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Mechanism Of Stent Thrombosis (MOST) Study (Most)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01410539
First Posted: August 5, 2011
Last Update Posted: September 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
David Antoniucci, Careggi Hospital
  Purpose
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.

Condition Intervention Phase
Coronary Artery Stent Thrombosis Platelet Thrombus Device: OCT guided PCI Drug: OCT guided medical therapy Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mechanism Of Stent Thrombosis (MOST) Study, a Prospective Multicentre Non-randomized Registry

Resource links provided by NLM:


Further study details as provided by David Antoniucci, Careggi Hospital:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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.


Enrollment: 20
Study Start Date: January 2010
Study Completion Date: October 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stent Thrombosis
Consecutive patients with stent thrombosis with stent strut assessment by OCT
Device: OCT guided PCI
OCT guided PCI. Only thrombectomy in case of negative OCT findings (other than uncovered struts).
Active Comparator: Controls
Control subjects without stent thrombosis from the RHR OCT database
Drug: OCT guided medical therapy
OCT guided medical therapy. Tailored antiplatelet therapy.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01410539


Locations
Italy
Careggi Hospital, Department of Hearth and Vessels
Florence, Italy
Sponsors and Collaborators
Careggi Hospital
Investigators
Study Chair: David Antoniucci, MD Careggi Hospital, Division of Invasive Cardiology
Principal Investigator: Francesco Prati, MD Rome Heart Research
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Antoniucci, Head Division of Invasive Cardiology, Careggi Hospital
ClinicalTrials.gov Identifier: NCT01410539     History of Changes
Other Study ID Numbers: MOST Study
First Submitted: August 4, 2011
First Posted: August 5, 2011
Last Update Posted: September 25, 2014
Last Verified: September 2014

Keywords provided by David Antoniucci, Careggi Hospital:
Stent Thrombosis
Percutaneous Coronary Intervention
Bare Metal Stent
Drug Eluting Stent
Residual Platelet Reactivity
Optical Coherence Tomography
OCT

Additional relevant MeSH terms:
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases