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Mechanism Of Stent Thrombosis (MOST) Study (Most)

This study is currently recruiting participants.
Verified July 2011 by Careggi Hospital
Sponsor:
Information provided by:
Careggi Hospital
ClinicalTrials.gov Identifier:
NCT01410539
First received: August 4, 2011
Last updated: August 10, 2011
Last verified: July 2011
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mechanism Of Stent Thrombosis (MOST) Study, a Prospective Multicentre Non-randomized Registry

Further study details as provided by Careggi Hospital:

Primary Outcome Measures:
  • Percentage of uncovered stent struts [ Time Frame: After thrombectomy ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 20
Study Start Date: January 2010
Estimated Study Completion Date: October 2011
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01410539

Contacts
Contact: Guido Parodi, MD +390557947732 parodiguido@gmail.com

Locations
Italy
Careggi Hospital, Department of Hearth and Vessels Recruiting
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

No publications provided

Responsible Party: David Antoniucci, director of Invasive Cardiology Division, Careggi Hospital
ClinicalTrials.gov Identifier: NCT01410539     History of Changes
Other Study ID Numbers: MOST Study
Study First Received: August 4, 2011
Last Updated: August 10, 2011
Health Authority: Italy: Ministry of Health

Keywords provided by 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

ClinicalTrials.gov processed this record on May 16, 2013