Mechanism Of Stent Thrombosis (MOST) Study (Most)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Careggi Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Careggi Hospital
ClinicalTrials.gov Identifier:
NCT01410539
First received: August 4, 2011
Last updated: August 10, 2011
Last verified: July 2011

August 4, 2011
August 10, 2011
January 2010
August 2011   (final data collection date for primary outcome measure)
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.
Percentage of uncovered stent struts [ Time Frame: After thrombectomy ] [ Designated as safety issue: Yes ]
The percentage of uncovered stent struts 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.
Complete list of historical versions of study NCT01410539 on ClinicalTrials.gov Archive Site
  • 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.
  • Percentage of malapposed stent struts [ Time Frame: After Thrombectomy ] [ Designated as safety issue: Yes ]
    The percentage of malapposed stent struts in patients with subacute thrombosis of DES and BMS and the percentage of malapposed stent struts in patients with late and very late thrombosis of DES.
  • Percentage of patients with an in-stent minimal luminal area [ Time Frame: After thrombectomy ] [ Designated as safety issue: Yes ]

    The percentage of patients with an in-stent minimal luminal area (MLA) < 4 mm².

    and the percentage of patients with an in-stent minimal luminal area (MLA) < 50% of the distal reference area.

  • 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.
  • Relationship between the percentage of stent struts uncoverage and residual platelet reactivity [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    The relationship between the percentage of stent struts uncoverage and residual platelet reactivity (RPR) to ADP and arachidonic acid in presence of therapy with clopidogrel and aspirin.
Not Provided
Not Provided
 
Mechanism Of Stent Thrombosis (MOST) Study
Mechanism Of Stent Thrombosis (MOST) Study, a Prospective Multicentre Non-randomized Registry

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Coronary Artery
  • Stent Thrombosis
  • Platelet
  • Thrombus
  • Device: OCT guided PCI
    OCT guided PCI. Only thrombectomy in case of negative OCT findings (other than uncovered struts).
  • Drug: OCT guided medical therapy
    OCT guided medical therapy. Tailored antiplatelet therapy.
  • Experimental: Stent Thrombosis
    Consecutive patients with stent thrombosis with stent strut assessment by OCT
    Intervention: Device: OCT guided PCI
  • Active Comparator: Controls
    Control subjects without stent thrombosis from the RHR OCT database
    Intervention: Drug: OCT guided medical therapy
Parodi G, La Manna A, Di Vito L, Valgimigli M, Fineschi M, Bellandi B, Niccoli G, Giusti B, Valenti R, Cremonesi A, Biondi-Zoccai G, Prati F. Stent-related defects in patients presenting with stent thrombosis: differences at optical coherence tomography between subacute and late/very late thrombosis in the Mechanism Of Stent Thrombosis (MOST) study. EuroIntervention. 2013 Dec;9(8):936-44. doi: 10.4244/EIJV9I8A157.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
October 2011
August 2011   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact: Guido Parodi, MD +390557947732 parodiguido@gmail.com
Italy
 
NCT01410539
MOST Study
Yes
David Antoniucci, director of Invasive Cardiology Division, Careggi Hospital
Careggi Hospital
Not Provided
Study Chair: David Antoniucci, MD Careggi Hospital, Division of Invasive Cardiology
Principal Investigator: Francesco Prati, MD Rome Heart Research
Careggi Hospital
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP