Antiplatelet Pretreatment Effect and Myocardial Reperfusion

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

optical coherence tomography and VerifyNow

Diagnostic Test

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

Primary outcomes

  1. the volume of residual intrastent mass measured by OCT

    Time frame: day 0

    volume of the residual mass in mm3

  2. the platelet reactivity assessed by VerifyNow

    Time frame: day 0

    P2Y12 and aspirin reaction units, assessed by VerifyNow

Secondary outcomes

  1. regression of EKG ST-segment elevation

    Time frame: day 0

    regression of ST-segment elevation >50% after angioplasty

  2. Corrected Timi Frame count

    Time frame: day 0

    TIMI frame count (number) assessed after angioplasty

  3. Myocardial blush grade

    Time frame: day 0

    Blush grade (from 0= no blush; 1=minimal; 2=moderate to 3= normal blush) assessed on angiography after angioplasty

  4. angiographic pre-stenting thrombus grade

    Time frame: day 0

    angiographic thrombus grade score (from 0=no thrombus to 5=occlusive thrombus)

  5. troponin

    Time frame: day 0

    biological marker (µg/L)

  6. fibrinogen

    Time frame: day 0

    biological marker (in g/L)

  7. albumin

    Time frame: day 0

    biological marker (in g/L)

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

Optical Frequency Domain Imaging-Quantified Intracoronary Thrombus Mass During Primary Percutaneous Coronary Intervention, Its Relationship With Antiplatelet Pretreatment Effect And Its Impact On Myocardial Reperfusion

Acronym: ODIPP

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 17, 2017
Registry last updated
Apr 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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