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Completed

NCT Number: NCT01410539

Mechanism Of Stent Thrombosis (MOST) Study

This study is designed to assess the pathophysiology of ST by studying the main procedural and anatomical factors involved in the genesis of ST such as those related to stent and the vascular wall, as well as to the individual platelet residual reactivity.

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Key information

Conditions

Coronary Artery Cardiovascular Diseases Embolism and Thrombosis Platelet Stent Thrombosis Thrombosis Thrombus Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Careggi Hospital, Department of Hearth and Vessels

Florence, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • previous PCI with bare metal stent (BMS) or drug eluting stent (DES) and a definite subacute coronary ST
  • previous PCI with DES and a definite late or very late coronary ST

Exclusion criteria

  • Development of ST within 72 hours of stent implantation (acute and early subacute ST).
  • Late and very late ST of BMS.
  • Absence of informed consent.
  • Age less than 18 years.
  • Creatinine values greater than 2.5 g/dl (this is to avoid the negative effects related to the contrast medium necessary to perform the OCT evaluation).

Treatment and study plan

OCT guided PCI

Device

OCT guided PCI. Only thrombectomy in case of negative OCT findings (other than uncovered struts).

OCT guided medical therapy

Drug

OCT guided medical therapy. Tailored antiplatelet therapy.

Primary outcomes

  1. Percentage of uncovered stent struts

    Time frame: After thrombectomy

    The percentage of uncovered stent struts by OCT in patients with subacute stent thrombosis (either DES and BMS) and the percentage of uncovered stent struts in patients with late (after one month) and very late thrombosis of DES.

Secondary outcomes

  1. Percentage of malapposed stent struts

    Time frame: After Thrombectomy

    The percentage of malapposed stent struts by OCT in patients with subacute thrombosis of DES and BMS and the percentage of malapposed stent struts by OCT in patients with late and very late thrombosis of DES.

  2. Percentage of patients with high residual platelet reactivity

    Time frame: Baseline

    The percentage of patients with residual platelet reactivity (RPR) to ADP and arachidonic acid identified by values ≥ 240 P2Y12 reaction units (PRU) and ≥ 550 aspirin reaction units (ARU), respectively,. during aspirin and clopidogrel therapy or in which one or both the antiplatelet drugs have been interrupted.

Sponsors and collaborators

Lead sponsor

Careggi Hospital

Other

Registry information

Official study title

Mechanism Of Stent Thrombosis (MOST) Study, a Prospective Multicentre Non-randomized Registry

Acronym: Most

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 5, 2011
Registry last updated
Sep 25, 2014

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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