Back to resultsMechanism Of Stent Thrombosis (MOST) Study (Most)
Primary Purpose
Coronary Artery, Stent Thrombosis, Platelet
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
OCT guided PCI
OCT guided medical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery focused on measuring Stent Thrombosis, Percutaneous Coronary Intervention, Bare Metal Stent, Drug Eluting Stent, Residual Platelet Reactivity, Optical Coherence Tomography, OCT
Eligibility 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).
Sites / Locations
- Careggi Hospital, Department of Hearth and Vessels
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Stent Thrombosis
Controls
Arm Description
Consecutive patients with stent thrombosis with stent strut assessment by OCT
Control subjects without stent thrombosis from the RHR OCT database
Outcomes
Primary Outcome Measures
Percentage of uncovered stent struts
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01410539
Brief Title
Mechanism Of Stent Thrombosis (MOST) Study
Acronym
Most
Official Title
Mechanism Of Stent Thrombosis (MOST) Study, a Prospective Multicentre Non-randomized Registry
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Careggi Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery, Stent Thrombosis, Platelet, Thrombus
Keywords
Stent Thrombosis, Percutaneous Coronary Intervention, Bare Metal Stent, Drug Eluting Stent, Residual Platelet Reactivity, Optical Coherence Tomography, OCT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stent Thrombosis
Arm Type
Experimental
Arm Description
Consecutive patients with stent thrombosis with stent strut assessment by OCT
Arm Title
Controls
Arm Type
Active Comparator
Arm Description
Control subjects without stent thrombosis from the RHR OCT database
Intervention Type
Device
Intervention Name(s)
OCT guided PCI
Intervention Description
OCT guided PCI. Only thrombectomy in case of negative OCT findings (other than uncovered struts).
Intervention Type
Drug
Intervention Name(s)
OCT guided medical therapy
Intervention Description
OCT guided medical therapy. Tailored antiplatelet therapy.
Primary Outcome Measure Information:
Title
Percentage of uncovered stent struts
Description
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.
Time Frame
After thrombectomy
Secondary Outcome Measure Information:
Title
Percentage of malapposed stent struts
Description
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.
Time Frame
After Thrombectomy
Title
Percentage of patients with high residual platelet reactivity
Description
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.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Antoniucci, MD
Organizational Affiliation
Careggi Hospital, Division of Invasive Cardiology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Francesco Prati, MD
Organizational Affiliation
Rome Heart Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Careggi Hospital, Department of Hearth and Vessels
City
Florence
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
24384290
Citation
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.
Results Reference
derived
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Mechanism Of Stent Thrombosis (MOST) Study
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